Preliminary results of a Phase II study indicates that Axelar’s AXL1717 is efficacious in 2nd line treatment of patients with lung cancer


STOCKHOLM, April 2, 2013. Axelar AB, part of the Karolinska Development AB
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.”

*Pivotal trials as presented on FDA approved drug labels for docetaxel,
pemetrexed and erlotinib

For further information, please contact:
Carl Harald Janson, CEO, Axelar AB
Phone: +46 (0) 70 226 91 52, e-mail: carlharald.janson@axelar.se

Torbjörn Bjerke, CEO, Karolinska Development AB
Phone: +46 (0)72 744 41 23, e-mail: torbjorn.bjerke@karolinskadevelopment.com

Terje Kalland, CSO, Karolinska Development AB
Phone: +46 (0)76 891 73 01, e-mail: terje.kalland@karolinskadevelopment.com

TO THE EDITORS

About Axelar

Axelar AB is a Swedish biotech company founded in 2003. The company is
developing insulin-like growth factor-1 (IGF-1) receptor inhibitors for the
treatment of cancer and other diseases. Axelar is part of the Karolinska
Development portfolio of companies. www.axelar.se

About AXL1717

Axelar's lead compound AXL1717 provides a novel potential treatment regimen for
a wide range of cancers. AXL1717 is the first targeted oral small-molecule
insulin-like growth factor 1 (IGF-1) receptor pathway inhibitor with no
observable effect on the closely-related insulin receptor. Most tumor cells are
dependent on the IGF-1 receptor signal pathway and the IGF-1 receptor is
therefore regarded as a promising target for cancer therapy. To date, there are
no IGF-1 receptor inhibitor drugs on the market. Axelar is currently conducting
a randomized phase II clinical trial with AXL1717 in non-small cell lung cancer
patients. A first-in-man phase I/II clinical trial with AXL1717 including 49
patients has been completed demonstrating a good tolerability profile of the
compound, in addition to its superior preclinical efficacy against numerous
tumors.

About Karolinska Development AB
Karolinska Development aims to create value for patients, researchers, and
investors by developing innovations from world class science into products that
can be sold or out-licensed with high returns. The business model is to: SELECT
the most commercially attractive medical innovations; DEVELOP innovations to the
stage where the greatest return on investment can be achieved; and COMMERCIALIZE
the innovations through the sale of companies or out-licensing of products. An
exclusive deal flow agreement with Karolinska Institutet Innovations AB, along
with other cooperation agreements with leading universities, delivers a
continuous flow of innovations. Today, the portfolio consists of 34 projects, of
which 15 are in clinical development. For more information, please visit
www.karolinskadevelopment.com.

Karolinska Development is listed on NASDAQ OMX. Karolinska Development may be
required to disclose the information provided herein pursuant to the Securities
Markets Act.

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