Summary: Pharmexa has been notified by KAEL-GemVax of South Korea that the
independent Data Monitoring Committee (DMC) for the Telovac Phase III trial in
pancreatic cancer has met and recommended continuation of the trial without
modification.
KAEL-GemVax has notified Pharmexa that the DMC for the Telovac Phase III trial
in pancreatic cancer being conducted in the UK has performed a first analysis
of key data collected after more than 220 patients have been enrolled in the
trial.
The DMC is responsible for evaluating the ongoing trial for safety and efficacy
and they concluded that there were no issues and recommended that the trial
continue without any modification. Furthermore, Pharmexa has also been informed
that the Liverpool Cancer Trials Unit (LCTU), which has overall management of
the TeloVac trial, recently received a very positive audit report from the UK
regulator agency (MHRA) for their conduct of the trial. The TeloVac trial is
sponsored by the Royal Liverpool & Broadgreen University NHS Trust.
Pharmexa entered into the deal with KAEL in October, 2008. The terms of the
deal included payments totalling USD 8,000,000 for marketing authorization and
commercialization milestones and royalties of 10% on future sales. According to
Achim Kaufhold, Pharmexa's CEO “the positive DMC and audit results are very
encouraging and demonstrate that the Telovac trial is being conducted in a
highly professional manner. We look forward to the continuation of the trial
and to the further development and ultimate commercialization of GV1001 by
KAEL-GemVax.”
Hørsholm, December 19, 2008
Achim Kaufhold
Chief Executive Officer
Additional information:
Claude Mikkelson, Senior Vice President, Finance and Investor Relations, tel
+45 4516 2525 or +45 4060 2558
Achim Kaufhold, Chief Executive Officer, tel +45 4516 2525
For the editors: Pharmexa A/S is a development stage company in the field of
active immunotherapy. Pharmexa's proprietary technology platforms are broadly
applicable, allowing the company to address critical targets in cancer and
chronic diseases, as well as serious infectious diseases such as HIV,
influenza, hepatitis and malaria. Collaborative agreements include H. Lundbeck
and Bavarian Nordic. Pharmexa is listed on the Copenhagen Stock Exchange under
the trading symbol PHARMX.
