With Peregrine Pharmaceuticals anticipating the release of Phase II data for two oncology candidates - Cotara for glioblastoma multiforme and bavituximab for breast and non-small cell lung cancer - the Tustin, Calif., biotech has set a primary goal of landing a development and marketing partner this year, CEO Steven W. King said during a March 11 conference call.

While detailing third-quarter 2008 financial data (for the quarter ended Jan. 31), Peregrine also announced that Cotara, a monoclonal antibody tumor necrosis compound linked to a radioactive isotope, is showing strong results in a Phase I dosing and dosimetry study and a Phase II safety and efficacy trial.

In a same-day interview with "The Pink Sheet" DAILY, King said that if Cotara continues along its present path, it could move into Phase III late next year.

During the call, King said Peregrine has had discussions with 40 pharmas in the U.S., Europe and Asia to seek a development partner. He told the DAILY his company needs a deep-pocketed partner to fund Phase III development of its top compounds.

"I think with these monoclonal antibody-based therapies, we really need a marketing partner for the technology, particularly if you use Genentech as the gold standard in developing and marketing antibodies," King said. "If you look at their strategy, it was really to run just an enormous number of Phase II and Phase III trials and really to have those resources and the expertise necessary to run those trials."

Bavituximab in particular will need a development and commercialization partner, King said, while Peregrine might be able to commercialize Cotara in-house because a brain cancer drug likely would require a smaller sales force.

Peregrine is open to licensing worldwide or regional rights to its compounds, he said. The recent addition of Mary Boyd as head of business development for Europe and Asia is moving this process forward, King said. She brings contacts from her tenure with GlaxoSmithKline, particularly in the Japanese pharma community.

The company's Beijing, China, subsidiary, opened in January 2007, has been a home office for advancing Peregrine's efforts to find its potential partner in Asia, King added (¹ Also see "Peregrine Establishes China Subsidiary" - Pink Sheet, 12 January, 2007.).

In the Cotara Phase I trial, patients with GBM, the deadliest form of brain cancer, receive an initial imaging dose before a therapeutic dose is administered. Data from the study's initial cohort show the drug is safe and well-tolerated, with no dose-limiting toxicities.

Further, while patients diagnosed with GBM generally are given a six-month survival timeframe, the first patient treated in the Phase I trial has survived 15 months post-treatment, Peregrine notes. Dosimetry analysis also shows the drug is concentrated in the patients' brain tumors, and not in their other organs.

Data from the trial will be detailed at the American Society of Clinical Oncology meeting May 30-June 3 in Chicago.

A Phase II safety and efficacy trial has reached 20 percent enrollment, Peregrine said. This study is testing convection-enhanced delivery of Cotara, which the company maintains should deliver the drug into the tumor with great precision.

Peregrine intends to complete enrollment by mid-2008, in hopes the trial will generate news and data that could attract a partner, King told the DAILY. "That gives us data that will be really nice from a partnering standpoint ... as that data matures," he said.

Endpoints are overall patient survival, progression-free survival and proportion of patients alive at six months. The first dosed patient has reached eight months of post-treatment survival.

Meanwhile, bavituximab is being tested in Phase II as combination therapy with docetaxel in patients with advanced breast cancer, and has just been approved for additional Phase II trials with carboplatin and paclitaxel in advanced breast cancer and NSCLC patients. Both trials will begin enrolling in April, King said. Data from the Phase II studies are expected this year, he added.

Earlier this month, the journal Clinical Cancer Research published a preclinical study showing that bavituximab, when labeled with a radioisotope, preferentially targets tumor blood vessels, localizing to tumors rather than noncancerous organs.

In a Phase Ib trial, bavituximab used in tandem with chemotherapy showed a safety profile consistent with chemotherapy alone, Peregrine reported, while achieving objective response or disease stabilization in 50 percent of the patients who could be evaluated.

In the upcoming Phase II trials, Peregrine will use initial treatment groups of 15 (breast cancer) and 21 (NSCLC) patients to form a "go or no-go" decision whether to proceed to the full trial. King said the breast cancer trial would have 46 patients if completed and the NSCLC trial 49 patients.

"It is worth noting that our positive experience with (the prior Phase II) trial also provides a useful model for other Phase II trials," he said during the investor call. "We took care to invest the necessary time for the extensive planning and onsite coordination needed to run an efficient trial. And we are now reaping the benefits through rapid patient screening and entry into the trial."

Finding a partner could be crucial for continuing the development of Cotara and bavituximab, as Peregrine announced a net loss of $6.2 million for the fiscal third quarter (ended Jan. 31), up year over year from $5 million.

The company's stock price also is troubled, ending the day at $0.52. Peregrine recently received an extension from NASDAQ to stay in compliance for listing by achieving a share price of at least $1. During the call, Chief Financial Officer Paul Lytle said Peregrine prefers to attempt to increase the value of its stock rather than ameliorate the problem with a reverse split, which would not increase shareholder value.

-Joseph Haas (j.haas@elsevier.com)

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