GliaMed Inc. is getting a makeover, complete with a new CEO, new company headquarters in the Boston area, a new website that recently went live and - the development that the company perhaps is most proud of - a stem cell-like product for wound healing that is attracting attention from potential investors.
Founded in 2001, the company is focused on developing compounds called regenerative immunophilin ligands, or RILs, that have been shown to regenerate skin and other tissue in animal models.
GliaMed takes a small-molecule approach to stem cell therapy, but avoids the risks associated with reinserting stem cells, newly installed CEO Andrew Uprichard told BioWorld Today. The company is interested in studying its wound healing compound (GM1485) in three patient populations: orthopedic surgery (where wound strength is particularly important), plastic surgery (where scar reduction would be advantageous) and burns (where regeneration of skin would lead to significant reductions in morbidity).
Until now, the company was largely funded through $4.5 million, mainly from grant and angel funding. But the Framingham, Mass.-based company is looking to raise about $15 million in a Series A financing round, and one firm, California-based Quantum Technology Partners, already has signed on as an investor. The vast majority of those funds would go toward development of a topical formulation of its wound healing product candidate, GM1485. With the money it hopes to raise, the company plans to conduct animal efficacy and toxicology studies and a proof-of-concept study in healthy volunteers for the skin indication.
GliaMed, which is considering a name change, was among 37 companies selected from more than 450 applicants to present at the recent BIO National Venture Conference in Boston, where investors gathered to learn about new start-up biotech firms. The company already has performed a number of animal studies, mainly looking at the regeneration of skin. So far, its compound has been shown in animal models to regenerate all components of the skin: hair follicles, blood vessels, sweat glands and nerves.
It plans to repeat the animal studies, including studies in models of pigs, which are considered good models for wound healing. The company would then perform a skin toxicology study in animals. Next, would come a study in healthy volunteers. Although Phase I studies usually are done in healthy volunteers to evaluate safety, GliaMed plans to do a study in healthy volunteers that will look for efficacy, Uprichard said. Data from that study would be expected in the second quarter of 2010. Each patient would serve as his/her own control in the study, where two cuts on the same person would evaluate the drug and placebo.
GliaMed plans to file an application for an investigational new drug for the topical indication by the end of the year, a move that would bring that program a step closer to clinical trials. It has early evidence that its GM1485 compound also can regrow cartilage, nerve tissue in the brain, and liver and heart tissue in animal models. If it can raise enough money, the company is open to parenteral (oral) formulations for other indications such as heart attack or stroke, and local injections for cartilage in patients with osteoarthritis in the hip or knee.
But for now, the company is focused on the topical formulation, for which it already has generated quite a bit of preclinical data. The topical indication could allow the company to get proof-of-concept data very quickly, Uprichard said. And the study in healthy volunteers would be relatively inexpensive compared to more costly studies in heart attack and stroke patients, for example.
Currently, there is no pharmaceutical product approved for regeneration of the skin, though there are dressings that claim to reduce scarring. Uprichard noted that ReNovo plc, of Manchester, UK, has a product for reducing scarring, but there has been some negative data indicating that scars re-open.
GliaMed had its own class of compounds with regenerative properties, but in 2007, Uprichard said, the company "got a shot in the arm" when it acquired the portfolio of Guilford Pharmaceuticals Inc.
Guilford was acquired by MGI Pharma Inc., which sold the portfolio to GliaMed. Guilford sought to develop a drug with regenerative properties, without the immunosuppressant activities seen in another compound by Fujisawa (FK506).
Guilford's compound, which was renamed GM1485, had been studied in two large Phase II studies that had negative results. But GliaMed founder David E. Weinstein believed that he understood what went wrong in the Guilford program. Weinstein, who serves as chief scientific officer of GliaMed, believes that inflammation is required for the compound to work and that its mode of action is similar to that of pluripotent stem cells.
One of Guilford's Phase II studies was in post-prostatectomy patients with erectile dysfunction, and the other was in Parkinson's disease. More than 500 patients received the drug in the two Guilford trials, about 100 received drug for two years or more.
Finding ways to heal wounds by returning them back to their original state with little or no scarring is an active area of research, said Thomas Serena, a vascular surgeon and wound healing expert who serves on the GliaMed clinical advisory board. But currently, he said, there is nothing on the market that actually results in regeneration of the skin, or any other tissue. "That is our new horizon and that is where we are headed," Serena said.
GliaMed's molecule stimulates the regenerative process, acting similar to stem cell therapy and signaling cells to regrow hair follicles and nerve cells, for example, Serena explained.
The company has a virtual staff of five employees, including Uprichard, who came on board in January. Prior to joining GliaMed, he served in various executive positions at ArQule Inc., Curis Inc. and EPIX Pharmaceuticals Inc., where he secured approval of Vasovist after a series of appeals.
The company's board includes investors Barry Dickman, founder and managing director of Quantum Technology Partners, and Andrew Busser, co-founder and principal of Symphony Capital LL. Also serving on the board are Uprichard and Weinstein, who is an internationally recognized expert in the areas of multiple sclerosis, brain tumor research and spinal cord and nerve regeneration.