Phase II study shows effectiveness of Axelar's AXL-003 in treating patients with NSCLC

Axelar AB, part of the Karolinska Development AB (STO:KDEV) portfolio, announced today that preliminary interim results of its Phase II study AXL-003, indicates that AXL1717 is effective in treating patients with non-small cell lung cancer (NSCLC). Thus, the company assesses that it has sufficient data to guide further development of the drug, and will finalize the study with fewer patients than initially planned.

Dr. Carl Harald Janson, CEO, Axelar AB "We are delighted to see the impact of AXL1717 in this difficult to treat patient population. The encouraging trial data provides a platform for the further development of AXL1717. I look forward to finalizing this trial and preparing for the next step in development."

The study is a randomized open-label Phase II clinical study that compares AXL1717 with docetaxel, a well-established anti-cancer treatment, in patients with previously treated, locally advanced or metastatic NSCLC. The clinical study is conducted at 25 centers in five countries and has rate of progression free survival (PFS) after 12 weeks as the primary endpoint. Preliminary analysis suggests that AXL1717 has similar rate of PFS after 12 weeks as docetaxel. The most frequent serious adverse events in the study were cases with neutropenia, which occurred in both treatment regimes.

NSCLC is the most common form of lung cancer with 420,000 new patients diagnosed in the industrial countries every year. The 5-year survival rate for these patients is only 10-15%, resulting in an annual mortality of approximately 330,000 patients. Approximately 90-95% of NSCLC patients do not respond to the most common second line treatments. AXL1717 has the potential to become a new treatment that could extend the lifespan and decrease the suffering for these non-responders. The data add to the positive results obtained with AXL1717 in its Phase I/II study, which was reported in October 2011.

Based on the interim data from AXL-003, Axelar has decided to finalize the trial with approximately 100 patients instead of the planned 140. As of today, 97 patients have been enrolled in the trial and these patients will continue to be treated and monitored according to the study protocol. More detailed data from the study, including secondary read-outs and safety, will be presented at a coming scientific meeting.

Dr. Torbjörn Bjerke, CEO, Karolinska Development AB "This is an important milestone for Axelar and encouraging for lung cancer patients as there is a lack of effective and tolerable treatments for patients who relapse after second line therapy. Based on these interim results, we believe that AXL1717 has the potential to become an important part of future treatment options available to clinicians as well as a valuable asset for Karolinska Development."