Peregrine Pharmaceuticals Inc., with the nod from the FDA, is ready to enroll the first patients in its Phase III trial of Cotara in recurrent glioblastoma multiforme. Now all it needs is a partner.

"We're in discussions with several companies," said Edward Legere, Peregrine president and CEO. "We're looking for a partner right now, so the partner will enroll the first patients."

The Tustin, Calif.-based company had its end-of-Phase II meeting with the FDA in 2001, but Legere said his company and the agency "were working some things out" since then. (See BioWorld Today, Dec. 14, 2001.)

Peregrine's stock (NASDAQ:PPHM) rose on the news, climbing 11 cents Monday, or 16.4 percent, to close at 78 cents.

Cotara is a tumor necrosis therapy monoclonal antibody that carries the radioactive isotope iodine-131. It is designed to bind to dead and dying regions of solid tumors and deliver its therapeutic agent. The Phase III trial would, when initiated, involve more than 400 patients with first recurrence of glioblastoma multiforme. Two patients will receive Cotara for every one that gets temozolomide. The endpoint will be survival, Legere said, and Peregrine will be looking for a 40 percent approval over temozolomide. Secondary endpoints would include side effects and time to progression, he said.

There has not been a statistically significant comparison of temozolomide vs. Cotara, but a Phase II study showed that among the 13 patients who received a total dose between 1.5 and 2.5 mCi/cc of Cotara, the median time to progression and median survival time were 16.9 weeks and 44.3 weeks, respectively. Peregrine said the data suggest Cotara has a chance to improve survival when compared to temozolomide.

Cotara also is being studied in multiple Phase I studies in solid tumors.

Next in the pipeline for Peregrine is Oncolym, a radiolabeled Lym-1 antibody, and the product in a Phase I/II trial at five centers. Like with Cotara, Peregrine is looking to partner the product.

Peregrine's platform includes vascular targeting agents and vasopermeation enhancement agents. It hopes to have a vascular targeting agent in the clinic next year, Legere said, and has a fully human antibody with a permeability-enhancing peptide attached to it being developed in its vasopermeation program.

"We've wrapped up preclinical on that and are looking for a partner," he told BioWorld Today. It also is developing antibodies in the anti-angiogenesis field, he added, and has other preclinical programs as well.

As of Nov. 30, Peregrine had $6.1 million in cash and cash equivalents. Last week it received a 180-day grace period from Nasdaq to regain compliance with the $1 minimum closing bid price, and Peregrine now has until Aug. 15 to maintain a closing price of at least $1 for 10 consecutive trading days. If the SEC approves the proposed pilot program for Nasdaq that allows SmallCap companies up to 540 days to rectify transgressions of the core listing criteria, Peregrine said it would have until possibly August 2004.

For Cotara, what comes next depends on a deal, but in general, Peregrine is a lot like a shopkeeper these days, displaying its wares.

"We're just very active in licensing and partnering right now," Legere said. "We are looking for companies that are looking for products."