Hemispherx Biopharma’s Influenza Results

It’s very unfortunate Dr. Hasegawa wasn’t able to attend the Annual Conference of the Japanese Society For Vaccinology held in Sapporo, Japan on September 27, 2009. Although an abstract was published on the Hemispherx website, we feel as if the investment community only glanced over the presentation. To help us clarify the abstract, we had a conference call this week with Dr. Carter, Hemispherx Biopharma’s (HEB – $1.88) chairman and CEO.

The fact that vaccines against swine flu are being developed, manufactured and will be ready when the flu season starts is correct. The fact that Hemispherx’ experimental drug Ampligen would therefore become unnecessary, is absolutely not correct.

See the problem with flu viruses is that they tend to mutate. We’ve seen this happen with the avian flu a few years ago when the US Department of Health & Human Services (HHS) ordered millions of doses of avian influenza vaccines. Once the vaccines were manufactured, they turned out only to be useful against the virus strain that was active in Vietnam. This was due to the fact that companies like Aventis Pasteur developed a vaccine based on a virus that was active a few months before. In the meanwhile the virus had mutated and the “old” vaccine had lost its efficacy.

The big question is if the currently developed swine flu vaccines are going to be useful against mutated virus strains as well. The vaccine’s efficacy is dependent on the virus remaining the same. And if the virus mutates genetically, like studies in Brazil have already established, the current vaccines may lose some or all of their activity.

That’s where Dr. Hasegawa’s study on monkeys comes into play. He found that when Ampligen is co-administered with the seasonal influenza vaccine, it produces such a robust immune response that it even protects against a pandemic virus. So if we should see a even more aggressive mutation of the swine flu virus in the coming months, it may create a significant need for a product like Ampligen.

What’s next?

Dr. Hasegawa will initiate studies in Japan by the end of this or early next year on 100 to 200 healthy volunteers. Those volunteers will be given two doses of regular flu vaccine and Ampligen about three weeks apart. Next, those volunteers will be studied for 2 to 3 months to establish if the same pattern of antibody production, safety and tolerability is seen as in the monkey study.

Remember that when you’re dealing with a pandemic disease, you don’t have to show therapeutic benefit, only serological, or laboratory, benefit. So if anyone wonders why HEB has recently taken steps to significantly increase its manufacturing capabilities, this may be a good answer.

It’s also important to notice that Dr. Hasegawa will only test Ampligen as he feels this is the most promising product and that these test will be paid by the Japanese Ministry of Health.

Dr. Hasegawa’s Study

Dr. Hasegawa’s results may be published in a scientific journal, but we also found he’s scheduled to present at a conference is Osaka on October 10th. It hasn’t been confirmed that he will be presenting this data, but it would be a nice coincidence as Biken, the corporate arm of the university of Osaka and the licensee of Ampligen in Japan, is headquartered in Osaka.

We hope to see these results published soon as they may trigger some serious attention.

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