A local biotechnology company has received more federal funding to develop vaccines to combat not only seasonal flu, but a deadly strain of Avian flu.DynPort Vaccine Co., a Frederick company, and Baxter International, based in the Chicago suburb of Deerfield, Ill., have received $201.2 million from the U.S. Department of Health and Human Services for continued development of Baxter's seasonal and pandemic flu candidate vaccines.
The grant completes funding of a $242.5 million contract announced May 4, 2006, said April Finnen, a DynPort spokeswoman.
DynPort develops pharmaceutical products for the federal government. The company is a subsidiary of Computer Sciences Corp. in El Segundo, Calif., which provides information technology and biotechnology services.
Baxter is a global healthcare company with 45,000 employees and $10.4 billion in sales in 2006, according to the company's website.
Wayne Hockmeyer, founder and former chairman and CEO of MedImmune, is a member of Baxter's Board of Directors.
DynPort is the prime contractor and provides overall management of the clinical trials, according to a DVC release.
Baxter is developing the candidate vaccines, and will manufacture them and own all clinical data and licenses.
The pandemic research is targeting the highly pathogenic H5N1 Avian flu virus.
In November 2005, Avian flu was confirmed in 16 countries, according to 2006 report to Congress from the Department of Health and Human Services.
By March 2006, the virus had spread to 37 countries on three continents, according to the report.
H5N1 is evolving, and there are two main variants: Clade 1 and Clade 2, which is the newer, deadlier form of the virus that has spread to western Asia, Europe, the Middle East and Africa, according to the pandemic update.
The Clade 2 variant has killed 60 percent of those known to have been infected.
Baxter researchers are using a variety of H5N1 strains in vaccine development, said Christopher Bona, a Baxter spokesman.
"Even though H5N1 is evolving, we believe our ability to work with multiple strains will enable us to create a vaccine if a new strain develops," Bona said.
The outbreak of H5N1 is particularly deadly in Indonesia, Bona said.
According to a 2006 World Health Organization report, 113 cases of H5N1 have developed in Indonesia, 91 fatal.
The DVC-Baxter contract will fund development of a pandemic vaccine through Food and Drug Administration Phase 2 clinical trials for adults and Phase 1 trials for children, according to the DVC release.
The companies also plan to enroll U.S. patients in 2008 in a Phase 1 clinical trial for a pandemic flu vaccine candidate, according to the DVC release.
Phase 1 includes a small number of volunteers, between 20 and 80, according to the FDA. The first phase assesses dosage, how the drug is metabolized and excreted, and side effects.
The second expands the number of participants to about 100 to 300. Researchers gather more safety data and preliminary evidence of benefits.
The DVC-Baxter contract also funds USDA licensing of a seasonal flu vaccine that is a variant of the current seasonal flu vaccine.
"Because this vaccine is produced from cell cultures, those allergic to the normal egg-based flu vaccine will be able to use this one," Finnen said.
Cell cultures are living cells that are maintained outside a living organism in an artificial media of serum and nutrients.
The clinical portion of Phase 1 and 2 trials for a seasonal flu vaccine candidate was completed in July in Europe, according to the DVC release.
Preliminary data indicate that the vaccine induced strong antibody responses, and all study populations tolerated the vaccine well, according to the DVC release.
DVC and Baxter on Nov. 26 conducted a Phase 3 trial of a seasonal vaccine candidate on the first healthy adult volunteers in the U.S.
The third phase tests about 1,000 to 3,000 people for effectiveness and side effects, according to the USDA.
The final results from the Phase 3 trial will be available about a year from now, Finnen said.
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