October 19, 2011

State of Alabama
Press Release: Alabama Department of Commerce

HudsonAlpha Companies Say They Are Near Breakthroughs In Breast Cancer Fight

Randall Moreadith
Dr. Randall Moreadith, with Serina Threapeutics, in the lab at the Hudson-Alpha Institute for Biotechnology Serina Therapeutics is developing a polymer which will keep cancer medications in the human body longer.
(The Huntsville Times/Eric Schultz)

HUNTSVILLE-- Two small companies at Huntsville's HudsonAlpha Institute for Biotechnology are preparing to test new products in 2012 that could advance the fight against breast and other cancers.

In one case, the product itself is a comprehensive lab test to help physicians decide which drugs would be most effective, or least effective, for particular cancer patients. This would be a step toward the anticipated coming era of "personalized" medicine. The second product is a new drug delivery system that its developer believes "could offer the chance of a cure..."

The company holding out the possibility of a cure for some cancers is Serina Therapeutics, a small (nine-person) privately held company based on the HudsonAlpha campus in Huntsville's Cummings Research Park.

Nurturing small companies such as Serina is one of HudsonAlpha's missions, which also include education and research.

Serina has developed a new polymer - "nothing more than a repeating unit of the same small molecule" - that can target and deliver cancer drugs directly to cancer cells, according to Dr. Randall Moreadith, president and chief executive officer.

Moreadith is a Duke University-trained physician with a doctorate from Johns Hopkins University. He was a post-doctoral fellow at Duke and Harvard University's medical school and came to Serina from Nektar Therapeutics, which has developed similar polymer-based drug delivery systems.

Moreadith said Serina's polymer is a chain to which cancer drugs can be attached for long-term treatment.

"Current chemotherapy, as it exists today and as it has existed for the last 60 years since the first anti-cancer drug was introduced, is limited by what we call pharmacokinetics (the effect the body has on the drug)," Moreadith said in an interview in early October. "These molecules that we use to treat cancer have a very short half-life in the body ... minutes to hours.

"So, when you give a dose of a cancer drug, you give a whopping dose," Moreadith said, "and you try to kill as much of the cancer as possible so you don't kill the patient or harm the patient, and then you wait for the body to recover from that, typically several weeks, and then you bring them back again and give them another whopping dose. This is how we treat cancer."

The problem is that the drug isn't active and killing cancer cells while the body is recovering, and the cancer cells that remain, which resisted the initial treatment blast, are now dividing and growing. This is an excellent way to develop resistant cancers.

The same phenomenon occurs with antibiotics, Moreadith noted.

The polymer system keeps the cancer drug in the body for much longer at a dose sufficient to keep killing cancer cells while not harming the patient. This is the system Nektar believes it has developed, based on current laboratory tests, and what Serina believes it has developed, as well.

"It is a 'wow,'" Moreadith said. "It is truly a 'wow.'"

What Serina has that puts it "one up" on Nektar, Moreadith said, is the ability to target its longer drug-laden polymer directly at cancer cells.

Cancer cells have numerous "receptors" for the B vitamin folate on their surface, he said. Folate, or folic acid, as it is also known, is required for proper cellular division.

"We're going to take advantage of that (receptor)," Moreadith said. "We're going to couple folic acid to the end of our polymer to see if we can trick the cancer cell into taking up the folic acid. It thinks it's taking up folate to divide. It's actually taking up our polymer payloaded with a potent anti-cancer drug."

Tests have been successful with laboratory mice, Moreadith said. In early 2012, Serina expects to be testing its polymer drug delivery system directly on human patients in a phase 1 clinical trial at Huntsville's Clearview Cancer Institute.

"I think our drug is a general cancer drug," Moreadith said. "It might be particularly effective in a particular genetic group of patients, but that's not what we do. We're developing a drug, our lead clinical candidate, that would be broadly applied against cancer."

The company encountered "minor setbacks" this year in scaling up production of its polymer to the quantities needed for clinical testing, Moreadith said, "but I think we'll get there."

In the meantime, another HudsonAlpha-based company - Kailos Genetics - is also preparing for clinical trials next year on its new genetic test designed to give oncologists a faster read on a patient's genetic susceptibility to all of the available cancer medications on the market.

By focusing specifically on the genes already implicated in cancer, and ignoring the remaining 97 percent of the humane genome, Kailos chief strategy officer Michael Walters said this month "we're able to turn the result in certainly no more than five business days."

"The paradigm shift is that we, as a company, are not focused on a specific drug," Walters said, "but we are trying to help oncologists begin to look at all the potential variants that are known and linked to drugs in a single test . ... Because we can test for everything, we can test right after the diagnosis. Not having to wait, we think, is extremely important."

"Our goal is a day" to test the patient sample, Walters said. Add a day to receive and return it, and results could get back to physicians in 48 hours or so - soon enough to make key decisions about treatments within days of diagnosis.

Won't such testing be expensive? It's relative, Walters believes. With the cost of a course of cancer drugs reaching the tens of thousands of dollars, prescribing a therapy that doesn't work or that causes severe side effects has its own costs.

Drug companies "are realizing the success of their products is tied to finding the population that responds well ...," Walters said. "The day of blockbusters is behind us."

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