Pharmexa discontinues Phase II trial of breast cancer vaccine
Resumé: Following a review of the preliminary data from the Phase II trial of Pharmexa’s breast cancer vaccine PX 104.1 the company has decided to stop recruitment of new patients.
Based on preliminary results Pharmexa has decided to stop further recruitment of patients to the HER-2 Protein AutoVac(TM) (PX 104.1) Phase II trial, in which the breast cancer vaccine is tested together with the adjuvant QS-21. For this decision, Pharmexa has made use of the data monitoring committee that was established in connection with the trial, as well as external experts. A total of 14 patients with stage IV metastatic breast cancer have been treated with the vaccine.
The preliminary data shows that the HER-2 Protein AutoVac(TM) vaccine was not able to slow down the cancer in the first 10 included patients. The patients progressed during the study period and they were therefore taken off the study according to the protocol and offered other treatments. The remaining patients will be treated according to the protocol before the trial is put on final hold. Based on the preliminary results it is unlikely that the trial would meet its primary endpoint, objective tumor response, if it was finalized. Therefore the trial is stopped now.
Blood samples from the first eight weeks of treatment from five patients that received all four scheduled initial immunizations with HER-2 Protein AutoVac(TM) have been analyzed for antibodies. Four out of these five patients developed the desired antibodies to the HER-2 receptor. The antibody levels are the highest yet seen in patients after an AutoVac(TM) vaccine and are at levels expected to be therapeutically relevant. No serious adverse events related to the vaccine have been reported in the trial. The trial had therefore at this time met its most important secondary endpoints, immune response and safety.
Jakob Schmidt, CEO in Pharmexa says: “We are disappointed about these results. It looks like the patients simply progress before the vaccine has a chance to work. Although the antibody data are interesting and the number of patients treated is small, the conclusion is clear: There is no basis for continuing this trial in very ill metastatic breast cancer patients. Either the patients must be healthier or the vaccine must work faster.”
Significance for Pharmexa’s product portfolio
The trial has confirmed that the AutoVac(TM) technology does give rise to an immune response in advanced cancer patients, and together with the previous Phase I and Phase II trials where the vaccine was tested with the weaker adjuvant alhydrogel, the trial shows that this immune response can be increased with a stronger adjuvant (in this case QS-21).
In the coming weeks the antibody data from the trial will be analyzed further, together with data from the remaining patients. Pharmexa will investigate whether there is any route forward for the product in a different patient population, taking into consideration that further development of PX 104.1 can only be justified by a realistic expectation of a superior product profile over existing products, such as Herceptin® and other new anti-HER-2 agents.
As opposed to advanced breast cancer, Pharmexa’s programs in Alzheimer’s disease and bone disorders are not dependent on the patients mounting an immune response very quickly. Pharmexa will in the coming weeks evaluate particularly its internal cancer programs based on the AutoVac(TM) technology in relation to the new knowledge generated by the trial and in relation to Pharmexa’s semi-annual portfolio evaluation, which takes place in September. Among other things, this portfolio evaluation will take as a starting point that Pharmexa, following the acquisitions of GemVax and Pharmexa-Epimmune, has a number of opportunities for initiating additional clinical trials in cancer and infectious diseases, which are expected to yield attractive returns to Pharmexa’s shareholders in the short to medium term. Pharmexa’s pipeline is broad and with GV1001, which recently entered into Phase III trials, the company is potentially closer to a marketed product today than ever before.
Pharmexa has outlicensed an AutoVac(TM) program aimed at Alzheimer’s disease to H. Lundbeck (PX 106), as well as a DNA version of the HER-2 AutoVac(TM) vaccine (PX 103.2) to Bavarian Nordic, both of which will continue to be supported according to the agreements.
Significance for Pharmexa’s financial situation
The termination of the Phase II trial means that Pharmexa’s clinical costs are reduced for the coming years. For the financial year 2006, the termination will lead to a cost saving of approximately DKK 4 million, while the expected savings in 2007 and 2008 will total approximately DKK 2 million compared to budget.
Hørsholm, August 14, 2006
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.
Briefly about the HER-2 Protein AutoVac(TM) trial
Patients with advanced metastatic breast cancer received four immunizations in the first six weeks of 1,25 mg HER-2 Protein AutoVac(TM) formulated with alhydrogel adjuvant and mixed with QS-21 adjuvant. Hereafter the patients received booster immunizations every fourth week for up to 26 weeks, or until they progressed. The trial was conducted at a number of cancer clinics in Poland, Romania and Russia. The trial would have recruited up to 40 patients with active HER-2 positive breast cancer. The primary endpoint in the trial was tumor regression (measured by RECIST criteria) while secondary endpoints included immune responses and safety.
- Contact Information
- Jakob Schmidt
- Chief Executive Officer
- Pharmexa A/S
- Contact via E-mail
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