Neurorecovery, Inc. Announces Clinical Trial Schedule For 2005

TUSCALOOSA, Ala., Dec. 13 /PRNewswire/ -- Neurorecovery, Inc. (NRI), a patient-focused pharmaceutical and medical delivery system company, today announced its anticipated 2005 clinical trial schedule.

In the first quarter of 2005, NRI, in conjunction with Wayne State University and Johns Hopkins University, expects to begin Phase 1 human trials for its Ventricular Catheter and Main Valve Assembly Kit (cMVA). The catheter, which functions as part of NRI's patented Comprehensive Intercranial Pressure Evaluation and Relief (CIPER) Kit, is designed to monitor and relieve intracranial pressure in patients suffering from neurological injury.

The company also said it anticipates that in the second quarter of 2005 it will have three additional products in various stages of clinical trials. Ampydin (4AP) is currently in late Stage Two human trials for chronic Guillain-Barre syndrome, and an add-on trial for Charcot-Marie-Tooth is being added to the ongoing trial. Stage Three trials are expected to begin in spring 2005.

In addition, both GABAmide and CM-Sal are expected to enter seven-day large animal toxicity studies shortly, with planned IND Human Trials Phase 1 in late spring 2005. GABAmide's study will focus on the amelioration of symptoms for Dystonia, while the CM-Sal study will be for the amelioration of symptoms for pain.

"Neurorecovery's goal is to build an initial portfolio of pharmaceuticals and delivery systems aimed at a segment of the neurological disease and injury market that we see as being significantly underserved," stated Landon C. Miller, president and co-founder of NRI. "We believe we are making good progress, and we are confident that we have targeted the right market at the right time."

Mr. Miller added that that the number of known neurological indications is vast, and that neurological injuries now rank as one of the top five injury types, when measured by cost. He said NRI believes the future of neurological medicine will be based on the integration of FDA-approved pharmaceuticals and delivery systems capable of sterile introduction of such pharmaceuticals.

To achieve its goals, Neurorecovery is attempting to maximize business- development opportunities and financial performance, while avoiding the common entrepreneurial missteps. In focusing on compounds that have already been proven effective in other areas, and concentrating on new ways to deliver those compounds to the brain and spinal cord, NRI hopes to bring a number of new treatments to market in a relatively short period of time, and at a low cost.

"There are certain obstacles unique to treating neurological injuries, and one of those obstacles is the difficulty in delivering drugs to the brain and spinal cord," said Dr. Jay Meythaler, one of the company's co-founders, who now is a member of the NRI's scientific advisory board. "NRI's approach is to look to proven compounds, in analogous situations, and then try to 'parallel' that success with a new delivery approach -- either through an innovative system or as the result of an add-on molecule -- designed to overcome blood- brain or blood-nerve hurdles."

Mr. Miller added that, while seeking to maximize its operating performance, NRI remains committed to addressing important societal matters that revolve around severe neurological injury and disease. NRI was founded in 1998 by Mr. Miller, Dr. Jay Meythaler, and Dr. Jean Peduzzi, a research scientist, after Mr. Miller's son suffered serious neurological injury, and the three persons collaborated in the development of an innovative treatment regimen for Mr. Miller's son.

"Our objective is to save, improve and rebuild lives," stated Mr. Miller. "We want to do good for society while doing well financially."

Neurorecovery, Inc. is a patient-focused pharmaceutical and medical delivery system company whose corporate mission is to enhance drug delivery and enabling methods for patients suffering from neurological injuries and diseases, while addressing important societal issues related to those injuries and diseases. The company intends to achieve its goals by developing and bringing to market low-priced products with a proven efficacy and which meet significant -- and unmet -- medical needs throughout the injury cycle, and by utilizing an innovative business model that integrates academic research, business best practices, and the social needs of the world's population. Neurorecovery, Inc. is based in Tuscaloosa, Ala.

CONTACT: Mike Geczi or Maureen Dempsey, both of APCO Worldwide,+1-212-300-1803

Web site: http://www.neurorecoveryinc.com/