Formatech reports that GeoVax Labs’ HIV/AIDS vaccine will be the first clinical candidate that is formulated and filled under its Fillanthropy Program. Formatech will aseptically fill and finish one lot of the vaccine for use in support of GeoVax’ upcoming clinical trials. The production run is scheduled to be completed in January 2010.
“This generous gift represents a substantial cost savings to GeoVax, and we graciously thank Formatech for helping the company work toward our goal of managing and preventing the spread of HIV/AIDS through the development of a vaccine,” remarks Robert McNally, Ph.D., president and CEO.
“As a thank you for this donation and in keeping with Formatech’s philosophy behind their program,” adds Dr. McNally, “GeoVax will contribute a portion of this savings to a HIV/AIDS charity to be named at a later date.
“The vials, which will contain our DNA vaccine, will be frozen and used with our future trials. This lot should allow us enough vaccine for upcoming preventative and therapeutic clinical trials.”
GeoVax’ HVTN 045 DNA vaccine has demonstrated safety in Phase I trials. Its HVTN 065 DNA and MVA vaccine is designed as a prime-boost regimen and has progressed into Phase II. Its lead clinical candidate, HVTN 205, entered a Phase IIa trial earlier this year.
Under Formatech’s Fillanthropy Program, each month beginning in January 2010, the firm will donate the services required to aseptically fill and finish one lot of drug product for selected therapeutic candidates that are entering clinical trials. To be eligible, companies must be developing a clinical candidate that is delivered as a sterile injectable product. Formatech says that when selecting a candidate it considers both the product’s potential therapeutic benefit and the financial need of the sponsor.
Formatech, founded in 1993 and based in Andover, MA, provides contract services related to product development and manufacturing challenges including preformulation/formulation development of all common dosage forms such as lyophilized dosage forms, cell culture/fermentation process development, and purification/downstream process optimization.
Its aseptic manufacturing facility produces liquid and lyophilized dosage units for clinical supplies or small-scale commercial products. Manufacturing support services include compounding/formulation, diafiltration/concentration, release testing, and full ICH guideline stability programs.