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16 Feb 2006 21:53 GMT 2ND UPDATE: Hemispherx: Ampligen Drug Can Be Used For Avian Flu




By Val Brickates Kennedy


BOSTON (Dow Jones) -- Hemispherx unveiled medical data Thursday that showed its anti-viral drug Ampligen can be highly effective in boosting the power of the avian flu-fighting drugs Tamiflu and Relenza, and avian flu vaccines.


Shares of Hemispherx (HEB) closed up 11% at $2.94 on Thursday.


Hemispherx said it plans to formally present the data Thursday afternoon at the fourth annual Biodefense Research Meeting of the American Society of Microbiology being held in Washington, D.C. The studies were conducted in conjunction with the National Institute of Infectious Diseases of Japan.


In a recent interview, Hemispherx chief executive officer Dr. William Carter said Ampligen can greatly boost the effectiveness of Roche's Tamiflu and GlaxoSmithKline's (GSK) Relenza, two leading anti-virals that governments have been rushing to stockpile as a hedge against the deadly illness.


The drug also shows promise in strengthening the power of various avian flu vaccines currently under development. By bolstering the drugs' effectiveness, he said, doctors would also be able to greatly stretch the supply of the medicines.


"You could take a supply for 4 million people and make it a supply for several hundred million people," said Hemispherx chief executive officer Dr. William Carter, using Relenza as an example. Carter added that data showed small amounts of Ampligen could enhance the effectiveness of Relenza by 300 to 500 times, and Tamiflu by 100 times.


World health experts have predicted that a virulent strain of avian flu, called H5N1, may eventually mutate into a virus that is easily transmitted among humans. Health experts have warned that such a mutation could trigger a worldwide flu pandemic, killing millions. Governments have responded by stockpiling Tamiflu and, to a lesser extent, Relenza, while pushing to develop effective vaccines.


Ampligen is currently in Phase III clinical testing for chronic fatigue syndrome. However, Carter said the product could be quickly put to use in a pandemic situation under the FDA's emergency use clause, which allows for certain drugs to be used in the field if they have already been tested for safety in humans.


At this point, world health experts believe that Tamiflu is far more effective in treating avian flu than Relenza. However, confidence in Tamiflu has been somewhat undermined by recent reports from Asian doctors in the field was largely ineffective in treating some victims of the virus.


Another issue has been dosing. Many medical experts have theorized that Tamiflu's current recommended dose may be too low to combat such a powerful virus. But increasing dosages would only serve to constrain an already tight supply of the drug worldwide.


By adding Ampligen, said Carter, Tamiflu's strength could be boosted by up to 100 times.


In addition, according to Carter, about 18% of all individuals are naturally resistant to Tamiflu, while others can develop a resistance after time. Eventually, the flu virus would mutate to also become more resistant to the drug.


Carter said that some of these resistance issues could also be mitigated by adding "trace amounts" Ampligen to the mix.


"The magnitude of this improved efficacy is such that it would overcome the resistance," said Carter. "This phenomenon of efficacy also extends to the vaccines."


Hemispherx's data shows that Ampligen can also extend the effectiveness of some of the vaccines being developed by about 100 times.


That enhancement could serve as a hedge against the virus' inevitable mutation. As time goes on, flu viruses invariably mutate, rendering many of the vaccines developed to combat them obsolete.


"When a virus is country hopping as it migrates, it's also genetically moving and mutating," said Carter. "The 100 times number means you may still have an effective vaccine as the virus mutates."


Carter also asserted that even when used alone, Ampligen could help improve victims' chances for survival. According to a recent laboratory study, animals infected with the human flu strain had a two to three times better chance of surviving if they received Ampligen, he said.


In order to make the drug more user-friendly in a chaotic, pandemic setting, Hemispherx has been developing a formula that can be inhaled through the nose. The drug can also be conveniently stored at room-temperature. Currently, the drug is delivered via injection.


The company is able to currently produce up to 100 million doses a year at its New Brunswick, N.J., plant, Hemispherx said.


Hemispherx will also present Phase 1/II clinical data later today on its interferon drug Alferon LDO, which is already on the market to treat sexually transmitted diseases. The drug boosts the body's levels of interferon, a key component of the immune system.


According to the data, said Carter, Alferon, may be able to improve the chances of surviving the virus by strengthening the immune system.


Carter said he hoped that Thursday's data will garner the company more attention as governments rush to beef up their avian flu drug stockpiles.


"We're in active discussions with different government entities to see if we can contribute to the stockpiling," said Carter.