Date: 2011-07-07
Type of information:
phase: 1-2
Announcement: completion of the study
Company: Axelar (Sweden)
Product: AXL1717
Action
mechanism: 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.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Sweden
Trial details: 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.
Latest
news: * On June 2, 2012, Axelar AB, a Karolinska Development AB portfolio company, has announced the release of a poster at The American Society of Clinical Oncology (ASCO) Annual Meeting with data from the Phase I/II trial of AXL1717 that was completed in 2011. The poster is entitled “A novel targeted oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor and its implications for patients with non-small cell lung cancer (NSCLC): A Phase I clinical trial.”
* On July 7, 2011, Axelar AB has 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. A Phase II program in patients suffering from non-small cell lung carcinoma is expected to be initiated in late 2011.
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.
* On April 6, 2011, Axelar AB has announced positive results from the completed first part of the combined Phase I/II clinical trial, evaluating AXL1717 as a new treatment for solid tumors. The study has successfully reached its primary endpoint, identifying the recommended Phase II dose as well as provided evidence that AXL1717 is safe and tolerable. Furthermore, data also supports Axelar’s strategy to target AXL1717 in patients with squamous non-small cell lung cancer. Results will be presented later this year.
In the ongoing study, AXL1717 has been tested in total of more than 45 patients. The now completed first part of the study with a total of 35 patients, consisted of a single-day dosing as well as a multi dosing part. The study has been amended to a Phase II design. AXL1717 is now tested for 28 days BID (twice daily dosing) in two cycles with 14 days interval in order to confirm the Phase II regimens and explore the possible anti-tumor effects. A Phase II program is expected to start late 2011.
