AmpliMed Corp.'s pipeline of cancer drugs continues to grow, with the addition of a portfolio of preclinical compounds, including FB642, which has shown early promise as a cancer product.

The Tucson, Ariz.-based company licensed the compounds from UAF Technologies and Research LLC (UTR), a technology transfer unit of the University of Arizona Foundation. As part of the agreement, AmpliMed will take over development of FB642, while UTR will be entitled to equity in AmpliMed, along with milestones and royalties.

FB462 (carbendazim), which is set to begin Phase I studies early next year, originally was developed over seven or eight years by Cincinnati-based Proctor & Gamble Co., said Robert Ashley, president, CEO and chairman of AmpliMed.

The compound and its derivatives "were subjected to an extensive screening process and actually taken into the clinic by P&G," he told BioWorld Today. But that early oral formulation had some "solubility problems," requiring patients to ingest large quantities to reach the necessary blood levels, he added.

Proctor & Gamble stopped development of FB462 after Phase I, and in 2003 decided to donate the compound, along with intellectual property and other assets, to the University of Arizona, which later established UTR to manage this portfolio.

"That's how we got access to it," Ashley said. AmpliMed, which was founded with support of the university and the approval with the Arizona Board of Regents, maintains "a very close relationship with the university."

That relationship helped secure the licensing deal, he added. "There were others certainly looking at [FB642] but our close collaboration was key, as was [the university's] desire to keep the technology here in the Tucson area."

The company became interested in the compound when researchers developed a new formulation that allows oral bioavailability of about 75 percent, as opposed to the paltry 5 percent bioavailability of the first version. With that new formulation, AmpliMed also has gained data from the early testing by Proctor & Gamble, including safety information and details of the drug's mechanism of action as a promoter of apoptosis.

"We've got two rooms full of paperwork," Ashley said, and a still-open investigational new drug application that is being transferred to AmpliMed that likely will require only "a simple amendment before we're able to back into the clinic."

FB642 and its derivatives also have shown early clinical activity as an antiviral, making it a potential therapeutic in HIV infection. However, since AmpliMed's focus is cancer, the company might consider sublicensing the compound's antiviral properties.

It is the third product the company has gained through its relationship with the University of Arizona. Amplimexon (imexon injection), which had been studied years ago as a potential therapeutic, was rediscovered at the university by researchers later involved in AmpliMed. And the company's azonafide class of compounds, led by Amplizone, was developed by researchers working in collaboration with AmpliMed.

Amplimexon, which has received orphan drug status in the U.S. for malignant melanoma, multiple myeloma and pancreatic cancer, and orphan status in Europe for pancreatic cancer, is finishing up a Phase I study to determine the maximum tolerated dose. The drug also is in two ongoing Phase I/II trials to evaluate it in combination with dacarbazine for malignant melanoma and in combination with gemcitabine in patients with untreated pancreatic adenocarcinoma. Other studies are planned to test Amplimexon in multiple myeloma and in combination with Taxotere to treat lung, breast and prostate cancers.

The company is in the last stages of preclinical development with Amplizone. Phase I trials are expected to begin near the start of the second quarter of 2006.

Ashley said AmpliMed is pursuing potential partnerships for areas outside the U.S., but that most of the focus "at the moment has been on fully exploring the compound" and its mechanism of action.

Because it operates as a virtual company, AmpliMed has been able to complete early development work without burning through a lot of cash. To date, the company has raised about $14 million, including a $5 million Series B round that closed in June. Ashley said the Series B was oversubscribed and the company soon would release final closing proceeds.

"We're doing a lot of development work with the university and we've gotten [Amplimexon] into the clinic mostly on [National Cancer Institute] grant money," he said.

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