Halozyme Therapeutics, Inc. (NASDAQ:HALO) has revealed that enrollment for the Phase 1b/2 trial conducted for the drug PEGPH20 has been temporarily put on hold by SWOG – a researchers’ independent network that deals in designing and conducting clinical trials of cancer therapies. The Phase 1b/2 trial was evaluating the efficacy of PEGPH20 in conjunction with FOLFIRINOX chemotherapy and comparing it to the efficacy of FOLFIRINOX alone. This was for patients suffering from metastatic pancreas cancer that was untreated.
Statistically insignificant
In an early futility analysis that had been planned, it was discovered by SWOG that preliminary data pointed to the fact that a dosage of PEGPH20 taken every fortnight combined with modified FOLFIRINOX did not stand a chance of demonstrating any improvement that was statistically significant compared to a situation where FOLFIRINOX was taken alone. The primary endpoint of the study was overall survival.
Currently, Halozyme Therapeutics and SWOG are collaborating in verifying and analyzing the data set.
“We see every clinical trial involving PEGPH20 as a possibility to advance the study,” the president and chief executive officer of Halozyme Therapeutics, Dr. Helen Torley, said before pledging her firm’s commitment to continue working with SWOG with a view to getting a better understanding of the data and patients who were likely to benefit from PEGPH20.
Investigational drug
With its collaboration partners, Halozyme Therapeutics is conducting ongoing studies for the evaluation of PEGPH20 together with immunotherapies and chemotherapies in breast, lung, gastric, lung and pancreatic cancers. Plans are also underway to start other combination studies in bile duct, gall bladder, gastric, and pancreatic cancers later in the year.
PEGPH20 is an investigational drug that also serves as the lead proprietary program for Halozyme Therapeutics. The biotechnology firm applies a unique way of targeting solid tumors and in animal models this allows the co-administered cancer drug treatments increased access to the tumor. The investigational drug is at present in development for a number of cancers including metastatic breast cancer, gastric cancer, lung cancer and metastatic pancreatic cancer.
On Thursday shares of Halozyme Therapeutics Inc tumbled by 8.82% to close the day at $13.03.