NABI BIOPHARMACEUTICALS : CYTR - in à 0,79$ hier soir

prisuttu

11 mai 2011 •04:36

http://seekingalpha.com/article/268998-cytrx-a-cancer-drug-developer-evidently-u ndervalued?source=yahoo

Profil supprimé

12 mai 2011 •01:18

salut sacha,

je rentre d'1 mois de vacances, j'ai perdu pas mal contact avec les biotechs.

Mais normalement :
- pour le Q2 lancement Ph2 Inno206 et data Ph2 Leukemia Bafetinib
- pour le Q3 data Ph2 Star1 Tamibarotene et data Ph2 Prostate Bafetinib

Profil supprimé

17 mai 2011 •15:00

Merci pour le tuyau Opif, je suis rentré à .85 il a quelques jours,pre-open + 20%.



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CytRx Completes Sale of Molecular Chaperone Assets to Orphazyme ApS in Deal Worth up to $120 Million
- Potential milestone payments represent substantial return on investment as CytRx executes on monetization strategy to support advancement of oncology programs -
- Completes strategic transformation into dedicated oncology company, with six clinical trials ongoing and an additional clinical trial planned -
- Opportunity to develop molecular chaperone therapy for the treatment of lysosomal storage diseases -
- Copenhagen-based Orphazyme backed by Novo A/S and Sunstone Capital -

LOS ANGELES, May 17, 2011 (BUSINESS WIRE) --

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has sold the worldwide rights to its molecular chaperone assets to privately-held, Copenhagen, Denmark-based Orphazyme ApS. If all of the development and commercialization milestones in the transaction agreement are met, in addition to an up-front payment, CytRx could receive total payments of up to $120 million, in addition to royalties on sales of products developed by Orphazyme from its molecular chaperone technology. This transaction represents the completion of CytRx's previously announced, non-dilutive monetization strategy for its non-core assets.


"This could be a game-changing transaction for CytRx with an ultimate potential value that exceeds our current market capitalization," said President and Chief Executive Officer Steven A. Kriegsman. "It illustrates our exceptional execution of a strategy to acquire assets and add value, in this case through multiple clinical and preclinical trials, then monetize them to support our focus on oncology."

Orphazyme was formed in 2009 to develop molecular chaperone therapies to treat rare genetic lysosomal diseases. Orphazyme develops innovative new therapies for the treatment of a family of serious genetic disorders called lysosomal storage diseases. The company's strategy is based on pioneering discoveries on the cytoprotective properties of human heat shock proteins, with the aim of developing paradigm-changing treatments for lysosomal storage diseases.

Orphazyme is backed by Novo A/S and Sunstone Capital. Novo A/S, which is wholly owned by the Novo Nordisk Foundation, is an international financial venture fund with offices in Copenhagen, San Francisco and London. Sunstone Capital is a Nordic-based early stage venture capital investor founded by an international team with more than 200 years of combined entrepreneurial, operational and financial experience.

The CytRx molecular chaperone portfolio includes three drug candidates, arimoclomol, iroxanadine and bimoclomol, which are orally administered molecular chaperone amplifiers. The compounds collectively have proven to be safe and well tolerated in more than 680 human subjects tested in 13 Phase 1 and six Phase 2 clinical trials. By targeting the underlying cause of many diseases, this novel approach has the potential to be developed for a broad variety of indications, including genetic diseases.

Mr. Kriegsman added, "We are delighted to place these important molecular chaperone assets in the hands of the world-class scientists at Orphazyme for further development with the ultimate goal of commercialization. We are pleased that the management team and Board of Directors of Orphazyme share our vision that molecular chaperones have the potential to improve the lives of patients worldwide. This transaction provides us with additional resources to focus on our highly promising oncology drug candidates."

Orphazyme Chief Executive Officer Anders Hinsby, Ph.D., stated, "We are developing paradigm-changing medicines for the treatment of individuals with inherited genetic lysosomal storage diseases for which there are currently no cures. All of these diseases share a common characteristic in that they originate from a deficiency in the ability of the lysosomes to metabolize macromolecules. We believe that CytRx's molecular chaperone technology can be used to revert lysosomal pathology through the induction of heat shock proteins, such as HSP70, and thus can be applied to develop new treatments for these diseases."

CytRx is focused on advancing its oncology portfolio and currently has six clinical trials underway and one additional clinical trial planned with its oncology drug candidates, bafetinib, tamibarotene and INNO-206. Preliminary data from the Company's clinical trial of bafetinib in advanced-stage leukemia is expected this quarter. In pursuing its strategy to monetize non-oncology assets, CytRx recently completed its sale of common stock in RXi Pharmaceuticals (Nasdaq: RXII), successfully raising a total of approximately $17 million from its former RNAi assets. Additionally, CytRx received 163,000 shares of common stock of ADVENTRX Pharmaceuticals (of which approximately 20% are being held in escrow) in exchange for its 19.1% stake in SynthRx. If all milestones under that agreement are achieved, CytRx could receive up to 2.9 million additional shares of ADVENTRX. The last sale price of ADVENTRX (NYSE Amex: ANX) shares on the NYSE Amex on May 13, 2011 was $2.58.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: bafetinib, tamibarotene and INNO-206. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. With its tumor-targeting drug candidate INNO-206, CytRx plans to initiate Phase 2 proof-of-concept clinical trials as a treatment for soft tissue sarcomas, following an abbreviated safety trial. CytRx's pipeline also includes tamibarotene, which it is testing in patients with non-small-cell lung cancer and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

About Orphazyme

Orphazyme develops innovative new therapies for the treatment of a family of serious genetic disorders called lysosomal storage diseases, and is based on discoveries emerging from the academic laboratory of its scientific founders: Professor Marja Jäättela and Thomas Kirkegaard Jensen from the Danish Cancer Society (Kræftens Bekæmpelse). Orphazyme is based in Copenhagen and has established collaborations with top-tier academic institutions in Europe and the United States. For more information on Orphazyme, visit http://www.orphazyme.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve substantial risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties related to the achievement of any of the milestones for payments to CytRx under the sale agreement with Orphazyme and the commercialization by Orphazyme of any molecular chaperone technology products and the possibility that the actual payments received by CytRx under the sale agreement will differ substantially from the maximum potential payments, as well as risks and uncertainties related to the outcome, timing and results of clinical trials of CytRx's oncology drug candidates, uncertainties regarding regulatory approvals for current and future clinical testing and the scope of the clinical testing of CytRx's oncology drug candidates that may eventually be required by regulatory authorities, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx's oncology drug candidates, and the other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.



SOURCE: CytRx Corporation

Investor RelationsLegend Securities, Inc.Thomas Wagner800-385-5790 x152718-233-2600 x152twagner@legendsecuritiesinc.com

Profil supprimé

17 mai 2011 •20:31

Salut M342 (ou Kristof ?),

malheureusement la hausse en pre-open n'a pas tenu, c'est quand même une hausse sympa vu le marché.

Je n'attendais pas une telle nouvelle à vrai dire. Vendre 120M$ les actifs sur lesquels Cytrx ne misait plus, c'est vraiment intéressant. Dommage que le montant de l'upfront payment ne soit pas précisé.

Pour mémoire, capi de Cytrx est à moins de 100M$ et cash dispo à fin Q1 est à 30M$ (+160.000 actions d'Adventrx).

prisuttu

20 mai 2011 •19:48

CytRx Corp. Stock Review: Primed for Growth by: Everyday Finance May 20, 2011 | about: AMGN, CYTR Font Size: PrintEmail Recommend 0 Share this page
Share0 In another installment of highlighting various investment opportunities, today, I'm going to cover CytRx Corporation (CYTR). As a biotech guy myself, I'm always interested in up and coming biotech outfits. Not only do they often have the potential to jump 100% or more in a single day when a pivotal drug study is released or a new drug is approved, but given the paltry research pipelines in big pharma, these cash-rich companies are scooping up biotechs left and right, often at premiums exceeding 100% as well. So, here's some background on CytRx:

Pipeline: 3 Oncology Compounds with Human Data
Platform: Technology to deliver anti-cancer agents directly to tumor
Key Pipeline Compound INNO-206

I was looking at some of the publicly available info on their pipeline and there's a lot of excitement around INNO-206. Most recently, the drug was granted FDA approval for orphan drug designation for pancreatic cancer (press release). With this designation, generally, an orphan drug can enjoy market exclusivity for a seven year period, realize tax credits on clinical trial expenses and sometimes be exempt from the FDA user fee (estimated at $1.8 Million). These are all beneficial accoutrements of the orphan drug status aside from the fact that the FDA thinks highly enough of the prospects for the compound to review and approve the designation. CytRx believes INNO-206 has attributes that improve on native doxorubicin (a commonly prescribed chemotherapeutic) including a reduction in adverse events, efficacy improvements and more targeted tumor delivery. This molecule is presently moving into Phase II. Other key compounds include Tamibaratone and Bafetinib (both in Phase II), which will be reviewed separately.

In the News

Just this week, there was a pretty big announcement (TheStreet.com) outlining the completion of the sale of Molecular Chaperone Assets To Orphazyme in a deal worth up to $120 Million. In a report from Zacks Research, the analyst put a $1.80 price target on the stock, which indicates a ~100% return from current prices. Obviously, with no commercial drugs approved, there are no revenues from that aspect each year, but Zacks has predicted that their diversified oncology portfolio represents substantial commercial potential. As evident by the lucrative margins enjoyed by the likes of key cancer players like Genentech and Amgen (AMGN), cancer drugs are sometimes relatively low-volume but command monthly fees of $10,000 dollars or more. Any estimates of pricing and volumes for CrtRx molecules would be premature at this time, but the simple notion of multiple candidates moving through the pipeline, the potential multi-billion dollar market potential and acquisition premiums are certainly driving forces to drive shares higher in the coming year.

Disclosure

This is part of a paid, but independent Research Series on CytRx. The views and opinions expressed in this Series are purely my own. I have no positions in CytRx, and no plans to initiate any positions within the next 72 hours.. Please review the Disclosure Policy relevant to this series.

Profil supprimé

23 mai 2011 •06:16

superbe eliott

Profil supprimé

13 juin 2011 •12:15

CytRx (NASDAQ:CYTR): Looking For The Next Dendreon (NASDAQ:DNDN)?
No CommentsPosted 12 Jun 2011
Category BioTech, CYTR, DNDN, Market News, Pharmaceuticals, Stocks, Trading By VFC’s Stock House

CytRx Corporation (NASDAQ:CYTR), with a rapidly advancing pipeline and money in the bank, may be skimming below the radar for investors searching for an undervalued company that might be gearing up to make a big splash in the cancer treatment sector.

Companies with products that are not yet beyond Phase II, which I like to refer to simply as ‘Phase II companies’, are considered by some to be highly risky investments since a lot can happen between Phase II trials and an FDA approval, but some of the best deals in the biotech/health care sector can be found by searching out a good ‘Phase II’ company trading for a reasonable price with a pipeline of potential.

For instance, shares of Keryx Biopharmaceuticals (NASDAQ:KERX) were trading for roughly the same price as the CYTR stock is now when that company was also considered a ‘Phase II company’. As we have seen with KERX, once the Phase II trial results started rolling in and Phase III were underway, shares appreciated significantly and now trades with a market cap of over three times that of CYTR.
Given the potential of the CytRx pipeline, which contains two solid Phase II products, it’s quite possible that CYTR shares will experience a similar pattern and could be trading for considerably higher prices as the time draws nearer to the release of Phase II results. Should those results turn out positive, and the products move on to Phase III, then an even more pronounced increase in price could be realized.

Something else to like about this company’s pipeline is the fact that it has a built-in insurance plan. In addition to its two lead products, Bafetinib and Tamibarotene, INNO-206 serves as a third product candidate that provides a cushion – or a ‘Plan C’ – should one or both of the more-advanced product candidates hit a road block or experience a setback in development.

Having a third candidate in the pipeline is a luxury that many small, aspiring companies in this sector can enjoy. Even those small companies that can boast multiple product candidates often cannot fund trials for each one simultaneously, which is something that CytRx is successfully managing.

Of the three product candidates, Bafetinib may hold the most market potential. This product is being investigated for effectiveness in treating multiple cancer indications, including advance prostate cancer, brain cancer and leukemia. According to statistics posted by the Center for Disease Control and Prevention (CDC), prostate cancer is the number one cancer suffered by men. 217,730 new cases were reported in the US alone last year, according to data supplied by the National Cancer Institute, and any move into that market by CytRx is sure to become a lucrative undertaking while significantly boosting shareholder value.

The second Phase II candidate, Tamibarotene, is being tested as a for treatment of non-small cell lung (NSCL) cancer and acute promyelocytic leukemia (APL). CytRx would only need to make a small dent into the NSCL market to significant boost the company’s bottom line, and APL is a $100 million market in itself.

INNO-206, although still earlier in the stages of development, could also become a big player as an anti-tumor agent. Multiple studies are underway and the product has already demonstrated success in early animal and human clinical studies. This will be a product to keep a keen eye on as the others develop.

One major concern that all potential investors have when investing in the biotech/health care sector is how a company will fund its clinical development. Dilution is the largest of concerns, as shareholder value becomes diluted along with the stock, but CytRx has undertaken a strategy of finding non-dilutive alternatives to fund its developmental stage, and thus far it’s been a successful strategy.

CYTR issued a press release last month announcing the sale of the worldwide rights for its molecular chaperone assets to the privately-held Orphazyme ApS, based in Copenhagen, Denmark.

For a small company such as CytRx, this was no insignificant deal.

The total value of the transaction, should all milestones be met, could be worth up to $120 million, which today is roughly 20% more than the current market cap of CYTR.

In addition to an up-front payment and the milestone potential, CytRx will receive royalties on all sales of products utilizing the molecular chaperone technology. Give it some time, and this deal could turn out to be a coup for the company.

CEO Steven A. Kriegsman noted as such in a recent press release:

“This could be a game-changing transaction for CytRx with an ultimate potential value that exceeds our current market capitalization.”

He then went on to comment about the company’s strategy of funding its oncology pipeline through investments that are non-dilutive to shareholders:

“It illustrates our exceptional execution of a strategy to acquire assets and add value, in this case through multiple clinical and preclinical trials, then monetize them to support our focus on oncology.”

The management team looks to be navigating this strategy with success and precision, as the company also raised $17 million in a sale of RXII stock. Additionally,

CytRx received 163,000 shares of ANX in exchange for its 19.1% stake in SynthRx, according to the above-noted press release.

Given the recent developments at CytRx, the solid pipeline and success in adding funds to the war chest in a non-dilutive manner, CYTR might not be trading below the radar for too much longer.

Worth taking a look.

Disclosure: No position and no plans to initiate a position in the next 72

prisuttu

13 juin 2011 •16:10

CytRx Reports Positive Preliminary Results from ENABLE Phase 2 Clinical Trial with Bafetinib in Patients with Relapsed B-Cell Chronic Lymphocytic Leukemia
– Bafetinib Demonstrates Clinical Activity in B-CLL Patients Who Failed Other Treatments –

– Additional Trial Patients to Receive Bafetinib at Higher Doses as Important Next Step –




tweet0EmailPrintCompanies:CytRx Corporation Related Quotes
Symbol Price Change
CYTR 0.82 +0.03


{"s" : "cytr","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: CytRx Corporation On Monday June 13, 2011, 10:00 am

LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (Nasdaq:CYTR - News), a biopharmaceutical company specializing in oncology, today announced that preliminary results from its ENABLE Phase 2 proof-of-concept trial demonstrated that bafetinib, the Company’s Bcr-Abl, Lyn and Fyn kinase inhibitor, was clinically active in a group of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments for their cancer. Based on this indication of clinical activity and the low incidence of adverse events, additional patients enrolled in the ENABLE Phase 2 clinical trial will receive bafetinib as a single agent at a higher dose.



“We are highly optimistic about bafetinib’s prospects based on the preliminary results, which provide an initial indication that this drug candidate’s unique kinase inhibition could be efficacious in treating B-CLL and other cancers where approved therapies have failed,” said CytRx President and CEO Steven A. Kriegsman. “Due to the low incidence of adverse events, we are now able to increase the dose of bafetinib administered to newly enrolled patients, thus increasing the potential for greater efficacy.”



Of the 16 patients enrolled in the ENABLE Phase 2 clinical trial, 11 patients were evaluable for tumor response (patients who have received both baseline and follow-up tumor assessments). At the time of evaluation, the median duration of treatment for all patients was two months, and five of these 11 patients had received three to five months of bafetinib therapy; five patients either did not receive baseline or follow-up assessments. The median number of prior therapies for the full group is three, with a range between one and five prior therapies, and nine of 12 patients demonstrated unfavorable cytogenetics (del 17p; 13). This subgroup of patients typically has fast disease progression and shorter median overall survival.



All 11 evaluable patients demonstrated ≥50% elevation in their lymphocyte counts during the first two months of treatment, similar to other kinase inhibitors being tested in B-CLL patients. Six demonstrated >50% shrinkage in their lymph nodes and/or spleen, two patients had stable disease and three patients had progressive disease at their initial assessments. Lymph node softening also was noted in these patients. Only one grade 3 or 4 adverse event (grade 3 elevated liver enzymes) was noted, which resolved when bafetinib administration was ceased. Grade 1 and 2 adverse events included elevated liver enzymes with normal bilirubin, fatigue and gastrointestinal symptoms.



“These favorable initial Phase 2 clinical trial results of bafetinib’s activity and safety mark an important step in our goal to become a leading oncology therapeutics company. Further, we were able to obtain these results quickly after initiating enrollment in this clinical trial, validating our strategy to rapidly and cost-effectively conduct proof-of-concept trials in patients with advanced-stage cancers prior to moving into larger clinical trials,” Mr. Kriegsman added.



The ENABLE Phase 2 clinical trial, which is expected to enroll a total of 30 patients, is being performed at M.D. Anderson Cancer Center, City of Hope Medical Center and Cancer Care Centers of Texas. Patients self-administer bafetinib twice daily every day and continue treatment as long as their cancer is controlled and no intolerable side effects occur. The trial’s objectives are to assess preliminary efficacy of administration of bafetinib in B-CLL patients and evaluate its safety in this patient population.



“These results are very encouraging,” said Daniel Levitt, M.D., PhD, Chief Medical Officer at CytRx. “Lyn kinase, a primary target of bafetinib, is important to the activation and growth of B cells. It is upstream from both PI3kinase delta and Bruton’s tyrosine kinase in B-CLL and may regulate the activity of these other kinases in B cell malignancies.”



B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL are reported in the U.S. each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients in the high-risk B-CLL have a median overall survival of one to five years.



About Bafetinib



CytRx holds rights to bafetinib (formerly known as INNO-406) in all territories except Japan. Bafetinib is a potent, orally available, rationally designed, Bcr-Abl, Lyn and Fyn kinase inhibitor, which was being developed as a third-line treatment for patients with CML and certain forms of acute myeloid leukemia (AML) that are refractory or intolerant of other approved treatments. In November 2008, CytRx announced that bafetinib demonstrated clinical responses in patients with CML in an international, open-label Phase 1 dose-ranging clinical trial conducted in patients with CML and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to Gleevec® and, in some cases, second-line tyrosine kinase inhibitors such as dasatinib and nilotinib. In April 2010, the Company announced that bafetinib had received official notification from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA) that a positive opinion was made regarding the application for orphan medicinal product status for the treatment of chronic myeloid leukemia (CML). Bafetinib also has been granted Orphan Drug Status for the treatment of Ph+ CML by the U.S. Food and Drug Administration (FDA).



About CytRx Corporation



CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: bafetinib, tamibarotene and INNO-206. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. With its tumor-targeting oncology candidate INNO-206, CytRx plans to initiate a Phase 2 clinical trial as a treatment for soft tissue sarcomas, following a dose escalation safety trial. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

prisuttu

14 juin 2011 •12:08

CytRx Reports Positive Phase II Preliminary Results

tweet0EmailPrintCompanies:CytRx Corporation Related Quotes
Symbol Price Change
CYTR 0.80 0.00


{"s" : "cytr","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Zacks Equity Research, On Monday June 13, 2011, 4:30 pm EDT

Grant Zeng, CFA

CytRx Reports Positive Phase II Preliminary Results

On June 13, 2011, CytRx Corporation (CYTR) announced preliminary positive results from its ENABLE Phase II proof-of-concept trial of bafetinib for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

As a reminder, in May 2010, CytRx initiated a Phase II proof-of-concept clinical trial (ENABLE) with bafetinib as a second line treatment for B-CLL due to the potent and specific inhibitory properties of bafetinib against Lyn and Fyn kinases, which are overexpressed in B-CLL cancers.

In this clinical trial, high-risk B-CLL patients who have failed treatment with first-line agents will self-administer oral doses of bafetinib twice daily. The bafetinib dose used in this trial is based on the highest dose that was best tolerated in the Phase I study. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Total of 30 patients will be enrolled. The dose of bafetinib may be escalated to 360 mg twice daily if relatively few side effects are observed at the 240 mg twice daily dose. The endpoint of this Phase II trial is objective response rate (30% ORR is target). MD Anderson is the primary US site.

Of the 16 patients enrolled in the ENABLE Phase II clinical trial, 11 patients were evaluable for tumor response (patients who have received both baseline and follow-up tumor assessments). At the time of evaluation, the median duration of treatment for all patients was two months, and five of these 11 patients had received three to five months of bafetinib therapy; five patients either did not receive baseline or follow-up assessments. The median number of prior therapies for the full group is three, with a range between one and five prior therapies, and nine of 12 patients demonstrated unfavorable cytogenetics (del 17p; 13). This subgroup of patients typically has fast disease progression and shorter median overall survival.

All 11 evaluable patients demonstrated ≥50% elevation in their lymphocyte counts during the first two months of treatment, similar to other kinase inhibitors being tested in B-CLL patients. Six demonstrated >50% shrinkage in their lymph nodes and/or spleen, two patients had stable disease and three patients had progressive disease at their initial assessments. Lymph node softening also was noted in these patients. Only one grade 3 or 4 adverse event (grade 3 elevated liver enzymes) was noted, which resolved when bafetinib administration was ceased. Grade 1 and 2 adverse events included elevated liver enzymes with normal bilirubin, fatigue and gastrointestinal symptoms.

The initial results are encouraging. The Phase II study demonstrated that bafetinib is clinically active in a group of patients with relapsed B-CLL who have failed several other treatments for their cancer. Based on this indication of clinical activity and the low incidence of adverse events, additional patients enrolled in the ENABLE Phase II clinical trial will receive bafetinib as a single agent at a higher dose. This increased dosage could increase the potential for greater efficacy.

B-CLL is the most common form of leukemia in adults in Western countries. More than 17,000 new cases of B-CLL are reported in the United States alone each year; however up to an estimated 40% of cases may not be reported due to under-diagnosis and lack of placement in cancer registries. Virtually all patients are older than 55 years at presentation, with an average age of 70 years. Patients in the high-risk B-CLL classification have a median overall survival period of one to five years.

We have an Outperform rating on CytRx with a twelve-month price target of $1.80

prisuttu

14 juin 2011 •15:34

CytRx: Small Oncology Firm Offers Unique Exposure to Big Pharma Culture by: Timeless Wealth June 14, 2011 | about: CYTR Font Size: PrintEmail Recommend 0 Share this page
Share0 inShare0New drug approvals are on track to breach levels last seen at the turn of the 21st century (observe chart below). Midway through 2011, the Food & Drug Administration has already given the thumbs up to 16 applicants, as of last week.
[Click to enlarge]

Source: FDA
The FDA provides a detailed schedule of approved compounds in its Spotlight on Drug Innovation page, where, almost unanimously, healthcare conglomerates like Bristol-Myers Squibb (BMY), Forest Laboratories (FRX), GE Healthcare (GE), and others, govern. Leveraging their economic resources, state-of-the-art technologies, and know-how, these healthcare moguls are able to push drugs past the FDA hurdle, where small innovators often lack needed experience.

At CytRx (CYTR), the team that overlooks the development of the Los Angeles-based clinical-stage oncology firm has brought a combined six compounds to market. The company’s management comprises one of the most talented pool of executives in the healthcare sector, offering investors an exotic combination of coveted know-how at unprecedented prices.

In an interview with Reuters in May, Dr. Janet Woodcock, head of the FDA's drugs center, discussed the FDA’s tightening of requirements for winning approval, which gives the experienced leadership at CytRx a significant competitive advantage over peers, having been there previously.

Personalities Who Have Gone the Distance

CytRx chief executive Steven A. Kriegsman helped fund decitabine, a compound that found FDA approval in 2006 for the treatment of patients with myelodysplastic syndromes (MDS). SuperGen (SUPG) markets the drug under the brand name Dacogen. David Haen, VP of business development at CytRx, is said to have played an important role in the process that led to FDA approval.
Scott Geyer, senior VP of manufacturing at CytRx, was instrumental in the development of oncology drug Nexavar, which is distributed by Onyx Pharmaceuticals (ONXX) to patients with kidney and liver cancer. In 2005 the compound received FDA approval for the treatment of patients with kidney cancer; Onyx’s Nexavar was given the go-ahead by the FDA for treating liver cancer two years later.
Chief medical officer Dr. Daniel Levitt was integral in the development of Leucomax, interleukin-3, interleukin-6, Sandostatin and PSC-833 during his tenure at Sandoz Pharma, a division of Novartis (NVS). As director of clinical oncology and immunology at Roche (RHHBY.PK), Dr. Levitt introduced interleukin-2, one of the first FDA-approved therapies for the treatment of melanoma. Earlier this year, Bristol-Myers Squibb’s Yervoy became the first melanoma drug to receive FDA approval since interleukin-2.
CytRx provides investors exposure to big pharma culture at little pharma prices. In an earlier report, we broke down the intrinsic value of shares of the oncology company, agreeing with analysts’ median price target of $2 in that CytRx was, and still is, evidently undervalued.
CytRx has erected trials for three novel compounds in seven kinds of cancer. On Monday, the company announced encouraging preliminary results from their Phase II trials involving bafetinib in B-Cell CLL (leukemia):
Preliminary results from its ENABLE Phase 2 proof-of-concept trial demonstrated that bafetinib, the Company's Bcr-Abl, Lyn and Fyn kinase inhibitor, was clinically active in a group of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments for their cancer. Based on this indication of clinical activity and the low incidence of adverse events, additional patients enrolled in the ENABLE Phase 2 clinical trial will receive bafetinib as a single agent at a higher dose.

In the Reuters interview, Dr. Woodcock explains that the increasing number of new drug approvals has everything to do with the quality of applicants the FDA is receiving. CytRx has done well to offer investors reduced risk by extending pipeline exposure to seven indications, improving the firm’s chance at commercializing a drug for one or more cancers.
Where CytRx lags to leading biotechnology firms, management’s deep industry experience is largely a compensable factor that brings it back to par -- and then some.
Disclosure: I am long CYTR

Profil supprimé

05 juillet 2011 •14:54

CytRx Receives FDA Orphan Drug Designation for INNO-206 for the Treatment of Soft Tissue Sarcomas Company plans to initiate INNO-206 Phase 2b clinical trial in advanced soft tissue sarcomas in the second half of 2011
Published: Tuesday, 5 Jul 2011 | 8:30 AM ET Text Size

LOS ANGELES, Jul 05, 2011 (BUSINESS WIRE) -- CytRx Corporation (Nasdaq: CYTR), a biotechnology company specializing in oncology, today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas. Soft tissue sarcomas are cancers that are formed in the muscle, fat, fibrous tissue, blood vessels or other supporting tissue of the body. CytRx holds the exclusive worldwide development and commercialization rights to INNO-206.

INNO-206 is a novel conjugate of doxorubicin, a commonly prescribed chemotherapeutic, and was designed to improve efficacy and reduce adverse events through controlled release and preferential targeting of tumors. Doxorubicin is currently the only FDA-approved drug on the market for soft tissue sarcoma, and is a standard chemotherapeutic treatment for a variety of other cancers. In April 2011, the FDA granted INNO-206 orphan drug designation for treating patients with pancreatic cancer.

CytRx plans to begin a Phase 2b clinical trial with INNO-206 in patients with late-stage soft tissue sarcomas in the second half of 2011, following completion of an ongoing open-label Phase 1b clinical trial in patients with advanced solid tumors who have failed standard therapies. The Phase 1b clinical trial, which consists mostly of patients with soft tissue sarcomas, is evaluating the safety of administering doses of INNO-206 that are more than two to four times the standard dose of doxorubicin.

"Our strategy to move quickly into a Phase 2b trial with INNO-206 in soft tissue sarcomas is further supported by the FDA's approval of orphan drug designation," said Steven A. Kriegsman, President and CEO of CytRx. "We envision a significant opportunity in this indication due to the objective clinical responses seen with INNO-206 in patients with sarcomas in an earlier Phase 1 trial as well as preclinical data." Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis. Progression-free survival for this group is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years.

Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival.

In the United States, under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country.

The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA requirements. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee.

About CytRx Corporation CytRx Corporation is a biopharmaceutical research and development oncology company engaged in the development of high-value human therapeutics. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx plans to initiate a Phase 2b clinical trial as a treatment for soft tissue sarcomas, following a Phase 1b dose escalation safety trial. The Company is evaluating bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL) and the PROACT Phase 2 clinical trial in advanced prostate cancer, and is conducting a pharmacokinetic clinical trial in brain cancer. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind placebo-controlled Phase 2 clinical trial in patients with non-small-cell lung cancer, and which is in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL). For more information on the Company, visit http://www.cytrx.com.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the outcome, timing and results of CytRx's clinical testing for INNO-206 in patients with soft tissue sarcomas, uncertainties regarding regulatory approvals for current and future clinical testing of INNO-206 and the scope of the clinical testing that may eventually be required by regulatory authorities for INNO-206, the significant time and expense that will be incurred in developing any of the potential commercial applications for INNO-206, including for soft tissue sarcomas, the risk that any future human testing of INNO-206 for might not produce results similar to those seen in animals, risks related to CytRx's ability to manufacture its drug candidates, including INNO-206, in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of INNO-206, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: CytRx Corporation CONTACT: Investor Relations Legend Securities, Inc. Thomas Wagner 800-385-5790 x152 718-233-2600 x152 twagner@legendsecuritiesinc.com Copyright Business Wire 2011 -0- KEYWORD: United States

Profil supprimé

06 juillet 2011 •16:21

Cytrx annonce de bons resultats intermediaires sur la securite d'Inno206 (phase 1b). Confirmation donc du lancement d'une phase 2b au 2e semestre pour "soft tissue sarcomas".

Je m'attendais aussi a une prochaine phase 2b Inno206 pour "pancreatic cancer" qui a aussi obtenu le statut "orphan drug" en avril ou mai, mais pas de news sur celle-la depuis.

CytRx Announces Safe Administration of High Doses of Doxorubicin with Its Tumor-Targeted Drug, INNO-206
6 July 2011
Business Wire

-- No Dose-Limiting Side Effects in Phase 1b Clinical Trial at More Than a Four-Fold Increase in Standard Doxorubicin Dose --

-- Company Plans Escalation to Higher Doxorubicin Doses to Determine Maximum Tolerated Dose --

-- Initiation of INNO-206 Phase 2b Clinical Trial in Advanced Soft Tissue Sarcomas Planned for the Second Half of 2011 --

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that its tumor-targeted doxorubicin conjugate, INNO-206, is delivering doxorubicin safely at doses over 4 times higher than the standard doxorubicin dose in the Company's open-label Phase 1b safety and dose escalation clinical trial. The clinical trial is being conducted in up to 24 patients with advanced solid tumors who have failed standard therapies.

All eight patients treated in the Phase 1b trial to date were diagnosed with advanced soft tissue sarcomas. Doxorubicin is currently the only FDA-approved drug on the market as a treatment for soft tissue sarcoma and is a standard chemotherapeutic treatment for a variety of other cancers. It is used either alone or in combination with other chemotherapy agents. Dose levels of doxorubicin are limited due to its toxicity. INNO-206 is a novel conjugate of doxorubicin that binds covalently to albumin, the most abundant protein in blood plasma, and is circulated throughout the body. INNO-206 is designed with a linker that releases doxorubicin in the low pH environment of tumors, concentrating the chemotherapeutic agent where it preferentially damages the tumor while minimizing the effect on healthy tissues.

The Phase Ib trial is being conducted at the Sarcoma Oncology Center in Santa Monica, California, under the direction of Sant P. Chawla, M.D., F.R.A.C.P, a leading expert in sarcomas and sarcoma therapies. "The safety profile of INNO-206 thus far has been impressive," stated Dr. Chawla. "After repeat doses that are more than four-fold higher than the dose of doxorubicin that we use to treat patients with soft tissue sarcomas, side effects have been generally mild and readily reversible. We are continuing treatment and dose escalation in our study." During his tenure at the Sarcoma Oncology Center, Dr. Chawla has studied virtually every important drug being tested to treat soft tissue sarcomas.

"The ability to administer dramatically higher doses of doxorubicin with INNO-206 could represent a major breakthrough in the treatment of various cancers in which doxorubicin is an important component of chemotherapy regimens," said CytRx President and CEO Steven A. Kriegsman. "Although it is too early in the trial to assess clinical response, we believe that the ability of our conjugate formulation to safely deliver greater amounts of doxorubicin directly to the tumor compared with standard doxorubicin treatment can lead to improved efficacy. We plan to rapidly enter a Phase 2b clinical trial with INNO-206 in patients with soft tissue sarcomas in the second half of 2011 after completing this dose escalation safety study."

Patients in the Phase Ib trial are being administered with INNO-206 at two dose levels: 165 mg/m2 and 260 mg/m2 doxorubicin equivalents. These doses are 2.75 and 4.33 times higher than the standard dose of doxorubicin (60 mg/m2) administered to patients with soft tissue sarcomas. Side effects have been generally mild, with only one patient experiencing grade 3 or 4 neutropenia and thrombocytopenia that resolved without therapy. One patient discontinued INNO-206 due to disease progression after one month, but no patient has discontinued treatment due to toxicity.

CytRx holds the exclusive worldwide rights to INNO-206, which is CytRx's lead compound in its platform technology designed to reduce adverse events by controlling drug release and preferentially targeting tumors. Several other chemotherapy agents have been attached to the linker used for INNO-206, including paclitaxel, cisplatin and methotrexate, and may be incorporated into future clinical development by the Company.

Patients with advanced soft tissue sarcomas who can no longer be treated with surgery have a poor prognosis. Progression-free survival for this group is around six to seven months, and median overall survival is approximately 18 months with less than one-third of these patients living past three years. Combinations of the chemotherapy drugs ifosfamide and doxorubicin appear to offer the highest response rates and longest time to progression in these patients; however, these regimens have not significantly improved survival and are quite toxic.

drenan

27 juillet 2011 •15:33

http://www.thestreet.com/story/11199966/1/cytrx-prices-204-million-public-offeri ng.html

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has priced an underwritten public offering of 39,200,000 shares of common stock and warrants to purchase up to 39,200,000 shares of common stock at a combined public offering price of $0.52 per share and related warrant for gross proceeds of approximately $20.4 million. The warrants are exercisable immediately upon issuance at an exercise price of $0.64 per share and, unless exercised, will expire on the fifth anniversary of the date of issuance. CytRx has also granted the underwriters a 30-day option to purchase up to an additional 15 percent of shares of common stock and warrants offered in the public offering to cover over-allotments, if any, which would result in additional gross proceeds of approximately $3 million if exercised in full.

Profil supprimé

27 juillet 2011 •15:43

Ouf, suis sorti y a 2 semaines;))

drenan

27 juillet 2011 •17:32

ce cours

Profil supprimé

27 juillet 2011 •18:48

une fin de mois pourrie pour moi entre Transcept et Cytrx. J'ai encore du Cytrx, je reste quand meme assez confiant dans la mesure ou des resultats sont attendus au Q3, mais il y a une sacree pente a remonter maintenant...

Profil supprimé

27 juillet 2011 •19:28

Je te souhaite de connaitre des jours meilleurs, mais rassures toi, çà nous arrive à tous les gadins...

Y a que les mythos qui gagnent à tous les coups, lol !

Profil supprimé

27 juillet 2011 •19:33

Ouais David, exact, je faisais la même reflexion,et comme dit Opif, cette boite est quand même interessante, du coup, je viens de reprendre une lignette à .41, on rechargera + tard si necessaire.

Profil supprimé

27 juillet 2011 •20:06

merci bien Kristof mais je ne m'en fais pas trop.

J'accepte completement de faire les montagnes russes sur les biotechs, meme si en ce moment j'ai + de bas que de hauts.

J'espere que maintenant Cytrx va relever la tete. Sauf erreur, au Q3, il devrait y avoir les resus de phase 2 Prostate Bafetinib.

Profil supprimé

28 juillet 2011 •00:21

comment ils la justifient?

c'est mal acueilli et c'est justifié:

-leur AK prend de court tt le monde puisqu'ils avaient 33.83 mlns $ en Cash au 31 Mars

-ils avaient manifesté leur volonté de céder des actifs non-oncologiques (telle que sa technologie de régulation moléculaire) mais le message qui est envoyé au marché c'est plutot "personne n'en veut".

Ensuite, le marché apprèhende souvent (à juste titre?) qu'une biotech qui va lever du cash avant des résus importants va livrer de mauvais rèsultats.. moi je n'y crois pas trop mais c'est souvent l'idèe qui resort

Maintenant, si je comprends bien : ils vont avoir envion 50 Millions $ de Cash...

mais la question que je me pose est : pour quoi faire ??? c est uniquement pour sècuriser son financement???

Profil supprimé

28 juillet 2011 •18:59

Sacha, j'ai etais pris au depourvu aussi, je n'attendais pas d'AK aussi vite. Toujours est-il que leur AK doit surtout leur permettre de financer le developpement de leurs produits.

C'est un peu le "probleme" de Cytrx, ils ont beaucoup de phases 2 en cours ou pretes a demarrer (au moins 5 selon mon decompte), mais pas de produit commercialise pour financer la R&D. Moi, ce qui m'embete surtout, c'est qu'ils n'ont pas l'air de vouloir/pouvoir trouver des partenariats.

Pour les actifs non-oncologiques, si l'on parle bien de la meme chose, ils ont ete vendus a Orphazyme en mai (pour 120M$, mais j'imagine, faute d'info, que l'upfront payment est tres faible)

Profil supprimé

05 octobre 2011 •18:10

Le cours reste plombé vu le contexte boursier, mais quelques nouvelles devraient tombées au Q4.

- élargissement de l'enrollement d'Inno-206 pour Soft tissue sarcomas. Data prévus au Q4 selon moi.
- Données complètes sur la phase 2 Bafetinib pour leukemia mi-décembre à la convention de l'American Society of Hematology


CytRx increases patient enrollment in Phase Ib/II sarcoma tria
28 septembre 2011
Datamonitor News and Comment

CytRx Corporation, a biopharmaceutical company, has announced that it is tripling the number of patients in its Phase Ib/II clinical trial who will be treated with its tumor-targeting doxorubicin conjugate INNO-206 at the dose planned for its Phase IIb trial for the treatment of advanced soft tissue sarcomas.



CytRx's ENABLE Phase 2 Trial Results with Bafetinib in Relapsed B-Cell Chronic Lymphocytic Leukemia to be Presented at the Prestigious 53(rd) Annual ASH Meeting
4 octobre 2011
Business Wire

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that an abstract with results from the Company's ENABLE Phase 2 proof-of-concept clinical trial with its Bcr-Abl, Lyn and Fyn kinase inhibitor bafetinib for the treatment of patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL) who have failed several other treatments will be presented in a poster session at the 2011 American Society of Hematology (ASH(R) ) Annual Meeting on Sunday, December 11, 2011 at 6:00 p.m. Pacific time at the San Diego Convention Center, Hall GH. The abstract, "A Pilot Phase II Study of the Lyn Kinase Inhibitor Bafetinib in Patients with Relapsed or Refractory B Cell Chronic Lymphocytic Leukemia," also will be published in print and online in the November 18, 2011, supplemental volume of the peer-reviewed ASH journal Blood. The abstract was authored by Tapan Kadia, M.D., Maria Delioukina, M.D., Hagop Kantarjan, M.D., Michael Keating, M.D., William Wierda, M.D. and Jan Berger, M.D., as well as CytRx's Chief Medical Officer, Daniel, Levitt, M.D., Ph.D, and Senior Vice President of Drug Development, Scott Wieland, Ph.D.

drenan

27 octobre 2011 •18:37

ne pas l'oublier celle là

drenan

31 octobre 2011 •14:37

0.4 à passer

Profil supprimé

31 octobre 2011 •15:04

Les bons résultats pour leur phase 1b/2 sur Inno-206 font monter l'action. Lancement de la phase 2b en décembre.

Egalement des résultats de phase 2 sur Bafetinib à attendre ce trimestre.

CytRx Announces Favorable Initial Results from its Ongoing Phase 1b/2 Clinical Trial in Patients with Soft Tissue Sarcomas
31 octobre 2011
Business Wire

One patient exhibits a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease following four cycles of INNO-206 administration

INNO-206 international Phase 2b clinical trial in advanced soft tissue sarcomas expected to begin in December 2011

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced favorable response and safety indications from a group of patients with advanced solid tumors (principally soft tissue sarcomas) in the Company's ongoing Phase 1b/2 clinical trial with INNO-206, its tumor-targeting conjugate of the commonly used chemotherapeutic agent doxorubicin. Patients in this portion of the Phase 1b/2 clinical trial received three different dose levels of INNO-206 to determine its maximum tolerated dose.

In the initial Phase 1b portion of the clinical trial, 12 patients, primarily with advanced soft tissue sarcomas, have received one or more administrations of treatment with INNO-206 in three-week cycles. The Company determined a maximum tolerated dose of INNO-206 that delivers a doxorubicin equivalent of 3[1/2] times the standard doxorubicin dose administered to sarcoma patients. CytRx is currently enrolling additional patients who will be treated at that dose to gather further response data in parallel with the planned international Phase 2b clinical trial scheduled to start this quarter.

Of five patients who have completed four cycles with INNO-206 at the maximum tolerated dose, one patient has exhibited a partial tumor response (greater than 30% tumor shrinkage) and four patients have stable disease. Unexpectedly, a large, painful oral sarcoma that caused difficulty eating in one patient was greatly reduced following a single INNO-206 treatment. Common side effects reported to date from the Phase 1b/2 trial include low neutrophil (white blood cell) and platelet counts, minor mouth ulcers and mild nausea, which are expected side effects of doxorubicin.

"Initial data of response and safety from INNO-206 in this portion of the Phase 1b/2 trial are very important," said CytRx President and CEO Steven A. Kriegsman. "Although these initial results are from a limited number of patients, the individuals treated were very advanced in their disease and had previously received multiple different chemotherapy agents, including doxorubicin, so we are pleasantly surprised to observe stable disease, much less tumor shrinkage, in these cancer patients. We believe these early indications bode well for the potential success of our international Phase 2b clinical trial in patients who have advanced disease but were not previously administered chemotherapy."

"The response from this small group of patients treated with INNO-206 is encouraging and we look forward to sharing the full, final data from the Phase 1b/2 clinical trial in a presentation at ASCO 2012," said Sant P. Chawla, M.D., F.R.A.C.P. The Phase 1b/2 clinical trial is being conducted at the Sarcoma Oncology Center in Santa Monica, Calif. under the direction of Dr. Chawla, a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication.

In September 2011, CytRx announced completion of the maximum tolerated dose portion of the Phase 1b/2 trial, which included 12 patients. The patients from the early portion of the trial were evaluated for tumor response after four cycles of INNO-206. The Company also announced plans to add 12 patients to the Phase 1b/2 trial to receive INNO-206 at the maximum tolerated dose, and six of those additional patients have already been enrolled.

Profil supprimé

29 mars 2012 •14:01

c'est très à la mode en ce moment ...

"CytRx Corporation (NASDAQ:CYTR) said in a SEC filing that it intends to seek shareholder approval on May 14, 2012, to effect a reverse stock split in the range of between 1-for-3 and 1-for-12. The company earlier mentioned that it received notification on February 15, 2012 that because it had not regained compliance with the $1.00 minimum bid price requirement for continued listing, it would be subject to delisting from The NASDAQ Capital Market on or before February 22, 2012, unless it requested a hearing before a NASDAQ Hearings Panel. The company subsequently scheduled a meeting before the Panel.
According to NASDAQ, hearings are typically scheduled 30 to 45 days from the company’s request. The Panel generally issues a written decision approximately 35 days after the hearing, but the company could receive a written decision sooner.

Using the timeline supplied by NASDAQ above, a decision is likely to be rendered by NASDAQ between late-April and mid-May 2012."

prisuttu

23 avril 2012 •15:53

http://www.theflyonthewall.com/permalinks/entry.php/CYTRid1617886/CYTR-CytRx-rei nstated-with-a-Buy-at-Roth-Capital

Profil supprimé

23 avril 2012 •16:08

L'avais perdu de l'oeil celle là

Merci pour info

K

prisuttu

03 juin 2012 •17:51

CytRx Announces Favorable Results from Phase 1b/2 Clinical Trial with INNO-206
77% of evaluable advanced soft tissue sarcoma patients administered INNO-206 at the maximum tolerated dose showed clinical benefit of more than four months following treatment
Company plans to meet with the FDA to discuss a potential Phase 3 pivotal trial with INNO-206 as a third-line therapy in soft tissue sarcoma patients
Conference call to be held Monday, June 4 at 10:00 a.m. Eastern Time

Press Release: CytRx Corporation – 2 hours 45 minutes ago

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LOS ANGELES--(BUSINESS WIRE)--
CytRx Corporation (CYTR), a biopharmaceutical company specializing in oncology, announces that favorable clinical results from its Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate INNO-206 in patients with advanced solid tumors, primarily soft tissue sarcomas, are being presented today at the American Society of Clinical Oncology (ASCO) conference in Chicago. All patients in the study had either not responded to or relapsed after treatment with between one and three prior chemotherapy regimens.
Clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) with INNO-206 at the maximum tolerated dose was shown in 10 of 13 (76.9%) evaluable patients with relapsed or refractory soft tissue sarcoma.
In addition, best response for the 13 evaluable soft tissue sarcoma trial subjects included the following:
Five (38.5%) achieved partial response, as defined as tumor shrinkage of more than 30%
Seven (53.8%) showed prolonged stable disease (defined as tumor shrinkage <30% from baseline or tumor growth <20% from the nadir)
Eight (61.5%) had tumor shrinkage
Five of eight patients (62.5%) who demonstrated either partial responses or prolonged stable disease after treatment with INNO-206 had been previously treated with doxorubicin and had failed to respond.
There were no observed cardiac toxicities and no drug-related patient deaths. The most common adverse event, neutropenia, also observed with doxorubicin treatment, resolved prior to the start of the next treatment.
Median estimated progression-free survival for advanced soft tissue sarcoma patients in the trial was 6.4 months with a range of 1.0 to more than 10.7 months. This compares favorably with the historical median progression-free survival for this patient population of approximately 3 months.
The presentation at ASCO was made by the trial’s principal investigator Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, Calif. Dr. Chawla is a world-renowned expert in soft tissue sarcoma treatment who has evaluated most chemotherapies being tested in this indication. The poster, entitled “Phase 1b/2 Study of INNO-206 (EMCH-doxorubicin) in Patients with Soft Tissue Sarcoma,” was authored by Dr. Chawla, Victoria S. Chua, Andrew Hendifar, M.D., Doris Quon and Sandeep Nagre of the Sarcoma Oncology Center; Kristen N. Ganjoo, M.D. of Stanford University; Kamalesh Sankhala, M.D. of the University of Texas Health Science Center; and Scott Wieland, Ph.D. and Daniel Levitt, M.D., Ph.D. of CytRx.
“The Phase 1b/2 clinical results are exciting and highly supportive of the continued evaluation of INNO-206 as a first-line therapy in patients with advanced soft tissue sarcomas in CytRx’s ongoing international Phase 2b clinical trial,” stated Dr. Chawla. “These data are even more impressive given the advanced stage of disease of the trial patients and the fact that these patients had already either not responded to or relapsed after being treated with, on average, two prior therapies. Additionally the lack of cardiac toxicity thus far is significant, as this reduces the potential for cardiac safety issues that are associated with standard doxorubicin and limits its clinical efficacy. I was impressed by the progression-free survival of approximately 6.4 months, which is longer than the 4.4 month PFS seen with pazopanib treatment in a very similar patient population. Pazopanib, commercially known as Votrient, was recently approved by the FDA as a second-line treatment for soft tissue sarcomas.”
“These are powerful results in a very sick patient population. In light of the strength of these results and the fact that there are only limited approved therapies for patients with advanced soft tissue sarcomas, we plan to meet with the FDA to discuss a Phase 3 pivotal trial design with INNO-206 as a third-line therapy in soft tissue sarcoma patients,” said CytRx President and CEO Steven A. Kriegsman. “We have consulted with key thought leaders in the field of soft tissue sarcomas and are preparing a draft clinical trial protocol. If we get approval from the FDA to move forward with this trial, we believe it could be the pivotal study necessary to file for FDA marketing approval, allowing us to eliminate years from the traditional regulatory process.”
“CytRx holds exclusive worldwide rights to INNO-206, which is based on a proprietary linker technology that offers multiple potential benefits,” stated CytRx Chief Medical Officer Dr. Daniel Levitt. “This technology allows the agent to concentrate at tumor sites where the delivery molecule is cleaved and the drug, in this instance doxorubicin, is released. The ability to deliver substantially more of the agent directly to the tumor site could improve effectiveness. Further, the drug attached to the linker is inactive until it is cleaved. This occurs at the tumor site and only in one other organ, the bone marrow. Thus, INNO-206 avoids many of the side effects associated with systemic delivery of doxorubicin itself.”
Clinical Trial Background
The Phase 1b/2 clinical trial enrolled a total of 25 patients with advanced solid tumors, the majority of whom had advanced soft tissue sarcoma. These patients had either not responded to or relapsed after treatment with 1 to 3 prior chemotherapy regimens. The initial Phase 1b portion of the trial established the maximum tolerated dose of INNO-206 for this patient population at 350 mg/m2, which is equivalent to doxorubicin at 260 mg/m2, or approximate 3.5 times the typical dose (75 mg/m2) administered to patients with soft tissue sarcoma. Patients in the extended Phase 1b/2 trial were administered up to eight cycles of INNO-206 at the maximum tolerated dose in 21-day intervals.
For patients treated at the maximum tolerated dose, the most common grade 3 and 4 adverse events were hematological and included abnormally low neutrophil (white blood cell) counts, a decrease in platelet counts and worsening anemia. One grade 4 febrile neutropenia (fever accompanied with low levels of neutrophils) was reported, and grade 3 adverse events also included two patients with worsening hyponatremia (an electrolyte disturbance) and one patient with dehydration, all of which resolved prior to the start of the subsequent treatment cycle. None of these side effects were unexpected.
Soft Tissue Sarcoma
Each year in the U.S. nearly 11,000 new cases of soft tissue sarcoma are diagnosed and almost 4,000 deaths are reported due to this cancer. Patients with advanced soft tissue sarcoma who can no longer be treated with surgery and have relapsed or were refractory to prior chemotherapies have a poor prognosis, with fewer than 15% living past five years. CytRx has been granted orphan drug designation by the FDA for the treatment of patients with soft tissue sarcomas.
In addition to the Phase 1b/2 clinical trial, CytRx also is conducting a multicenter, international Phase 2b trial with INNO-206 as a first-line treatment for patients with advanced soft tissue sarcoma. This trial is designed to compare therapeutic treatment with INNO-206 head-to-head with doxorubicin with the goal of proving the superiority of INNO-206. Enrollment and analysis of the trial is expected to be completed in 2013. Dr. Chawla also is acting as principal investigator for this trial.
Other Indications
CytRx recently initiated a Phase 2 clinical trial evaluating the preliminary efficacy and safety of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas who have progressed after receiving two prior therapies. Daniel Von Hoff, M.D., Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute, is serving as the clinical trial's principal investigator. Some data from this trial could be reported as early as the end of 2012.
Investor Conference Call
CytRx will host an investor conference call accompanied by a slide presentation on Monday, June 4 at 10:00 a.m. Eastern time (7:00 a.m. Pacific time) featuring Dr. Chawla and CytRx management to discuss the clinical trial data and next steps for the INNO-206 program in soft tissue sarcoma. The slide presentation will be available on the homepage of the Company’s website www.cytrx.com. To access the conference call, dial (888) 463-4383 (U.S. and Canada) or (706) 679-5355 (international callers).
A webcast and the slide presentation also will be available on the Investor Relations section of the CytRx website. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international callers) and enter the conference ID number: 77958605.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes three programs in clinical development for cancer indications: INNO-206, tamibarotene and bafetinib. With its tumor-targeted doxorubicin conjugate INNO-206, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, and recently initiated a Phase 2 trial for patients with advanced pancreatic ductual adenocarcinomas. CytRx's pipeline also includes tamibarotene, which it is testing in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and which is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about the Company, visit www.cytrx.com.
Forward-Looking Statements

prisuttu

26 juin 2012 •18:33

belle réaction depuis le R/S
passée de 2.50 à 5.30
à suivre ligne presque verte àprès -60%

Profil supprimé

31 janvier 2013 •14:45

CytRx Receives Recommendation from Data Safety Monitoring Committee to Complete Global Phase 2b Clinical Trial with Tamibarotene as First-Line Treatment for Non-Small-Cell Lung Cancer

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that the Data Safety Monitoring Committee overseeing the Company’s global Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) has recommended conducting the clinical trial through completion. Enrollment of at least 140 evaluable patients is expected in the first quarter of 2013.


“The Committee’s recommendation indicates that no significant safety issues have been seen with tamibarotene in the international Phase 2b clinical trial as we near enrollment completion with tamibarotene’s use in combination with potent chemotherapy agents in patients with advanced NSCLC,” said CytRx CEO Steven A. Kriegsman. “We are one step closer to completing this important clinical trial and further assessing tamibarotene in a potential multibillion dollar market, which is a major priority for our Company and our shareholders.”

Subjects with stage IIIb or IV NSCLS who have not received prior non-adjuvant chemotherapy are being enrolled in the blinded, randomized clinical trial at sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Trial patients are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival and quality-of-life in this population, among other measures. The Data Safety Monitoring Committee is an independent group of oncologists and biostatisticians who monitor the safety and efficacy of the Phase 2b trial.

“Tamibarotene is an orally available, rationally designed, synthetic retinoid compound that is 10-times more potent than all-trans retinoic acid (ATRA) and was designed to avoid several side effects of ATRA,” said Daniel Levitt, MD, Ph.D., CytRx’s Executive Vice President and Chief Medical Officer. “This event is significant due to favorable results from a single-center clinical trial in patients with advanced NSCLC that compared treatment with ATRA added to a regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin alone. Patients who received the regimen with ATRA showed improved response rates of 55.8% versus 25.4%, increased progression-free survival of 8.9 months versus 6.0 months, and a 14-month median extension of life.”

CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of NSCLC, and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.

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11 décembre 2013 •15:56

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