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US42366C5094 HEB

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HEMISPHERX BIO : les news de Dianne

16 déc. 201315:41

Centers for Disease Control Urges Preparation for an Active Seasonal Flu Season

Hemispherx Biopharma Accelerates Program to Evaluate Ampligen®/FluMist® Combination as Potential Intranasal Influenza Vaccine Against Pandemic Flu Strains

PHILADELPHIA, December 16, 2013 -- Hemispherx Biopharma, Inc.(NYSE MKT:HEB) (the "Company" or "Hemispherx") announced that the company will accelerate its experimental program for a new intranasal influenza vaccine combination following a media briefing by the Centers for Disease Control (CDC) urging Americans, especially young children and the elderly, to get vaccinated for the emerging flu season immediately (CDC, December 12, 2013), coincidental with National Influenza Vaccination Week.

According to the CDC, Flu vaccination prevented an estimated 6.6 million influenza-associated illnesses, 3.2 million medically attended illnesses, and 79,000 hospitalizations during the 2012-2013 flu season,” as reported in the Morbidity and Mortality Weekly Report (MMWR). "CDC also reported today that despite the benefits of flu vaccination, only 40% of Americans 6 months and older had reported getting a flu vaccine this season as of early November 2013.”

"The estimated benefits of vaccination for the 2012-2013 season are higher than any other season for which CDC has produced similar estimates. These high numbers are attributable to the severity of the season. The report estimates that last season there were a total of 31.8 million influenza-associated illnesses, 14.4 medically attended illnesses, and 381,000 hospitalizations in the United States.”

The CDC also reported that children have already died from the flu this season. While the current approved vaccines are not completely effective against all known seasonal influenza strains, officials said they wouldn’t know the effectiveness of the current seasonal vaccines until flu season ends.

Hemispherx recently announced that its Phase 1/2 clinical trial at the University of Alabama Vaccine Research Clinic of intranasally administered Ampligen ® and FluMist ® is now being expanded based on an analysis of safety results to date conducted by both the Food and Drug Administration ("FDA") and a Data Monitoring Committee, the latter group comprised of a team of independent clinical, basic research, and statistical professionals. Ampligen® is an experimental immunotherapeutic and FluMist® is a live attenuated seasonal influenza vaccine.

FluMist®, the only commercially available seasonal influenza vaccine available in the USA for intranasal use, was approved by the FDA in 2003. Given alone, it has (as expected) no known activity against any strains of pandemic influenza. With respect to efficacy in its primary target population (adults age 18-49), FluMist® (given alone) only reduces the febrile illness occurrence rate from 10.9 to 23.7% over placebo treatment (Belshe R et al. 2004, CID 39:920-927). In another study of FluMist intranasal vaccination, 9% of the treated group had a 4-fold or greater increase in the accepted therapeutic surrogate endpoint in serum called "HAI”, while thirty-three percent of treated subjects increased potentially protective antibody (IgA) in the nose (Barria M, et al. 2013, JID 207 (1): 115-124 ). Going forward, new experiments ongoing at the University of Alabama are designed to test in populations of healthy young volunteers whether FluMist® administered with Ampligen® can dramatically increase the percentage of responders.

The ongoing clinical study is the first extension to humans of preclinical studies, previously published in the peer-reviewed literature, indicating that the combination of Ampligen® (an experimental therapeutic) with commercially available seasonal influenza vaccine when applied intranasally, may provide enhanced protection against certain potentially pandemic influenza strains (Ichinohe T, et al. 2007, JID 196:1313-1320).

It is hoped that FluMist® combined with an effective immune adjuvant may be able to provide easily administered protection in humans even against mutated strains of flu virus including both H7N9 and H5N1 strains (please see Hemispherx release dated December 9, 2013). Successful enhancement of immune responses in the current study group of young adults by Ampligen®, an experimental therapeutic, would provide justification for extension of studies to the elderly who, as a group, could benefit greatly from more effective vaccines.Avian H5N1 and H7N9 viruses are highly pathogenic in humans. Human disease has been limited thus far by the inability of these viruses to infect the upper airways of humans – although there has been concern that viral mutations could provide this capacity. The Company believes that the expanded human trial at the University of Alabama will provide the first data in humans as to whether the epitope expansion observed by Dr. Hasegawa in experimental animals occurs in humans. Successful animal experimentation does not necessarily predict clinical effectiveness and no assurance can be given that the projected clinical tests will demonstrate either acceptable safety or efficacy.

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