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Pharmexa receives approval to start Phase Ib trial in the US with HIV vaccine


Summary: Pharmexa has received approval from US authorities to start a Phase Ib trial with the HIV vaccine EP1090.The first patients will be treated in the next few weeks.

Relevant US authorities have approved Pharmexa’s application to start a Phase Ib trial of the vaccine EP1090 in HIV-infected patients. In this trial sponsored by Pharmexa, EP1090 is tested using a needle-free injection device chosen to maximize delivery of the vaccine, thus enhancing the vaccine’s ability to stimulate the immune system. The first patients will be treated in the next few weeks.

The trial is a randomized, double blinded, placebo-controlled study in 32 HIV-infected patients receiving antiretroviral therapy (ART). Conducted at one US center with the AIDS Research Alliance (ARA) the trial tests two equal-sized groups dosed with 1 mg or 4 mg of EP1090 administered with the Biojector® 2000. The 24-week trial will consist of weekly vaccine doses for the first five weeks with a 20-week follow-up after the last vaccination. The primary endpoints of the trial are vaccine safety and immunogenicity. Results are expected in the third quarter of 2007.

How does EP1090 work?
EP1090 has been designed to restore and amplify anti-viral immune responses in patients who have been receiving ART. The ultimate treatment goal is to provide a second treatment option to patients that discontinue or fail on standard ART using EP1090 to stimulate their natural immune suppression of HIV replication.

EP1090 is an epitope based DNA vaccine that activates so called cytotoxic T-lymphocytes (CTL or “killer T cells”) of the immune system to attack HIV-infected cells. The vaccine is designed to induce CTL responses but not helper T-lymphocytes (HTL), which are readily infected by HIV. As such, this vaccine is unique because it is specifically designed for therapy. EP1090 encodes 21 CTL epitopes from multiple virus proteins found in all HIV subtypes carefully selected using Pharmexa-Epimmune’s patented EIS(TM) technology. The epitopes selected are believed to be crucial to the fitness of all HIV viral strains, with the result that the virus should be unable to mutate away from immune responses targeted by EP1090. Such mutation has presented an obstacle to conventional whole antigen HIV vaccine development.

EP1090 has previously been successfully tested both in HIV-infected patients and in healthy volunteers. In addition, EP1090 is currently being tested in combination with the vaccine EP1043 in a large Phase I trial sponsored by the United States’ National Institutes of Health (NIH), Division of AIDS (DAIDS) through the HIV Vaccine Trials Network. This trial includes 120 healthy volunteers in the United States and Peru. Results are expected towards the end of 2007.

Pharmexa’s programmes in HIV
Through its US subsidiary Pharmexa-Epimmune, Pharmexa works with both therapeutic and prophylactic vaccines against HIV. The company has a broad portfolio of vaccine candidates in HIV, which are developed in-house, in collaboration with the health authorities in the United States or in collaboration with other companies. A number of Pharmexa-Epimmune’s programmes in HIV are financed in whole or in part by the NIH.

The central hypotheses in Pharmexa’s work on therapeutic HIV vaccines is that the company’s vaccines can stimulate a CTL-based immune response that helps the patient control the virus after infection has taken place. Pharmexa’s most advanced project here is the vaccine EP1090.

The central hypotheses in Pharmexa’s work on prophylactic HIV vaccines is that the company’s vaccines can stimulate both a CTL and a HTL based memory immune response that would be re-activated upon HIV infection. The most advanced vaccines in the prophylactic pipeline are the EP1090 + EP1043 combination product, and the EP1233 DNA vaccine which is designed for use with the viral vector vaccine MVA-BN32, which has been developed in collaboration with the Danish biotech company Bavarian Nordic.

Briefly on HIV
HIV and the ensuing disease AIDS has caused more than 25 million deaths since the disease was first observed in 1981. HIV infection threatens a large percentage of the population in many developing countries. In 2005 there were almost 5 million new cases of HIV infection, which brought the total number of HIV infected individuals above 40 million world-wide, and more than 3 million AIDS related deaths that year. The HIV epidemic has therefore not by any standard been contained.

Antiretroviral drugs have seen a large increase in sales since 2000 and these drugs are now used for treating the HIV infected not just in the western world but also in many low- and middle income countries. In 2004 alone the global market for HIV antiretrovirals exceeded USD 6 billion, with the United States comprising approximately 70% of the market. The antiretrovirals have reduced the mortality for the treated patients and made HIV infection a chronic but manageable disease for some of the patients. However, there is still a great need for preventive vaccines, particularly in the non-western world and for vaccines that can help those patients that do not respond optimally to the standard antiretroviral drugs.

Hørsholm, August 29, 2006
Jakob Schmidt
Chief Executive Officer

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, rheumatoid arthritis, 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 is expected to enter a phase II trial in liver cancer soon, as well as a number of 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 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.

The AIDS Research Alliance (ARA) is a not-for-profit medical research organization, founded in 1990, whose mission is to find and accelerate the development of promising treatments and vaccines for HIV-1/AIDS.


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