07/15/2011 | 06:20 am
Peregrine Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2011 Financial Results and Recent Developments
Three Phase II Programs Advancing in Oncology and HCV Infection Indications
TUSTIN, CA -- (MARKET WIRE) -- 07/14/11 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today announced financial results for the fourth quarter and fiscal year (FY) 2011 ended April 30, 2011 and provided an update on its advancing clinical pipeline and other corporate developments.
"During this fiscal year, we advanced our clinical pipeline significantly by reporting promising clinical data from five trials and launching four new randomized Phase II trials and four investigator-sponsored trials for our lead clinical product bavituximab, building for what we expect to be an exciting fiscal year 2012," said Steven W. King, president and chief executive officer of Peregrine. "Our primary focus for the second half of this year is to continue advancing our three Phase II clinical programs for bavituximab and Cotara® and to reach important and potentially value-building clinical and regulatory milestones. This effort will be led by our management team, which has been expanded with additional clinical, quality, and manufacturing experts with experience in developing and commercializing biological therapies similar to our bavituximab and Cotara programs."
Clinical Program Update
Bavituximab Clinical Trials
In four ongoing randomized Phase II trials, Peregrine is evaluating bavituximab's broad therapeutic potential in non-small cell lung cancer, pancreatic cancer, and hepatitis C virus (HCV) infections. Bavituximab is a first-in-class monoclonal antibody that targets the highly immunosuppressive molecule phosphatidylserine (PS), enabling the immune system to recognize and fight cancer and viral infections.
-- Phase II front-line NSCLC trial evaluating bavituximab with carboplatin
and paclitaxel versus carboplatin and paclitaxel. Enrollment of up to
86 patients is expected to be completed over the next few weeks with
interim data expected by the end of this year. Last month, Peregrine
reported promising 12.4 months median overall survival (OS) from a
prior single-arm Phase II trial using this same therapeutic regimen in
49 front-line NSCLC patients. The OS was consistent with encouraging
earlier data, including 43% objective response rate (ORR) and 6.1
months median progression-free survival (PFS). These data exceed the
10.3 month OS, 15% ORR, and 4.5 months PFS reported from a separate
historic control trial evaluating carboplatin and paclitaxel alone in a
similar patient population.
-- Phase II second-line non-small cell lung cancer (NSCLC) trial
evaluating bavituximab with docetaxel versus docetaxel plus placebo.
Peregrine has modified patient enrollment criteria and has 37 sites
open in the U.S. and internationally and expects to complete enrollment
of up to 120 patients early in the fourth quarter of this year. The
primary endpoint for this study is overall response rate and these data
are expected to be unblinded in the first half of 2012. Secondary
endpoints include median OS and median PFS.
-- Phase II pancreatic cancer trial evaluating bavituximab with
gemcitabine versus gemcitabine is currently enrolling up to 70 patients
with previously untreated stage IV pancreatic cancer.
-- Phase II trial in patients with previously untreated genotype-1
hepatitis C virus (HCV) infection, Peregrine is measuring the early
virologic response (EVR) rate after 12 weeks of therapy with
bavituximab in combination with ribavirin versus standard of care,
pegylated interferon alpha 2a and ribavirin.
To further evaluate bavituximab's broad potential in additional oncology indications and therapeutic combinations, Peregrine's investigator-sponsored trials (IST) program has four currently enrolling clinical trials.
-- Phase I/II trial evaluating bavituximab combined with sorafenib in
approximately 50 patients with advanced liver cancer. This IST is
being conducted at University of Texas Southwestern Medical Center.
-- Phase I/II trial evaluating bavituximab combined with cabazitaxel in 31
patients with second-line castration resistant prostate cancer (CRPC).
This IST is being conducted at the University of California, Irvine.
-- Phase Ib trial evaluating bavituximab combined with pemetrexed and
carboplatin in up to 25 front-line NSCLC patients. This IST is being
conducted at the University of North Carolina at Chapel Hill.
-- Phase I trial evaluating bavituximab combined with paclitaxel in
patients with HER2-negative metastatic breast cancer. This IST is
being conducted at the Arizona Cancer Center at UMC North.
Cotara® Phase II Brain Cancer Program
At the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June, Peregrine reported promising interim OS data of 8.8 months (38 weeks) from a Phase II trial treating 41 patients with recurrent glioblastoma multiforme (GBM) with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered as a single-infusion treatment directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue. Peregrine plans to meet with the FDA in the fourth quarter of 2011 to determine the optimal registration pathway for Cotara.
For more information on Peregrine's clinical trials, please visit http://www.peregrinetrials.com/ .
This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
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