Pharmexa files application to start the second clinical Phase II study in breast cancer
Pharmexa has filed an application with the Hungarian regulatory authorities for the second Phase II trial with the company's HER-2 Protein AutoVac(TM) breast cancer vaccine. The trial, which includes up to 50 breast cancer patients, is expected to conclude in the second half of 2006.
The first and ongoing Phase II trial tests the HER-2 Protein AutoVac(TM) vaccine formulated in Alhydrogel adjuvant. The second Phase II trial will test the same vaccine in combination with QS-21, a proprietary adjuvant we recently licensed from Antigenics. QS-21 is generally considered a stronger adjuvant than Alhydrogel. 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. In this way Pharmexa increases the probability of demonstrating tumor effect in Phase II before the end of 2006 and increase the value of the program to future license partners.
In the first Phase II trial, where the vaccine is tested using Alhydrogel adjuvant, Pharmexa will perform an intermediate assessment of the immune response and safety when the first 10 patients have been treated. It will then be evaluated according to predefined criteria whether to continue recruitment of the remaining patients in this trial, or focus on enrolment of the second trial, in which the vaccine is tested together with the QS-21 adjuvant. With this strategy, we have the opportunity, based on predefined criteria, to focus the resources on the Phase II trial with the most promising immune response and safety results. Depending on the outcome following the first 10 patients Pharmexa may choose to pursue both trials to completion.
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 investigate tumor response. As a next step in the development of the vaccine, the current Phase II clinical program 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.
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