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
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.
