Baltimore-based Arcion's top pain management product candidate

Daily Record, The (Baltimore), Jan 14, 2008 by Karen Buckelew

Arcion Therapeutics had an unusual advantage over most young drug companies as it conducted its first round of venture capital fund raising.

Its lead product candidate, a topically applied experimental pain reliever, already had proven safe in years of testing involving 600 human subjects.

Most early stage firms -- Arcion was founded in Baltimore just last summer -- still are waiting to test their drugs in humans.

But founder and CEO Dr. James Campbell has shepherded Arcion's technology down a long path since discovering its potential in 1998.

Campbell, a Johns Hopkins neurosurgeon and pain expert, seems determined to bring relief to the millions of diabetics who cope with diabetic neuropathy -- chronic pain caused by nerve damage related to low blood sugar.

It's why he founded the American Pain Foundation in Baltimore in 1997, and why he serves as an entrepreneur-in-residence to InterWest Partners of Menlo Park, Calif.

InterWest is one of the two venture firms that joined in Arcion's first round of funding, which raised $8.8 million last year. The other is CMEA Ventures, also in Menlo Park.

Campbell also has played an integral role in two other drug companies. Anesiva Inc., based in San Francisco and traded on the Nasdaq as ANSV, was founded in 2001 on a Campbell discovery.

And as a board member, he has helped to shepherd Baltimore firm Amplimmune Inc., which works to treat immunological conditions, through a $20 million early round of investment. InterWest invests in that company as well.

"It's not enough to just discover things," Campbell said. "If you don't have the passion to take things forward, they just sit. They don't go anywhere."

Arcion was started to capitalize on Campbell's discovery that a drug already approved for the treatment of hypertension could ease the pain, usually in the feet and legs, caused by diabetic neuropathy.

While at Hopkins, he patented the use of the substance, called clonidine, for treating pain, and since has patented a topical gel formulation that allows patients to apply it to the skin where the pain occurs.

As many as 60 percent of diabetics suffer from neuropathy, according to Greater Baltimore Medical Center endocrinologist Dr. James Mersey.

The pain can disrupt patients' lives and can spread to the hands and arms, he said.

"The treatments for painful neuropathy have not been terribly great," Mersey said. "Half my patients get some relief, but it never makes it go away."

Typical treatments include the drugs Lyrica, Cymbalta, Neurontin or narcotics. The first three boast annual sales in the billions of dollars.

But their effectiveness is limited, Mersey said, and side effects include dizziness, nausea and fatigue.

Arcion's clonidine-based therapy locally delivers very low doses of the drug. It shouldn't affect the patient's entire system, and Campbell said he believes it won't cause side effects or interact with other drugs.

"We've already gotten positive results in prior trials," said Kerrie Brady, Arcion chief operating officer.

Campbell had licensed the drug to Curatek Pharmaceuticals, an Illinois firm that performed all the previous human tests. Curatek gave up those rights in 2001, Campbell said, because of the economic conditions after that year's terrorist attacks.

Arcion is gearing up for a Phase IIb trial, set to begin this quarter and to last about 18 months. The company's new venture money should pay for those tests, Brady said.

But first, the federal Food and Drug Administration has to approve the therapy for human testing -- its previous clearance for the drug has lapsed.

Arcion's lead product candidate is no cure for neuropathy, Campbell said. Controlling the blood sugar can stop the spread of the pain, but there is no way to reverse the symptoms.

But patients are desperate for a little relief, he said, noting the multibillion dollar market for existing treatments.

Mersey agreed.

"These patients are very needy," he said. "We have very little to offer them."