Pharmexa starts phase I trial in HIV together with HVTN

Summary: Pharmexa, together with the HIV Vaccine Trials Network, opens a phase I study to test the safety of two HIV vaccines developed by Pharmexa-Epimmune.

Hørsholm, January 27, 2006, Pharmexa-Epimmune Inc., a US subsidiary of Pharmexa A/S, and the HIV Vaccine Trials Network (HVTN) announces today the opening of a phase I study designed to test the safety of two HIV vaccine candidates developed by Pharmexa-Epimmune. This trial will test whether the two study vaccines, which are designed for use in combination, are well tolerated, and whether they cause appropriate immune responses in people. The first study vaccine, EP HIV-1090, is a DNA plasmid that has been tested previously in humans and shown to be safe. The second study vaccine, EP-1043, is a recombinant protein that is being tested for the first time in humans.
“We are pleased to be partnering again with Pharmexa-Epimmune to continue the investigation of EP HIV-1090, and to begin study of EP-1043 in humans,” said Ann Duerr, head of the Scientific Support Group at HVTN. “With the addition of this new protocol with Pharmexa-Epimmune, the HVTN has 15 protocols open, demonstrating the world’s largest commitment to the search for an HIV vaccine.” Marc Hertz, PhD, CEO at Pharmexa-Epimmune says, “We are very pleased to be collaborating and reaching this milestone together with the HVTN. It is an important step in our R&D programs to produce a clinical candidate and to initiate phase I testing.”
About the study vaccines
EP-1043 is an epitope-based recombinant protein vaccine designed to induce HIV-1 specific helper T-lymphocyte (HTL) responses. The vaccine consists of a string of 18 HIV-derived HTL epitopes, each separated by a spacer designed to optimize potency. The EP-HIV-1090 DNA vaccine encodes 21 HIV-1 derived cytotoxic T-lymphocyte (CTL) epitopes, which are highly conserved amongst viral subtypes. The epitopes in both vaccines were selected using Pharmexa-Epimmune’s proprietary Epitope Identification System (EIS™) and each of them is predicted to be recognized in the majority of the prospective patient population.
Study details
The trial will enrol about 120 people in the United States and Peru. It has two parts, Part A (24 people) and Part B (96 people). Part A is evenly divided into two groups (Group 1 and 2) of 12 people each. Over the course of six months, these groups will receive four injections of protein vaccine, Group 1 at a dose of 0.05 mg and Group 2 at a dose of 0.2 mg. The researchers will determine whether the lower dose is safe and well tolerated before escalating to the higher dose. (Participant safety is monitored very carefully; any dose that does not appear safe will be stopped.) For comparison, a few people in each group are given a control, an injection which lacks the active protein or DNA of the study vaccines.

Part B, which begins only after Part A is complete, is divided into three groups, one group of 24 people (Group 3) and two groups of 36 people (Group 4 and 5). Over the course of six months, Group 3 will receive four injections of protein vaccine at the highest dose from Part A that the researchers consider suitable to give to more people. Group 4 will receive four injections of DNA vaccine, and Group 5 will receive four injections of both vaccines. As in Part A, some people will be given a control instead of vaccine.
Because the study is “double blind” neither the participants nor the researchers will know whether an individual has been assigned to the group receiving the study vaccine or the group receiving the placebo.
About HIV
According to UNAIDS, more than 40 million people are now living with HIV. With more than 13,000 new HIV infections each day, 95 percent of which occur in developing countries, the global epidemic shows no sign of abating. UNAIDS has reported that a record 3.1 million people died of AIDS in 2005, the highest number for any year since the epidemic began. As with other infectious diseases, development of a vaccine is recognized as the best long-term hope to end the AIDS pandemic. Vaccines are a critical part of an integrated strategy to fight HIV infection, which also includes treatment and prevention.
The phase I trial is sponsored by the Division of AIDS, National Institutes of Health. Pharmexa-Epimmune’s costs associated with delivery of the vaccines are included in Pharmexa’s budgets and projections for 2006. The rights to the vaccine belong to Pharmexa-Epimmune.

Note to editors:
Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of 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 about to enter phase III trials in pancreatic cancer, HER-2 AutoVac™ Protein, a recombinant protein vaccine in phase II against breast 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 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.
This study, known as HVTN 064, will be conducted at sites in Baltimore, Maryland; Rochester, New York; San Francisco, California; Lima, Peru; and Iquitos, Peru. The HVTN, which is funded and supported by 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 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle, and conducts research in 27 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 (salex@hvtn.org; +1.206.667.5296).

Contact Information

Jakob Schmidt

Chief Executive Officer

Pharmexa A/S

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