NABI BIOPHARMACEUTICALS : OPXA

drenan

11 mai 2010 •15:32

Opexa Strengthens Tovaxin® Patent Estate Through Issuance of Key Patents

Two Key T-cell Patents Issued, One Notice of Allowance Received

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a personalized T-cell therapy for multiple sclerosis (MS), announced today that two of its key patents have been issued by the U.S. Patent and Trademark Office, with a third patent expected to issue later this month based on a received Notice of Allowance. These issued and allowed patents strengthen the Opexa patent estate related to its T-cell vaccine franchise.

“Our T-cell technology is the backbone of the Tovaxin development program which is in late clinical development for the treatment of MS. We view intellectual property protection as critical for maintaining and enhancing our long term competitive position”

The newly issued patents are U.S. Patent Nos. 7,695,713 and 7,658,926, the granted claims of which are directed to Opexa’s proprietary process for manufacturing its T-cell vaccines as well as to compositions of such vaccines having reactivity to critical MS antigens. Additionally, a Notice of Allowance has also been received for Opexa’s U.S. Patent Application Serial No. 10/520,296, which is directed to T-cell vaccines based on autoreactive T-cell receptor epitopes found in a significant percentage of MS patients.

“Strengthening our patent position in the area of T-cell technology has been a key objective for us over the past twelve months and is strategically important for Opexa’s long term value,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “Our T-cell technology is the backbone of the Tovaxin development program which is in late clinical development for the treatment of MS. We view intellectual property protection as critical for maintaining and enhancing our long term competitive position,” added Mr. Warma.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company’s leading therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in clinical development for multiple sclerosis (MS). Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

Opexa completed its 150 patient Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase 2b clinical study in late 2008 which was one of the first clinical studies investigating an autologous T-cell therapy in MS patients. Data from this clinical study show evidence that Relapsing Remitting MS (RRMS) patients treated with Tovaxin saw overall clinical, MRI, and immunological benefits over the placebo group, including statistical significance for decrease in the Annualized Relapse Rate (ARR), improvement in disability score (EDSS), and improvement in quality of life measures (MSQLI), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,” “intends,” and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial payments, returns, royalties, performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: market conditions, our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company's product candidate, Tovaxin, on reasonably satisfactory terms (if at all), and our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights transferred by the Company, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in the reports filed with the Securities and Exchange Commission.

Profil supprimé

18 octobre 2011 •20:16

et oui ! il la veut son OPA aussi mon doudou et il sait qu'OPXA est un très bon candidat...

j'espère que tu vas bien mon doudou et que tu l'auras aussi ton OPA, tu la mérites vraiment...

drenan

18 octobre 2011 •21:01

mon OPA cette année, c'était avec OPEC ... tellement inoubliable que je me souviens à peine de la prime : 15 % je crois ... ! de la pure folie !!;-)

Si y a bien qqu'un qui la mérite sur ce forum l'OPA, c bien toi ! Arrose ça bien avec la lituanienne ... demande lui de ramener qq copines du pays ! ;-))

Profil supprimé

18 octobre 2011 •21:15

véritable orgie avec tutu , je ne sais même pas si sa pv sur ANDS suffira ;-)))

pour en revenir à ANDS , il me semble que la semaine dernière il y avait quelques échanges copieux , je serais curieux de savoir quel initié a ramassé ces titres...
c'est Wellington ( le vendeur ? )qui doit se les bouffer...

prisuttu

19 octobre 2011 •05:45

in 1.11$
depuis le temps que je doit rentrer sur celle là ....
Je vais pas laisser david se gaver d'OPA tout seul lol !!!!!!
sasane prépare ton "loup" et ton petit short en cuir pour la soirée " ANDS" ....

Profil supprimé

04 novembre 2011 •13:43

http://www.bioportfolio.com/news/article/853213/Opexa-Therapeutics-Reports-Third -Quarter-2011-Financial-Results-And-Provides-Corporate-Update.html

Opexa Therapeutics Reports Third Quarter 2011 Financial Results and Provides Corporate Update
4th of November 2011 @ 08:30 |

{Businesswire via BioPortfolio}

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended September 30, 2011 and provided an overview of recent corporate developments.

Recent highlights include:

Electing Gail J. Maderis, a seasoned pharmaceutical executive with a strong track record of leading biopharma companies through the clinical development stage, to Opexa’s Board of Directors, thereby strengthening the Company’s oversight to execute on its key strategic initiatives;
Appointing Mark Freedman, M.D., a leading worldwide expert in MS, to Opexa’s highly esteemed Scientific Advisory Board; and
Advancing the clinical plans for Tovaxin and defining a clinical trial protocol for Secondary Progressive MS.

“Much progress was made in further advancing our plans and discussions in the area of Secondary Progressive MS,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “We know that this population of MS patients is greatly underserved with only one drug currently approved by the FDA specifically for Secondary Progressive MS. Our focus has been on further clarifying Tovaxin’s potential in SPMS through discussions with key opinion leaders, patients and pharmaceutical companies. We have treated numerous patients with Secondary Progressive MS in previous clinical trials. The data appears encouraging and safety is superb, as it has been for all Tovaxin clinical trials, and the unmet need remains significant. Consequently, this disease area remains a high priority for Opexa.”

“To prepare for the next clinical trial with Tovaxin, we have remained on schedule with respect to the implementation of manufacturing and clinical priorities. Hiring of key staff has proceeded according to plan and we have appointed very strong individuals in the areas of Manufacturing, Quality Control and Quality Assurance. I am very pleased with this progress.”

“In addition to augmenting our staff with excellent individuals, we have significantly strengthened our Scientific Advisory Board through the appointment of Dr. Mark Freedman, M.D. and our Board of Directors with the appointment of Gail Maderis. Dr. Freedman is one of the world’s leading experts in MS and will be invaluable as we move into the next clinical trial with Tovaxin. Ms. Maderis spent years as a senior pharmaceutical executive previously at Genzyme and also developed strong expertise in the industry as a biotech entrepreneur and CEO and brings a wealth of experience to the Board. We are grateful for their support and guidance.”

“As of September 30, 2011, our cash and cash equivalents totaled approximately $8.6 million and our current monthly burn rate was approximately $450,000,” continued Mr. Warma. “At the current burn rate, we should have sufficient capital to support our operations at their current level through 2012. Moving forward, we expect to maintain our focus on implementing operational steps in anticipation of continuing the clinical study of Tovaxin and working to secure the necessary resources to support such a study.”

Third Quarter Financial Results

Opexa reported no commercial revenues in the three and nine months ended September 30, 2011 or in the comparable prior-year periods.

Research and development expenses were $654,772 and $2,194,141 for the three and nine months ended September 30, 2011, respectively, compared with $625,282 and $2,193,919 for the three and nine months ended September 30, 2010, respectively. The increase for the three months ended September 30, 2011 compared to the three months ended September 30, 2010 was due to increased staff associated with development activities and an increase in associated laboratory costs and supplies, and was partially offset by a decrease in the engagement of consultants.

General and administrative expenses for the three and nine months ended September 30, 2011 were $584,794 and $1,737,686, respectively, compared with $626,697 and $1,706,546 for the three and nine months ended September 30, 2010, respectively. The decrease for the three months ended September 30, 2011 compared to the three months ended September 30, 2010 was due to a decrease in compensation expense, and was partially offset by an increase in business development expenses. The increase for the nine months ended September 30, 2011 compared to the nine months ended September 30, 2010 was due to an increase in costs related to business development expenses, increased investor relations outreach costs and an increase in stock compensation expense, and was partially offset by a decrease in legal costs.

Depreciation and amortization expense for the three and nine months ended September 30, 2011 was $56,888 and $157,254, respectively, compared with $37,647 and $136,022 for the three and nine months ended September 30, 2010, respectively. The increase was due to an increase in depreciation for facility buildout costs incurred during 2011, an increase in depreciation for laboratory and manufacturing equipment acquired during 2011 and an increase in depreciation for information technology equipment to replace and upgrade obsolete equipment.

Interest expense for the three and nine months ended September 30, 2011 was $638 and $2,643, respectively, compared with $2,004 and $499,200 for the three and nine months ended September 30, 2010, respectively. The decrease in expense for the nine months ended September 30, 2011 compared to the nine months ended September 30, 2010 was primarily related to the amortized interest incurred during the first half of 2010 and the amortization of the remaining discount and deferred financing fees in conjunction with the June 23, 2010 conversion of the 10% Convertible Promissory Notes.

Opexa reported a net loss for the three months ended September 30, 2011 of $1.30 million, or ($0.06) per share, and a net loss for the nine months ended September 30, 2011 of $4.09 million, or ($0.18) per share. For the same three month and nine month periods ending September 30, 2010, Opexa reported a net loss of $1.29 million, or ($0.07) per share, and $4.53 million, or ($0.27) per share, respectively.

Cash and cash equivalents were $8,639,856 as of September 30, 2011 compared to $4,733,445 as of September 30, 2010.

Further details can be found in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS). The Company’s leading therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in late stage clinical development for MS. Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com.

prisuttu

08 novembre 2011 •14:49

http://www.marketwatch.com/story/opexas-tovaxinr-for-the-treatment-of-multiple-s clerosis-granted-fast-track-designation-by-fda-2011-11-08

Profil supprimé

08 novembre 2011 •15:11

1.38 en prémarket (51 000 titres échangés) et un plus haut à 1.60

pourvu que ça dure ;-)

Profil supprimé

08 novembre 2011 •15:24

alors si tu peux sortir à bon compte aujourd'hui ... mais tu risques aussi d'avoir des regrets car AK ou partenariat ? telle est la question ...

drenan

08 novembre 2011 •15:33

de toute façon ;-)

Profil supprimé

08 novembre 2011 •16:17

tu pointes ou tu tires ?

Profil supprimé

08 novembre 2011 •16:59

tu veux la vendre à 1.69 , hein coquine ?

prisuttu

08 novembre 2011 •17:10

hummmmmm

prisuttu

14 novembre 2011 •15:53

Opexa Announces Publication in Multiple Sclerosis Journal of Tovaxin® Phase IIb Clinical Trial Results

Press Release: Opexa Therapeutics, Inc. – 1 hour 22 minutes ago

Email
Print
Companies:
Opexa Therapeutics, Inc.
RELATED QUOTES
Symbol Price Change
OPXA 1.3899 +0.09

THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that results of the Company’s prior Phase IIb clinical trial of Tovaxin have been published in a leading peer-reviewed publication, Multiple Sclerosis Journal.
The Phase IIb placebo-controlled study [Tovaxin for Early Relapsing Multiple Sclerosis (TERMS)] was conducted in 150 patients, evaluating safety and efficacy of Tovaxin in relapsing-remitting MS patients (RRMS) and those with clinically isolated syndrome. The TERMS study, first reported in 2008, showed that Tovaxin was well-tolerated, with no serious adverse events, and demonstrated encouraging clinical results in the reduction of the annualized relapse rate (ARR) and improvement in disease progression.
“The TERMS trial was a landmark study in that it was the first time that a personalized immunotherapy of this nature was used to treat MS patients,” commented Edward Fox, MD, PhD, director of the MS Clinical of Central Texas, and a principal investigator in the TERMS study. “The results were encouraging in that they supported the continued development of Tovaxin in both relapsing remitting and secondary progressive MS.”
“The data from the TERMS study were important for a number of reasons, including demonstrating a strong safety profile and supportive efficacy findings,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “Furthermore, the sub-population analyses were critical to increasing our understanding of the mechanism of action of Tovaxin. The sub-population of patients with more active disease – those with a baseline ARR greater than 1 – demonstrated a benefit for Tovaxin in terms of annualized relapse rate and disability progression, with many of these patients showing an improvement in their disability. We believe that we can draw important parallels from this group to those patients we will be targeting for our secondary progressive MS (SPMS) clinical program. We are currently preparing for a Phase IIb clinical trial of Tovaxin in SPMS, once we secure the necessary funding, as we have just received Fast Track designation from the U.S. FDA for SPMS.”
The article, “A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trials design,” was published electronically ahead of print in OnlineFirst at http://msj.sagepub.com/content/early/2011/11/07/1352458511428462.full.pdf+html, and will be available through Open Access in a future edition of Multiple Sclerosis Journal.
About Opexa

prisuttu

13 juillet 2012 •21:36

et oui j'en rajoute une couche au sujet de "maitre" david !!
la gamine il l' a suit depuis longtemps !!
faut le suivre le " david " merci à lui de nous informer de ses" trades "
je l'ai souvent suivit avec succès !!le seul inconvénient c'est que david c'est du "jean paul belmondo " : "tac tac j'achète une roulade une cascade et je vend " et moi c'est plutot cool raoul mais bon au final je m'en sors plutot pas mal en le suivant.
voilà david petit hommage ( prend pas le melon non plus lol)

la lituanienne

drenan

16 juillet 2012 •15:14

genre de gamines :)