When Italian chemist Ascanio Sobero discovered nitroglycerin, he could never have envisioned a promising future for an explosive chemical that left him badly scarred. Even when Alfred Nobel stabilized the glycerin compound and created a silica, dynamite, Sobero was convinced no good could come of it. Almost two centuries later, nitroglycerin is known for its pain relief properties. Still, one can hardly resist suggesting that Procris Pharmaceuticals has come up with a “dynamite” idea with breakthrough therapies using an aqueous form of nitroglycerin. With careful targeting, the drug is used to treat diseases with underlying vascular deficiency. Already, the formula is in phase II for treating pain associated with diabetic peripheral neuropathy. Matt Gonda, CEO of Procris, says the drug, applied directly to problem circulation areas, will not only relieve the discomfort associated with numbness or “pins and needles” pains, but it also could restore better mobility to some diabetics. “We’re a very unusual company in that we are utilizing known chemicals that have been around and are FDA-approved,” said Gonda. “The effect of these drugs is well understood, but we are finding new ways to apply them in targeted therapy.” Gonda said the beauty of the targeted therapy is its simplicity. The concept that jumpstarted Procris was to increase the efficacy of drugs through targeted delivery, and the nitroglycerin compound has multiple indications — all related to vascular insufficiency. Taking a pill orally sends the drug through the bloodstream, affecting the body and becoming diluted as it moves through the system before it treats the problem. “If you put the topical formula on the foot, it works only on the foot,” Gonda said. “The key is finding a way to appropriately apply the drug. We formulated a soluble cream that goes in fast and is gone.” Procris developed from International Medical Innovations (IMI), but IMI underwent a complete transformation — basically a restart — said Gonda, who has a doctorate in molecular oncology from Johns Hopkins University. The company is named for a figure from Greek mythology, Procris, who received two gifts from Diana, goddess of the hunt. One was a dog, faster than any prey, and the other was a spear that always flew true to its target. “She was given a magic spear that never missed its mark,” Gonda said. “That’s what targeted therapy is for. We never miss our mark. It is a great name, because it appropriately brands the company.” Procris’ first product went into clinical trials last year and is close to completion, promising relief for sufferers of neuropathy. “In terms of enrollment, the last patient will come out of trials by the middle to end of March, and the data will be analyzed and ready to be examined by the FDA,” Gonda said. “We’re almost ready for phase III. Our investors have been very good to us. As long as we keep hitting clinical milestones, they will continue to invest in the company.” Because Procris is reformulating drugs, Gonda said, development time is shorter, and most trials start at phase II — nearer the end-stage of testing. With the drug as a known quantity, Gonda expects more rapid approval from the FDA. “With poor blood flow, the nerves are starved of oxygen,” Gonda said. “If you increase the blood flow, you get oxygen to the nerves and improve the performance of the nerve. Many patients talk about tingling when they first feel the nerve coming back. Then, they feel pain. But when the nerve comes back, it’s easier for them to sleep and easier for them to get around.” The aqueous drug, IMX-150, is in a double-blind, placebo-controlled phase II clinical trial that began on Sept. 1, 2007, and has had 70 patients enrolled. Of those, 40 have completed treatment, 30 are still in treatment and an additional nine patients are undergoing pre-enrollment screening. Gonda anticipates the launch of a phase III development program in September, with the drug moving into the approval process at the end of 2009. While the drug promises to improve quality of life for diabetics, it also will help patients with Raynaud’s disease, a circulatory disorder with 25 million sufferers. A phase II clinical trial for treating Raynaud’s may begin soon, and the disease represents a $500 million market nationally. Because Procris’ method makes drugs more adaptable, the market for the drug, and the company, is more than promising. “There are a million applications for it and huge profits to be made,” Gonda said. “There’s very little out there like it. We treat the cause. It’s not only making it more convenient, but more efficacious with fewer side effects.” Procris’ next project likely will target treatment in the brain. “Blood flows to the brain through a capillary network, and the brain only lets certain things in,” Gonda said. “It selectively makes what it wants and keeps it there. Dopamine is made in the brain to treat the brain. If you inject it in the body, it doesn’t go to the brain. You have to trick the brain to let it in.” Combining dopamine with a simple sugar, either in a pill or injection, disguises it, getting it past the brain’s gatekeeper. Using their delivery method, Gonda said Procris is working to target a spectrum of illnesses ranging from Parkinson’s disease to eating disorders. “We’re in at a good time,” Gonda said. “We’re at the forefront of the best treatment. It’s an exciting opportunity.” Parkinson’s therapies are a multi-million-dollar market, and Procris aims to take a share. Researchers have synthesized a form of dopamine (IPX-750) with a simple sugar added. It has been tested in multiple animal models and shown to reduce the symptoms of Parkinson’s disease. Gonda hopes to have the drug in a clinical test setting early in 2009. “Our investors right now are very happy with the company being private. We’ve raised more than $27 million in capital so far, and we have a group of investors (pledging) another 20 million up through 2010.” Gonda said the future might hold an IPO or reverse merger, but at this juncture, Procris is keeping its options open. “Small pharmaceutical companies are also products in themselves,” Gonda said. “They have grown not only to have products but to become a product that big pharmaceutical companies are interested in.” Diabetic peripheral neuropathy pain is a $1 billion market in the United states alone. “Our investors are sold on the technology and what we can do,” Gonda said. Gonda says the goal is to build a company that specializes in creating novel therapies for unmet medical needs. Use of a known hastens its path to the market, and the truncated time frame will save on costs. “The cost is high to develop drugs, and they are getting more and more stringent every year on top of Sarbanes-Oxley,” Gonda said. “It’s almost prohibitive for a company to continue on, but this will go all the way. Even if something better comes along later, we will always be an adjunct, because we treat the cause that makes the symptoms. And that relieves the pain. Some drugs make you feel good about the pain, but they don’t treat the cause.” March 2008