National Editor

Maxim Pharmaceuticals Inc. nailed down a potential $27 million licensing deal centered on its apoptosis-inducing cancer compounds with Myriad Genetics Inc.

The deal, with an undisclosed up-front payment, involves preclinical compounds in the MX90745 series, of which the lead compound is MX128495.

"We'll be working closely with [Myriad] through the entire program," said Larry Stambaugh, chairman and CEO of San Diego-based Maxim. "We're going to give this compound the best shot we can. The next steps are to do some of the toxicology work," and prepare for an investigational new drug application filing, he added.

Maxim's stock (NASDAQ:MAXM) closed Tuesday at $8.11, up 55 cents. Myriad's shares (NASDAQ:MYGN) ended the day at $12.76, up 37 cents.

Compounds in the MX90745 series have demonstrated potency in the low nanomolar range in prostate, breast, colorectal, non-small-cell lung, and small-cell lung cancers, and melanoma and leukemia, Maxim said. It's one of more than 40 such families identified by the company through its caspase-based high-throughput screening.

"This [apoptosis] field includes, as we're discovering, a wide range of mechanisms," Stambaugh said, noting that there are "literally hundreds, maybe more" ways to induce cell death.

"We're discovering methods and targets that have never been known before," he told BioWorld Today, focusing especially on caspase-3, "sometimes called the suicide caspase. Once it's induced, cells will go into irreversible cell death."

Reverse engineering makes the Maxim process more efficient, Stambaugh said. "We have a team that's sorting out these mechanisms, working back through a cell all the way to a target," he said.

Under the terms of the Myriad deal, Maxim granted an exclusive worldwide license to the Salt Lake City-based firm for development and commercialization of the MX90745 series. A joint development team made up of personnel from both companies will oversee Myriad's work, and Maxim has agreed to provide research services to Myriad for at least one year.

Myriad is paying license fees, research support and milestone payments totaling up to $27 million (assuming a product reaches the market), along with royalties. The company has its own apoptosis-inducing drug, MPI-176716, which is being tested preclinically for ovarian and other cancers.

Maxim's lead drug candidate, Ceplene (histamine dihydrochloride), just completed a Phase III trial for acute myeloid leukemia, and researchers are evaluating the results. The drug also in Phase II trials for hepatitis C and advanced renal-cell carcinoma.

Ceplene is designed to prevent or inhibit oxidative stress, thereby reversing immune suppression and protecting critical immune cells, and Maxim recently filed for European approval against advanced melanoma. (See BioWorld Today, Nov. 11, 2003.)

Next is an NDA filing for melanoma in the U.S.

"We hope to do that in the second half of 2004," Stambaugh said.

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