SHENZHEN, China, April 7 /PRNewswire-FirstCall/ - 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.
Safe Harbor Statement
Information in this news release may contain statements about future expectations, plans, prospects or performance of Hard To Treat Diseases Inc that constitute forward-looking statements for purposes of the safe harbor Provision's under the Private Securities Litigation Reform Act of 1995. The words or phrases "can be," "expects," "may affect," "believed," "estimate," "project," and similar words and phrases are intended to identify such forward-looking statements. Hard To Treat Diseases Inc cautions you that any forward-looking information provided by or on behalf of Hard To Treat Diseases Inc is not a guarantee of future performance. None of the information in this press release constitutes or is intended as an offer to sell securities or investment advice of any kind. Hard To Treat Diseases Inc's actual results may differ materially from those anticipated in such forward-looking statements as a result of various important factors, some of which are beyond Hard To Treat Diseases Inc's control. In addition to those discussed in Hard To Treat Diseases Inc's press releases, public filings, and statements by Hard To Treat Diseases Inc's management, including, but not limited to, Hard To Treat Diseases Inc's estimate of the sufficiency of its existing capital resources, Hard To Treat Diseases Inc's ability to raise additional capital to fund future operations, Hard To Treat Diseases Inc's ability to repay its existing indebtedness, the uncertainties involved in estimating market opportunities and, in identifying contracts which match Hard To Treat Diseases Inc's capability to be awarded contracts. All such forward-looking statements are current only as of the date on which such statements were made. Hard To Treat Diseases Inc does not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
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