I'd swear there used to be a thread for VaxGen, but the SI search engine, as if in harmony with the company's delisting, can't find it.
>>BRISBANE, Calif., Sept. 7 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Pink Sheets: VXGN.PK - News) announced today that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for the company's candidate smallpox vaccine, LC16m8.
The effective IND will allow VaxGen to begin clinical development of LC16m8 with the objective of meeting the U.S. government's stated interest in acquiring an emergency stockpile of an attenuated smallpox vaccine(1) and licensing the product for commercial sales. The U.S. government has indicated that it anticipates spending $1.9 billion to establish and maintain a stockpile of attenuated smallpox vaccine over a 10-year period.
The IND clears the way for a Phase I/II human clinical trial to evaluate the safety and immunogenicity of LC16m8 and compare it to Dryvax®, the smallpox vaccine currently licensed for use in the United States. The trial is expected to begin before the end of this year. It will involve approximately 150 volunteers at four leading medical centers: Saint Louis University Health Sciences Center, Stanford University, University of Kentucky and Vanderbilt University Medical Center.
"LC16m8 was extensively evaluated during its development in Japan and has a strong track record of safety," said Lance K. Gordon, Ph.D., VaxGen's president and chief executive officer. "The clinical trial we plan to initiate is part of the process required by the FDA to license LC16m8 for use in the United States. We believe this trial also will provide the U.S. government and other potential customers with important data to determine the best choice of attenuated smallpox vaccines for their biodefense needs."
Achieving FDA approval for LC16m8 will depend on the results of current and planned trials designed to satisfy FDA requirements for vaccine licensure.
About LC16m8
VaxGen is developing LC16m8 in the United States in partnership with the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) of Kumamoto, Japan. The vaccine was initially developed in Japan to address the need for a smallpox vaccine that was safer but as effective as conventional, unattenuated smallpox vaccines. Studies involving approximately 50,000 children were conducted in Japan, where the vaccine is currently licensed and manufactured commercially.
LC16m8 is produced in cell culture from vaccinia virus that has been attenuated, or modified, to reduce its potential to cause unwanted side effects.
LC16m8 has been shown to be less neurovirulent than unattenuated strains of vaccinia in animal models(2). Additionally, studies presented at the 7th Annual Conference on Vaccine Research sponsored by the National Foundation for Infectious Diseases in May 2004 demonstrated that LC16m8 provided 100% protection against poxvirus infection in both rabbits(3) and mice(4).
About the Phase I/II Clinical Trial of LC16m8
The 150 volunteers will be randomized 4:1, with 120 receiving LC16m8 and 30 receiving Dryvax. Study volunteers will be screened carefully for safety risk factors prior to enrollment. The screening process includes a physician's assessment of the volunteer's medical history, a physical exam, and a panel of cardiac and laboratory tests. All study volunteers will continue to be evaluated for safety in the clinic after vaccination and will return for regular safety assessments throughout the study. No one will be exposed to smallpox as a part of the clinical study.<<
Trades at about $10 on the pink sheets, and was recently upgraded by Punk, Ziegel. Not bad for a delisted stock! I'm not as sanguine about terrorism as that Canadian dude cited by BulbaMan over on your thread. If you bought into that rationale, you'd short anything terror-related, especially bioterror stocks. But a small gang of fanatics, adequately funded and supported, can do plenty of damage, as has been demonstrated on 9/11, Oklahoma, etc.
Cheers, Tuck |
