One of the most interesting candidates at Ariad Pharmaceuticals Inc. (ARIA) is AP26113. AP26113 is being evaluated for the treatment of patients suffering from anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC), who are resistant to Pfizer Inc.’s (PFE) Xalkori (crizotinib).
Late last week, ARIAD received encouraging news on AP26113 when the FDA granted Breakthrough Therapy designation to the candidate. Breakthrough Therapy designation is a status provided under the 2012 FDA Safety and Innovation Act. The designation helps to expedite the development and review process of experimental drugs that target serious and life-threatening diseases.
The Breakthrough Therapy designation for AP26113 was granted on the basis of encouraging results from an ongoing phase I/II study. Results from the study demonstrated sustained anti-tumor activity of AP26113 in ALK+ NSCLC patients including those suffering from active brain metastases. The data was presented at the European Cancer Congress.
We are encouraged by AP26113 gaining the Breakthrough Therapy status. According to the American Cancer Society, approximately 85% of the estimated 228,190 new lung cancer cases are diagnosed with NSCLC each year in the U.S. Currently approved NSCLC treatments include Xalkori and Roche’s (RHHBY) Tarceva.
Meanwhile, ARIAD intends to expedite patient enrollment in the ongoing ALTA (ALK in Lung Cancer Trial of AP26113) study and complete the same in the third quarter of 2015. Moreover, ARIAD plans to initiate a front-line study on AP26113 in treatment-naive patients.
ARIAD carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Hyperion Therapeutics, Inc. (HPTX) carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment