Profectus BioSciences Awarded $21.6 Million in NIH Contracts to Develop a HIV Preventative and a HIV Therapeutic Vaccine Business Wire
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Profectus BioSciences Awarded $21.6 Million in NIH Contracts to Develop a HIV Preventative and a HIV Therapeutic Vaccine

Business Wire - December 8, 2008


BALTIMORE--Profectus BioSciences, Inc. (Profectus), a biopharmaceutical company that develops proprietary prime/boost vaccines and small molecule to treat and prevent viral infections and cancers, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH) has awarded to Profectus via a Novation Agreement, two contracts (HHSN272200800061C and HHSN272200800062C) totaling $21.6 million to develop a preventative HIV vaccine delivered with the Company's recombinant vesicular stomatitis virus (rVSV) vector and a therapeutic HIV DNA based vaccine. The contracts were awarded to Profectus under NIAID's HIV Vaccine Design and Development Teams program.

The HIV preventative contract titled, HIV-1 Vaccine Candidates Delivered by VSV Vectors, provides funding for the Company to complete IND-enabling toxicology studies, cGMP-manufacturing of the company's prototype HIV rVSV vaccine and the conduct of a Phase I human clinical trial projected to begin in late 2009.

The HIV therapeutic contract titled, Therapeutic Immunization Against HIV with Adjuvant-enhanced DNA and Multi-epitope Peptide Vaccines, provides funding for the Company to complete the proposed development program, preclinical optimization, immunogenicity and challenge studies in animal models, IND-enabling toxicology studies, cGMP-manufacturing of all components of the DNA vaccine and the conduct of a Phase I human clinical trial projected to begin in late 2009.

Both contracts continue development of vaccines recently licensed to Profectus from Wyeth Pharmaceuticals under an Assignment and License Agreement (see Profectus announcement dated November 10, 2008).

"We believe that combining the recently licensed technologies around DNA vaccines, molecular adjuvants, and rVSV as a delivery vector coupled with the novel HIV envelope construct previously licensed to the Company from the Institute of Human Virology provides Profectus with the broadest platform in HIV vaccine development in the industry," said Profectus CEO & President Shawn Patrick O'Brien. "Our ability to deliver novel HIV immunogens delivered via DNA and boosted with rVSV sets us apart."

John Eldridge, Ph.D., Chief Scientific Officer, Vaccines (CSO) and Principal Investigator for both contracts oversees the research being done at Profectus for the expanded vaccine portfolio. Dr. Eldridge is a well-established investigator in this field since the late 1980's. While at Wyeth Vaccines, he was the HIV program champion and his efforts led to the original NIH contract funding that formed the nucleus of the research team currently in place at Profectus. Dr. Eldridge and the team have more than 150 years of combined experience in researching and delivering vaccines to the market.

"Profectus has demonstrated a significant amount of successes recently," said Don Caldwell, Chairman of the Board of Profectus and CEO of Cross Atlantic Capital Partners. "This is a testament to Shawn and the highly-respected team of scientists that has been brought together at Profectus."

The Profectus approach combines its rVSV and pDNA platforms via a unique prime boost strategy to advance vaccine research. Profectus addresses HIV, Hepatitis C Virus (HCV), Human Papilloma Virus (HPV) and Herpes Simplex Virus (HSV).

Prior to these contracts, Profectus has received over $15 Million in funding from multiple sources including NIH, Cross Atlantic Capital Partners and through private investments. Profectus deploys these resources in support of its proprietary prime/boost vaccines and its anti-inflammatory small molecules for cancer and chronic viral diseases.

About Profectus BioSciences Inc.

Profectus Biosciences is an R&D company dedicated to harnessing the immune system to prevent and treat chronic viral diseases and cancers through the delivery of proprietary prime/boost vaccines and small molecules. Profectus BioSciences Inc. commenced operations in early 2005. For more information please visit: www.profectusbiosciences.com.

Contacts

Media: Profectus BioSciences | Jeff Meshulam, 443-743-1107 | meshulam@profectusbiosciences.com

or

Garfield Group Public Relations | Christian Barbato, 215-867-8600 (x227) | cbarbato@garfieldgroup.com


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