HORSHOLM, Denmark, Jan. 19, 2004 (PRIMEZONE) -- Pharmexa has completed the first clinical trial with HER-2 Protein AutoVac(TM) in 10 breast cancer patients in the US. The data show that the vaccine is safe and that it induces HER-2 specific antibodies. Based on these results, Pharmexa plans the continued development of the vaccine through additional clinical investigations in the second half of 2004. Release no. 2/2004
Positive data from the HER-2 Protein AutoVac(TM) trial in the USA Pharmexa has now analysed the results from the patients in the clinical phase I trial with the HER-2 Protein AutoVac(TM) vaccine conducted in the US. Six of the ten patients developed clear antibody responses to HER-2 after immunisation. As expected, these responses declined after the treatments were stopped. No vaccine related serious adverse events were reported.
Soeren Mouritsen, Chief Executive Officer says: "These are very exciting times for Pharmexa. The final results confirm the preliminary analysis and show that the AutoVac(TM) technology works in humans and that we can raise antibodies against an important therapeutic target in breast cancer patients. The results also show that the treatment is safe. It is especially impressive that we obtained these results using a standard aluminium adjuvant in our vaccine formulation. Aluminium adjuvants have the distinct advantage of being free to use, but they are considered to be relatively weak. The ability of the AutoVac(TM) technology to enhance immune responses on its own illustrates the potential of the technology and gives us tremendous flexibility as we move forward with all our projects."
Pharmexa is currently planning a phase II trial, which is expected to commence in the second half of 2004. Depending on the speed of patient enrolment, preliminary results from this study are expected by mid 2006.
The phase I final data will be presented at the 4th European Breast Cancer Conference in Hamburg March 16-20, 2004.
About the HER-2 Protein AutoVac(TM) trial In April 2003 Pharmexa received approval from the FDA to conduct a clinical Phase I trial with the company's HER-2 Protein AutoVac(TM) vaccine at two US breast cancer centres in Cleveland and Pittsburgh.
Pharmexa's clinical Phase I trial included 10 patients with breast cancer. The primary objective of the trial was to evaluate the safety of the HER-2 Protein AutoVac(TM) vaccine and in addition, to evaluate the ability of the vaccine to generate an immune response specifically directed against cancer cells over-expressing the oncogenic protein, HER-2.
Each patient in the trial received a total of four injections (immunizations) with the HER-2 Protein AutoVac(TM) vaccine over a course of 10 weeks. During these 10 weeks and a subsequent 6-week period the patients were monitored for potential adverse reactions. The Investigator (the physician at the breast cancer centres responsible for the conduct of the trial) regularly examined the patients. In addition, blood samples were taken from each patient every second week for all 16 weeks to determine the patient's development of a HER-2 specific immune response (i.e. the desired effect).
The above-mentioned Phase I data are based on clinical observations and antibody results from all 10 patients in the trial.
Other HER-2 AutoVac(TM) products for breast cancer Pharmexa is also developing the HER-2 DNA AutoVac(TM) vaccine for the treatment of breast cancer. In December 2002, Pharmexa announced the successful completion of a phase I/II clinical trial involving 27 patients. Pharmexa did receive approvals for a phase II clinical trial in Denmark and the United Kingdom. However, the HER-2 DNA AutoVac(TM) phase II trial is currently on hold, as the company is evaluating outlicensing and other partner structures for the continued development of this product. Furthermore, in October 2003 Pharmexa and Bavarian Nordic entered into a collaborative agreement that will evaluate the use of Bavarian Nordic's proprietary MVA-BN vector technology in combination with Pharmexa's HER-2 DNA AutoVac(TM) vaccine. The parties expect that a phase l/ll clinical trial could begin in Germany and Italy within 18 months.
Pharmexa believes it will be advantageous to pursue clinical development of these HER-2 products contemporarily since they are designed to induce different, but potentially complementary anti-tumour effects in man. HER-2 AutoVac(TM) products may have important competitive advantages over Herceptin(R) in terms of efficacy, patient convenience and manufacturing costs. Herceptin(R) is Roche and Genentech's monoclonal antibody breast cancer therapy launched in the US in 1998 with global sales of DKK 4.8 billion in 2002.
About Pharmexa A/S
Pharmexa A/S (CSE: PHARMX) is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa's proprietary AutoVaca technology platform is broadly applicable, but the company has focused its resources on a number of cancer forms and chronic inflammatory diseases, with research and development programs targeted towards breast cancer, rheumatoid arthritis and bone degeneration. Collaborative agreements include Schering-Plough, H. Lundbeck and Bavarian Nordic.
For more information please visit www.pharmexa.com