Hard To Treat Diseases (HTDS) Clinical Trials of Nutriprotein
SHENZHEN, China, April 7, 2009 /PRNewswire-FirstCall via COMTEX/ -- Hard to Treat Diseases (HTDS) www.htdsmedical.com - Today, after the market closed the company announced that its clinical trials of its Cerebroprotein Hydrolysate for Injection (Brand Name: Nutriprotein) have begun in India.
Indications: For traumatic brain injury and cerebrovascular disease sequelae associated with the memory impairment and focus on the obstacles to improved symptoms. Nutriprotein is used in treatment for improving the skull trauma and symptom of amnemonic cerebral angionosis sequelae and allomnesia.
Terry Yuan HTDS CEO said "The Company recently received an Import License for the clinical samples. The Multicentric trial is proceeding in India smoothly. Multicentric trials are the third and final phase of clinical trials in India. These are trials on large number of patients of both sexes usually in comparison with a standard drug and / or a placebo if a standard drug does not exists for the disease under consideration. Permission for marketing of the drug is granted on successful completion of this phase.
The Indian Council of Medical Research has laid down special guidelines for clinical trials of drugs and medical devices. There is a proposal for establishment of Indian Medical Devices Regulatory Authority, which will regulate the quality control and marketing of medical devices in India. Once established, the system will encourage national and international marketing of medical devices".
Management anticipates that the clinical trial will be finished as early as July, 2009. Registration and approval is expected to be obtained shortly thereafter, based on positive clinical trial results.
According to HTDS research, the company believes that it is currently the only supplier of this product in the market. It has been estimated that the market size for this product is about 2-3 million dosage units each year and will show continued long-term growth.
The company will provide further details as they become available
