Successful Phase I/II Clinical Trial Results from Cancer Patients Treated with Anticancer Drug from Axelar AB.

STOCKHOLM, SWEDEN 2009-05-06

Axelar AB today announced successful completion of the single-day oral dosing part of its ongoing phase I/II clinical trial on cancer patients with its new anti-cancer drug AXL1717,an insulin-like growth factor-1 (IGF-1) receptor inhibitor which has no effects on the closely related insulin receptor. The study is conducted in Sweden on patients having terminal cancer disease. The results showed that a single-day dosing of AXL1717 could be successfully escalated with excellent tolerability. No dose-limiting toxicity was reported. The next part of the trial has now been approved, including a seven-day dosing BID regimen instead of single-day BID treatments. The first patients have already been treated with AXL1717 for seven days.

The ongoing phase I/II clinical trial is primarily designed to assess the safety, tolerability, and pharmacokinetics of the drug. As a secondary objective, anti-cancer effects are documented whenever possible.

"We are very pleased that high doses of AXL1717 could be administered to patients without significant side effects during the single-day treatments.", says Johan Harmenberg, CEO of Axelar AB. "Targeting cancer cells with AXL1717 instead of conventional cytotoxic chemotherapy may be a new and well-tolerated treatment alternative for cancer patients in the future".

The IGF-1 receptor is a promising target for the treatment of cancer, since the receptor is crucial for the survival and growth of malignant cells. In contrast, the IGF-1 receptor is not absolutely necessary for growth of normal cells.

AXL1717 is a small-molecule IGF-1 receptor inhibitor with no effect on the important and almost identical insulin receptor. Pre-clinical data show an extraordinary anti-tumor efficacy in animal models, including apparent complete tumor regression, for a wide range of human cancers such as breast cancer, prostate cancer, malignant melanoma, multiple myeloma, glioblastoma and sarcoma. AXL1717, orally administered, is being developed as a new type of anti-cancer drug.