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Pharmexa Starts Phase II Trial in Breast Cancer

Posted on: Thursday, 11 November 2004, 09:00 CST

HOERSHOLM, Denmark, Nov. 11 /PRNewswire-FirstCall/ -- Pharmexa will now initiate the first Phase II trial with the HER-2 Protein AutoVac(TM) breast cancer vaccine. The trial that includes up to 50 breast cancer patients will start in Hungary and is expected to conclude by mid 2006. An additional Phase II trial is under preparation.

Pharmexa has obtained the required regulatory approvals for the Phase II trial with the HER-2 Protein AutoVac(TM) breast cancer vaccine and the Hungarian doctors are now ready to recruit patients. We expect that the doctors in Poland will follow within the next few weeks. Depending on the speed with which patients are recruited to the trial, we expect the trial to be concluded by mid 2006.

The HER-2 Protein AutoVac(TM) vaccine has been designed to generate an antibody response against the HER-2 protein, which is over-expressed in many cancer forms including some breast cancers. Pharmexa has previously reported promising Phase I data showing that the vaccine is safe and capable of generating an antibody response. This Phase I trial was not intended to show tumor response. As a next step in the development of the vaccine, the current Phase II trial will investigate the clinical benefit of the vaccine. In addition further investigations of the vaccine's ability to generate the desired antibody responses will be made.

The patients will receive four initial immunizations over a six week period with 1.25 milligram HER-2 Protein AutoVac(TM) formulated in Alhydrogel(TM) adjuvant followed by booster immunizations every four weeks for up to 26 weeks. The trial will be carried out at 5-10 cancer centers in Poland and Hungary. According to the plan the centers will recruit up to 50 patients with active HER-2 positive breast cancer.

We are currently preparing an application for another Phase II trial with the vaccine formulated in a stronger adjuvant (an immunostimulatory substance contained in all vaccines). As is the case with the abovementioned trial, this trial is planned to take place in Poland and Hungary and to include up to 50 patients. We expect that this Phase II trial could be concluded around year- end 2006.

The plans for these two trials are already included in our budgets and guidance regarding the financial year 2004 and onwards. The purpose of running two parallel Phase II trials is to generate as much information as possible about the relationship between vaccine dose, adjuvant and immune response. This way we increase the probability of demonstrating tumor effect in Phase II and increase the value of the program to future license partners.

As previously announced the initiation of the first Phase II trial triggers the option granted by Pharmexa to GlaxoSmithKline to negotiate a license agreement for the HER-2 Protein AutoVac(TM) vaccine. Within 90 days from "first patient, first dose" in Phase II GlaxoSmithKline must inform Pharmexa whether they wish to initiate license negotiations. However, Pharmexa is under no obligation to out-license the vaccine.

Pharmexa's CEO Jakob Schmidt says: "It is always an important milestone when we get a green light from the authorities to initiate a new clinical trial and particularly in this case where we are dealing with a new treatment modality. The approval process in Poland and Hungary has been relatively fast, witnessing the high quality and documentation in our application."

Jakob Schmidt

Chief Executive Officer

Additional information:

Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525

Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa's proprietary AutoVac(TM) 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

Pharmexa A/S

CONTACT: Jakob Schmidt, Chief Executive Officer of Pharmexa A/S, +011-45-4516-2525

Source: PRNewswire-FirstCall

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