Peregrine reports $17.07 million net loss for 2006

By Jennifer Lanning Drey

Eugene, Ore., July 14 - Peregrine Pharmaceuticals, Inc. reported a net loss of $17.07 million, or $0.10 per basic and diluted share, on revenue of $3.19 million for the year ended April 30, according to a company news release.

The company reported a net loss of $15.45 million, or $0.11 per basic and diluted share, on revenue of $6.0 million for fiscal 2005, according to the release.

The company's cash and cash equivalents on April 30 were $17.20 million.

Since the start of the new fiscal year on May 1, Peregrine has raised an additional $13 million in net proceeds from the sale of shares of stock and had a cash position of $26.30 million as of June 30, according to the release.

Peregrine said its expenses increased in fiscal 2006 due to an increase in research and development, primarily related to bavituximab (formerly Tarvacin).

During that time, Peregrine began two clinical trials of bavituximab, one in cancer therapy and the other for the treatment of chronic hepatitis C viral infections.

"These indications each represent major markets and illustrate the broad potential of this technology platform," said Steven W. King, president and chief executive officer of Peregrine, during a company conference call on Friday.

The company completed a phase 1a clinical trial of bavituximab for the treatment of hepatitis C and reported positive results in February.

1a bavituximab data seen in fall

Based on the safety profile demonstrated in the study, Peregrine later added an additional six patients at a higher dose level to the study, King said.

Those patients are currently in a 12-week follow up period, and the company expects to report final data from the study in the fall at one of the scientific conferences focused on hepatitis C, King said.

In addition, Peregrine began a phase 1b clinical trial of bavituximab for patients with hepatitis C in June that will evaluate four doses of the drug given over a two-week period, King said. The company expects to treat up to four cohorts of six patients each by the end of 2006, he said.

Peregrine's cancer therapy program is also currently enrolling patients with all solid tumor types in a multi-center phase 1 clinical trial for bavituximab.

The primary goal of the trial is to evaluate the safety, tolerability and pharmacokinetics of bavituximab in patients with solid cancer tumors. Patients will also be monitored for disease progression and will be eligible for continued treatment under an extension protocol if they show signs of regression, King said.

"We believe that bavituximab has the potential to be a major cancer drug notwithstanding the other new and investigational drugs now in development," King said.

"It's mechanism of action is truly unique and appears to involve multiple mechanisms including destruction of the tumor blood vessel essential for tumor growth and spread, in addition to blocking cancer's ability to down-regulate the body's normal immune response, allowing a robust immune response to the tumor," he said.

Peregrine hopes to complete enrollment in the phase 1 clinical trial by the end of the year, he said.

"Accelerating enrollment trends at some of our centers are encouraging and increase our confidence that this is an achievable goal," King said.

Cotara trials 'on track'

Peregrine also said Friday that its program for Cotara, its lead tumor necrosis therapy, is back on track.

During the year, the company started a dose confirmation and dosimetry clinical trial for Cotara that previously wasn't moving as quickly as Peregrine had hoped, King said.

"In recent months, we have been working directly with each of the active clinical sites to address the issues that were slowing progress, and we believe that the program is now on track," he said.

The trial is being conducted through a collaboration with the New Approaches to Brain Tumor Therapy Consortium (NABTT).

"We believe Cotara holds tremendous promise for the treatment of deadly disease based on clinical data generated to date, and we look forward to expanding beyond the NABTT study this year to enable us to fully assess the potential of this drug," King said.

The company is also preparing to begin a 40-patient trial that would deliver a single dose of Cotara using an optimized delivery method.

"This trial would allow more comprehensive evaluation of median survival time and safety, allowing us to appropriately design a larger product registration trial," King said.

Peregrine expects to provide more information related to the trial in upcoming months, he said.

Peregrine is a Tustin, Calif., biopharmaceutical company specializing in products for the treatment of cancer and hepatitis C virus infection.

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