Cellcor receives FDA OK to proceed with treatment IND for autolymphocyte therapy in metastatic renal cell carcinoma.NEWTON, Mass.--(BUSINESS WIRE)--Sept. 22, 1995--Cellcor, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). :CLTX) announced today that Cellcor's treatment for stage IV metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. (MRCC MRCC Metastatic Renal Cell Carcinoma MRCC Micro RC Center MRCC Maritime Rescue Coordination Centre MRCC Montana Raptor Conservation Center MRCC Movement Report Control Center MRCC Medical Regulating Control Center ) will be available to the medical community through a Treatment Investigational New Drug (IND) Program. The Treatment IND program will allow autolymphocyte therapy (ALT), an immunotherapy which uses a patient's own immune cells to treat disease, to be available as a treatment option to patients with MRCC who were not able to participate in ALT clinical trials. This is the first Treatment IND granted by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for a somatic cell-based therapy. Ronald J. Brenner, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cellcor, stated, "Because patient accrual for the ALT Phase III pivotal trial is finished and the clinical development of this product is complete, the Treatment IND is very important, as there would otherwise be no mechanism by which patients with MRCC could access the ALT treatment." Cellcor expects to begin patient accrual for the Treatment IND in fourth quarter 1995. The Treatment IND also allows Cellcor to charge patients for the cost of the treatment. Treatment IND Programs represent an effort by the Food and Drug Administration (FDA) to make investigational drugs available for the treatment of patients with a serious or immediately life-threatening disease. For investigational drugs to be eligible for a Treatment IND Program, there can be no comparable or satisfactory alternative drug or other therapy available to treat the particular disease in the intended patient population. As previously announced, Cellcor and CYTOGEN Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CYTO CYTO Croydon Youth Theatre Organisation (UK) ) have signed a merger agreement, which both companies expect to complete in October of this year. ALT will be available through the Treatment IND Program which Cellcor and CYTOGEN continue to monitor the patients from the Phase III pivotal trial, prepare an application for submission to FDA and pursue marketing approval of ALT. Cellcor and CYTOGEN emphasize that no assurances can be given regarding the timing or outcome of any applications they intend to submit to FDA. CYTOGEN is a biopharmaceutical company engaged in the development and marketing of products for the targeted delivery of diagnostic and therapeutic substances directly to sites of disease. CYTOGEN uses its patented and proprietary technologies to develop specific cancer diagnostic imaging and therapeutic products. Cellcor, Inc. is a biotechnology company engaged in the development of cellular therapies with initial application in the treatment of metastatic renal cell carcinoma and potential application in the areas of infectious disease, such as chronic hepatitis B. Physicians who would like more information about the ALT Treatment IND program can contact the clinical services manager at Cellcor at 1-800-441-7901. CONTACT: Cellcor Inc., Newton Ronald J. Brenner, 617-332-2500 |
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