Karolinska Development AB (publ)

July 07, 2011 03:10 ET

Axelar reports completion of the Phase I/II safety study with AXL1717 in cancer patients

STOCKHOLM, SWEDEN--(Marketwire - Jul 7, 2011) - Axelar AB, a Karolinska Development portfolio company, today announced the completion of the Phase I/II clinical safety trial carried out in Sweden in patients with solid tumors. The preliminary results of the study will be presented at the European Multidisciplinary Cancer Congress (ESMO) meeting in Stockholm, Sweden, on September 26, 2011.

Axelar's drug candidate, AXL1717, was administered to a total of 49 advanced- stage cancer patients with progressive solid tumors and no remaining treatment options. The open label safety trial consisted of three parts; a single day BID (twice daily) ascending dose part, a 7-28 days BID dose finding part, and an extension part at a fixed dose for 28 days BID in two cycles 14 days apart. The final report from the study is expected to be completed in the second half of 2011. A Phase II program in patients suffering from non-small cell lung carcinoma is expected to be initiated in late 2011.

The results from the study will be presented at the ESMO congress on Monday, September 26, 2011, 2:00-4:30 pm. The abstract no 9013 is titled "Phase I dose-escalation study of AXL1717: a novel targeted oral Insulin-like Growth Factor-1 receptor (IGF-1R) inhibitor and its implications for patients with non- small cell lung carcinoma", lead author Ekman, S.

Dr. Johan Harmenberg, CEO, Axelar:

"We are very pleased that we continue to make progress with our AXL1717 program and excited to be able to present the results from this first-in-man study at ESMO in September. The study supports Axelar's strategy to target AXL1717 in patients with non-small cell lung cancer. We are now focusing on the upcoming Phase II program and we remain confident that AXL1717 has the potential to be an effective treatment in lung cancer with a novel mechanism of action."

Dr. Torbjörn Bjerke, CEO, Karolinska Development:

"We are encouraged to see that Axelar continues to develop according to plan and look forward to see more data from the now finalized trial. As the largest shareholder, we are excited that Axelar now has completed this important milestone in the development towards a potential new cancer treatment."

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 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 treatment regimen for a wide range of cancers. AXL1717 is the first targeted oral small-molecule IGF-1 receptor inhibitor with no effect on the closely related insulin receptor. AXL1717 is presently undergoing Phase I/II clinical trials and the compound combines a superior preclinical efficacy against numerous tumors with an excellent tolerability profile. 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.

About Karolinska Development

Karolinska Development aims to create value for investors, patients, and researchers by developing innovations from world class research 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 these 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. This will result in upfront payments, milestone payments and royalties.

An exclusive deal flow agreement with Karolinska Institutet Innovations AB, along with other cooperation agreements with leading Nordic universities, delivers a continuous flow of innovations.

Karolinska Development's flexible exit strategy enables projects to be exited at whichever stage of development offers the greatest return on investment, usually after Phase II clinical trials have indicated the desired pharmaceutical effect on patients - this being an important value enhancing step.

Today, the portfolio consists of over 40 projects at various stages, from concept development to Phase II clinical trials, twelve projects are in clinical trials with six in Phase II. The portfolio is particularly strong in the areas of cancer, dermatology, inflammation, cardiovascular disease, women's health and diseases that affect the central nervous system. www.karolinskadevelopment.com

Read Press Release as PDF: http://hugin.info/143071/R/1528917/464483.pdf

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Source: Karolinska Development AB (publ) via Thomson Reuters ONE

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Contact Information

  • For further information, please contact:
    Johan Harmenberg
    CEO
    Axelar AB
    Phone: +46 (0) 705 14 54 53
    e-mail: Email Contact

    Torbjorn Bjerke
    CEO
    Karolinska Development AB
    Phone: +46 (0)72 744 41 23
    e-mail: Email Contact