Pharmexa A/S (DK) - Promising clinical results from new HIV vaccine
Summary: Promising preliminary safety and immune response results from the HVTN 064 trial of a Pharmexa HIV vaccine presented at HIV Vaccine Trials Network meeting
HØRSHOLM, Denmark, Nov. 9, 2007-At the fall meeting of the HIV Vaccine Trials Network, Pharmexa today announced preliminary results from the HVTN 064 Phase I trial of Pharmexa's epitope based recombinant protein vaccine EP1043, which was tested alone and in combination with Pharmexa's epitope based DNA vaccine EP1090.
The HVTN 064 trial enrolled 84 healthy volunteers. The preliminary study analyses indicate the EP1043 protein vaccine is safe and well tolerated when administered alone or in combination with the EP1090 DNA vaccine. Although the data are still blinded, it appears that the protein also induces robust immune responses in the majority of vaccine recipients, with a response rate of approximately 80% in certain dose groups, after only two immunizations. There was no apparent synergistic effect with EP1090.
EP1043 is a recombinant protein composed of 18 conserved Helper T-cell epitopes from the Env, Gag, Pol, and Vpu proteins from HIV. Because the HIV sequences used to identify the epitopes are those commonly observed in infected individuals from all regions of the world, this vaccine is intended to provide worldwide coverage. EP-1043 was designed for use in combination with DNA or viral vectored vaccines for HIV. For the HVTN 064 trial the protein was formulated with Alhydrogel adjuvant.
Mark Newman, Ph.D., SVP, R&D Laboratories at Pharmexa says: "We consider these preliminary results with the EP1043 protein very encouraging. To our knowledge, this vaccine is unique in its design and the demonstration that it is immunogenic and can be administered safely is a significant step forward."
Hørsholm, November 9, 2007
Jakob Schmidt
Chief Executive Officer
Additional information:
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
Claude Mikkelsen, Vice President, Corporate Affairs and Communication, telephone +45 4516 2525 or +45 4060 2558
Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of cancer, serious chronic and infectious diseases. Pharmexa's proprietary technology platforms are broadly applicable, allowing the company to address critical targets in cancer and chronic diseases, as well as serious infectious diseases such as HIV, influenza, hepatitis and malaria. Its leading programs are GV1001, a peptide vaccine that has entered phase III trials in pancreatic cancer and phase II trials in liver cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma and Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs approximately 105 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.
Posted: November 2007
