Halozyme Study Clinical Hold Lifted by FDA - Analyst Blog

Halozyme Therapeutics, Inc. HALO announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold from a phase II study (Study 202) evaluating PEGPH20 as a first-line therapy in patients suffering from stage IV metastatic pancreatic cancer.

We remind inventors that in Apr 2014, the FDA had placed a clinical hold on Study 202 following Halozyme's temporary halt on patient enrollment and dosing of PEGPH20. Halozyme's action was based on a recommendation by an independent Data Monitoring Committee (DMC), which indicated a possible difference in the rate of thromboembolism (movement of blood clot from the original source to another blood vessel blocking blood flow in the process) between the patient groups treated with the Abraxane/Gemzar combination, with or without PEGPH20.

Halozyme will resume patient enrollment and dosing of PEGPH20 once the Independent Review Boards at different study sites review and approve the amended protocol for the study. Under the amended protocol, Halozyme will exclude those patients who could be at higher risk of thromboembolic events.

Moreover, low-molecular weight heparin will be administered to patients as a prophylaxis to prevent thromboembolic events. A second primary endpoint has been added under which the rate of thromboembolic events in the patient group treated with PEGPH20 following the amended protocol will be assessed.

Halozyme intends to enroll more than 100 patients in the study in addition to the patients already enrolled.

Our Take

The lifting of the clinical hold on Study 202 by the FDA is a major positive for Halozyme and we expect investors to react positively to this news. We expect investor focus to remain on further updates on the status of this program.

Halozyme carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD, and ANI Pharmaceuticals, Inc. ANIP and Alexion Pharmaceuticals, Inc. ALXN. While Gilead and ANI Pharmaceuticals carry a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).

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