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NovaCal Announces Clearance by the FDA to Commence NVC-101 Clinical Trials in Infected Chronic Wounds
EMERYVILLE, Calif. -- NovaCal Pharmaceuticals, Inc. today announced that the FDA has cleared the company's IND for NVC-101, a novel topical anti-microbial product. Dr. Kenneth Krantz, NovaCal's VP of Medical Affairs said that the company plans to begin Phase II clinical trials at four centers early in 2005. "Our trials are aimed at reducing bacterial infection and improving healing in chronic non-healing venous stasis ulcers, as well as in diabetic ulcers and pressure sores."
Infection in chronic wounds is one of the major obstacles to healing encountered by the five million Americans who suffer for months or even years from these debilitating ulcers, where the use of current topical antiseptic products is discouraged by the U.S. Public Health Service because of their cytotoxicity.
Dr. Behzad Khosrovi, NovaCal's VP of Research and Development explained that the in vitro data submitted to the FDA shows that NVC-101 has a broad anti-microbial profile. In addition, the in vivo safety studies showed an acceptable safety profile. He pointed out that "NVC-101 is quite remarkable because of the speed with which it kills gram positive and gram negative bacteria, including the resistant species of MRSA and VRE that are becoming a major problem in hospitals."
NovaCal Pharmaceuticals, Inc. is developing three small molecule anti-microbial compounds for use in a wide range of potential human and veterinary applications. In addition to NVC-101, NVC-320 is in pre-clinical development and a third compound, NVC-422, is a lead pre-clinical candidate. NVC-320 has characteristics that complement those of NVC-101 and should permit its use in different indications. The company is exploring the potential uses for its compounds in dental applications, including periodontitis, ophthalmic indications, severe burns, surgical and dermatological applications, as well as in mastitis in dairy cows. "With such a wide range of potential uses," said Dr. Ron Najafi, Chairman and CEO, "we are beginning discussions with appropriate partners to take our products into the clinic in these additional indications."
Source: NovaCal Pharmaceuticals, Inc.