Halozyme Study Under Clinical Hold - Analyst Blog

Halozyme Therapeutics, Inc. HALO announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on patient enrollment and dosing of PEGPH20 in an ongoing phase II study (Study 202). The study is evaluating PEGPH20 as a first-line therapy for patients suffering from stage IV metastatic pancreatic cancer.

The FDA decided to place the clinical hold following the company's announcement that it is temporarily halting patient enrollment and dosing of PEGPH20. Halozyme took this action on the basis of a recommendation by an independent Data Monitoring Committee (DMC). The DMC 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 a combination of Abraxane (nab-paclitaxel) and Gemzar (gemcitabine), with or without PEGPH20.

Halozyme confirmed that it will furnish additional information related to the rate of thromboembolic events to the FDA and the DMC simultaneously, enabling them to evaluate the data from Study 202.

Our Take

We are concerned about the clinical hold placed on the phase II study. We note that Halozyme had plans to start a study on PEGPH20 for a second solid tumor setting in the fourth quarter of 2014. However, now that the FDA has placed a clinical hold, we have low visibility as to when the hold will be lifted and the program can be continued.

We expect investor focus to remain on further updates on the status of this program.

Halozyme holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alkermes plc ALKS, Amgen Inc. AMGN and ZIOPHARM Oncology, Inc. ZIOP. All these stocks carry a Zacks Rank #1 (Strong Buy).