New ammunition against bird flu in the works [Part 2 of 2]
In the pipeline
Two NIAID-funded projects that Cornell’s Moscona finds exciting include Fludase, a new inhaled antiviral drug in development from San Diego firm NexBio that may be able to protect against any influenza virus entering a person’s respiratory system, and a new neuraminidase inhibitor from Biota, an Australian firm whose researchers developed Relenza. Patients would take the Biota drug just once or twice a week, instead of the daily doses that are needed for the current drugs in that class. NexBio says their drug could be ready for FDA submission by June of 2006; Biota’s product, isn’t expected before Fall of 2007.
Several other companies are moving along on research aimed at preventing and treating avian flu. Some products are already available, some are expected by Spring, and everyone is working at breakneck speed.
*Genaco Biomedical Products of Huntsville, Ala., has created a diagnostic test that can, using DNA, identify the avian flu within just four hours, instead of the several days it currently takes. That would allow health department labs to identify avian flu if it strikes, and put emergency plans into place. It would also allow the labs to do frequent tests on virus samples; if the virus changes, the types and doses of drugs can be adjusted. The test is in current use internally by the CDC, and Genaco expects to be selling the test equipment and materials shortly to both private and public laboratories.
*Research by Hemispherx Biopharma of Philadelphia is exploring whether its drug Ampligen can increase the immune response of Tamiflu, Relenza or avian flu vaccines. The company will be able to use data from human safety studies conducted to see if the drug is safe in patients for the treatment of chronic fatigue syndrome, and they have already started animal studies. Hemispherx CEO William A. Carter says the company could be ready to apply to the FDA for approval for treating avian flu by next January.
*Peramivir, a drug from BioCryst of Birmingham, Ala., is a neuraminidase inhibitor that may be able to be given as a one-time injection rather than in daily doses. According to McCamant, of the Medical Technology Stock Letter, approval and drug production could happen by early to mid-2006.
*AVI BioPharma, Inc., of Portland, Ore., has a novel drug in development called AVI-5706 that targets the part of the genetic code of the virus that allows it to replicate. The compound "acts like a staple across the zipper to keep it in place,’’ says Michael Hubbard, a company spokesman. By keeping the virus from reproducing, the company is able to reduce the amount of virus in the body, which would allow the body’s own immune response to kick in. The company expects to file for FDA approval as early as mid-2006.
*Medimmune of Gaithersburg, Md., is working with NIAID researchers on an avian flu vaccine that uses the company’s nasal spray technology, which is already available as a standard flu vaccine, FluMist. However, the company says it could take years before the they know if the vaccine is effective.
*Powdermed, based in Oxford, England, has a novel vaccine technology that uses recombinant bacteria rather than eggs to grow the vaccine. The vaccine is embedded in gold particles and delivered via a high-pressured system applied to the skin, and people may be able to give the vaccine to themselves. Although the company is heavily engaged in clinical trials, and could ramp up a vaccine in three months once the strain is identified — that’s half the time needed for egg culture vaccines — they recently announced that they won’t have the manufacturing facility for the device needed to deliver the vaccine completed before April 2007.
With all this fast-paced development, the FDA has promised to step on the gas once the applications reach their offices, and has formed a "rapid response team" to help with the approval and availability of vaccines and drugs for avian flu.
While approval times for drugs generally take months or years, Dr. Andrew von Eschenbach, acting FDA commissioner, is far more optimistic about avian flu products.
"We believe,’’ says the commissioner, "[that] we could review a complete drug application [for these products] in six to eight weeks.’’
© 2005 MSNBC Interactive
msnbc.msn.com
MORE articles at site for those interested...
• Health experts unveil $1 billion bird flu plan
• NBC: Pandemic flu threat real
• U.S. to test bird-flu vaccine supplies
• New ammo against bird flu in the works
• Vietnam confirms 42nd bird flu death
• Poultry industry faces huge impact
• WHO: Nations need to test pandemic plans
• Bird flu questions and answers
• Beijing closes live poultry markets
• Roche to ramp up Tamiflu production
• Bird Flu Section Front |
