Halozyme Therapeutics, Inc.
) 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.
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.
ANI Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
). While Gilead and ANI Pharmaceuticals carry a Zacks Rank #1
(Strong Buy), Alexion holds a Zacks Rank #2 (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
HALOZYME THERA (HALO): Free Stock Analysis
ANI PHARMACEUT (ANIP): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
To read this article on Zacks.com click here.