AmpliMed Corp., having closed its Series A round in May, is preparing for clinical development of its lead cancer drug, Amplimexon, which it hopes will one day provide therapy for pancreatic and other cancers.

AmpliMed, of Tucson, Ariz., was founded in 1991, with the help of the University of Arizona Technology Development Corp., by four individuals who worked at the university: Evan Hersh, David Alberts, Robert Dorr and William Remers.

"The company's gone through a lot of different forms, I think, over the years," Chairman, CEO and President Robert Ashley told BioWorld Today. "It was originally a company that was developing antiviral formulations [or] liposomal formulations of antiviral drugs."

Hersh, Dorr, Remers and Albert had founded "a number of different companies," he said.

Ashley, who once was senior vice president of commercial development at Collagenex Pharmaceuticals Inc., of Newtown, Pa., joined AmpliMed in January.

AmpliMed raised about $9.3 million in Series A funds in two parts beginning last September and wrapping up in May. Led by Valley Ventures III, the company's first institutional round of investors included Biotech Insight Management, of Pebble Beach, Calif.; Invest Bio, of New York; Solstice Capital, of Tucson; and others.

The money is being used primarily for the development of Amplimexon, a drug Ashley said has "been around for a long time."

"It was at Boehringer Manheim as an immunostimulatory drug," he said. "It was developed at one time as a way of stimulating depressed immune systems, or compromised immune systems. But, as well, it was observed to have some potential as an anticancer drug and actually was studied in people back in the [1980s] by a group of physicians in Austria as an anticancer drug."

Amplimexon is Imexon for injection. The four founders of AmpliMed "sort of rediscovered the drug" in the mid-1990s as a result of research they conducted on AIDS. Not only did they work to discover its mechanism of action and "clarify the utility of the drug as a cancer drug," but also they developed many derivatives of the compound, Ashley said.

The drug appears to deplete glutathion and disrupt mitochondria, and eventually induce apoptosis. Ashley said it "seems to be a mechanism which isn't susceptible to the normal resistance mechanisms."

The company is set to begin a "classic" Phase II in the fourth quarter in pancreatic adenocarcinoma with the drug as an adjunct to gemcitabine, he said.

"It turns out that at least the animal data that we have demonstrate a spectacular synergy [between Amplimexon], and gemcitabine," Ashley said. "And cell lines and implanted tumors, which are completely resistant to gemcitabine, which is the majority of pancreas tumors, of course, become highly susceptible at even relatively low doses of Imexon."

In addition to the Phase II study in pancreatic cancer, AmpliMed is scheduled to begin a pilot study in myeloma, as well as another Phase I with gemcitabine in lung cancer. That trial is scheduled to begin in the fourth quarter

The company also has Amplizone, which is about a year away from the clinic and is one of a group of azonafides developed by Remers based on a compound called amonafide, which is being developed by Xanthus Life Sciences Inc., of Cambridge, Mass.

Amonafide, a site-specific DNA-intercalating agent and topoisomerase II poison, already has been studied in Phase II trials by the National Cancer Institute in Bethesda, Md., which tested its hydrochloride salt form of the drug against metastatic breast cancer. (See BioWorld Today, Dec. 15, 2003.)

Ashley is using the same "virtual development" model at AmpliMed that was used at CollaGenex, a company that went public with only five employees in June 1996. At the time of the last leg of the $9.5 million financing, AmpliMed had seven employees. (See BioWorld Today, June 21, 1996.)

"We exploit third parties and academic resources in the company, so while there are not that many employees in the company, there are 20 to 30 people who are actually working one way or another on our drugs as a result of contracts or extramural collaborations of one kind or another," he said.

As for the company's business strategy, what the company pursues will in part be dependent on the efficacy that is determined by clinical trials, although Ashley said "it's not unreasonable for the company to get a product to the market by itself," unless additional Phase II and Phase III work is required.

"So, there are really only two strategies you can adopt," he said. "One, if the world sort of goes in your direction very favorably, maybe you can take the company public and raise sufficient capital to be able to do a Phase III study. But much more likely, you find a partner of some kind, and that partner does the Phase III study with you."

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