Summary: Pharmexa-Epimmune, a wholly-owned US subsidiary of Pharmexa A/S, and Bavarian Nordic today announced the initiation of a Phase I trial testing of the two HIV vaccines EP1233 and MVA-BN Polytope in combination.
Pharmexa-Epimmune and Bavarian Nordic today announced the initiation of a Phase I trial testing two HIV vaccines EP1233 and MVA-BN Polytope in combination. The clinical trial will be conducted by the HIV Vaccine Trials Network (HVTN) which is supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The HVTN will enrol up to 108 uninfected volunteers in the US. Interim results are expected by the end of 2007.
Marc Hertz, CEO of Pharmexa-Epimmune said: "This is an important milestone for Pharmexa as we continue our efforts to develop HIV vaccines in collaboration with the NIH. We are still searching for the best method to deliver epitopes in the HIV setting and this approach, DNA prime: MVA boost, is one of the most promising approaches in this field."
The study vaccines were developed by a Pharmexa-led consortium through a contract with NIAID, which to date has provided more than USD 10.0 million to develop a broad HIV vaccine for worldwide use with a population coverage across all ethnic and racial populations.
Pharmexa and Bavarian Nordic share the marketing rights for both vaccines.
Hørsholm, April 30, 2007
Jakob Schmidt Chief Executive Officer
Additional information: Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525 Claude Mikkelsen, Head of Investor Relations, 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, bone degeneration and Alzheimer's disease, 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, ImmunoVaccine Technologies 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.
Bavarian Nordic (CSE: BAVA) is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer. With operations in Denmark, Germany, the USA, and Singapore, Bavarian Nordic employs over 200 people. Bavarian Nordic's patented technology, MVA-BN®, is as been demonstrated in clinical studies, one of the world's safest, multivalent vaccine vectors for the development of vaccines against various infectious diseases such as smallpox, HIV/AIDS, as well as against breast and prostate cancer. Several MVA-BN®-based HIV and smallpox vaccines are in clinical Phase I and Phase II trials. Bavarian Nordic has ongoing development contracts with the US government to develop IMVAMUNE® as a safe third generation smallpox vaccine. Bavarian Nordic has supplied several other governments with smallpox vaccines. Bavarian Nordic's partners include Pharmexa, Impfstoffwerk Dessau-Tornau (IDT) and Vaccine Solutions in Australia. For more information please visit www.bavarian-nordic.com
This study, known as HVTN 067, will be conducted at sites in Nashville, Rochester and San Francisco. The HVTN, which is funded and supported through a cooperative agreement with the National Institute of Allergy and Infectious Disease (NIAID), part of the United States National Institutes of Health (NIH), is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The network comprises more than 24 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle, and conducts research in 26 cities in the United States, Caribbean, South America, Africa and Asia. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company. Working with industry and government, the HVTN seeks to expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. For more information, please visit www.hvtn.org or contact Sarah Alexander ([email protected]; +1.206.667.5296).