Halozyme Therapeutics, Inc.
) 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.
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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
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
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
ZIOPHARM Oncology, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).