HALO Brightens, CPXX Eyes Long Haul, LJPC Awaits Next Catalyst

(RTTNews) - Halozyme Therapeutics Inc. (HALO) rose more than 13 percent to $9.18 in after-hours trading on Wednesday as news of FDA lifting the clinical hold on the company's phase II study of PEGPH20 in pancreatic cancer was greeted warmly by investors.

The clinical hold was imposed by FDA in April of this year following the company's decision to temporarily halt patient enrollment and dosing of PEGPH20 in the study, based on the recommendation of an independent Data Monitoring Committee, to assess the risk of thromboembolic events (blood clots) associated with the compound.

Last month, the independent Data Monitoring Committee recommended that enrollment and dosing in the study resume under a revised protocol.

Accordingly, the FDA has lifted the hold on the study and the company will resume the phase II study of PEGPH20 in pancreatic cancer.

La Jolla Pharmaceutical Co. (LJPC) has completed enrollment in its phase II extension study of GCS-100 in chronic kidney disease, reaching the target of 93 patients.

This study was initiated to study the long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week phase II study. Initial data from the extension study is expected late this year.

LJPC closed Wednesday's trading at $7.82, up 2.96%.

Celator Pharmaceuticals Inc. (CPXX) has achieved 75% enrollment in its ongoing phase III clinical study comparing CPX-351 Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML). The study is designed to enroll 300 patients.

According to the company, the pre-planned safety analysis of the first 150 patients by the Data and Safety Monitoring Board will take place this month, and enrollment is expected to be completed in the fourth quarter of this year.

If things pan out the way as planned, the company may report initial data on the secondary endpoint of remission rate in the second quarter of 2015. The primary endpoint, overall survival, is projected to be available in the first quarter 2016.

CPXX closed Wednesday's trading at $2.47, down 3.14%.