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Cyplasin Biomedical Ltd enters negotiations with manufacturing organizations for scale up and GMP manufacture of Cyplasin-SC
Edmonton, Alberta, November 16, 2007
CYPL: OTCBB, Frankfurt Exchange WKN:XYIA
Cyplasin Biomedical Ltd today announced today it has initiated talks with various Contract Manufacturing Organizations (CMOs) from Eastern Europe, Germany, Switzerland and the United States for the continued manufacture and scale-up manufacturing process of Cyplasin-SC. Once the scale-up manufacturing protocol is in place then we will also be able to produce Cyplasin-SC under Good Manufacturing Practice (GMP) guidelines.
“We need to be able to scale up the manufacture of Cyplasin-SC now in order to be able to complete our late stage preclinical toxicology efforts and then be able to produce it under GMP guidelines for our human clinical studies later on” stated Garth Likes, President & CEO. He further stated that “being able to produce under GMP guidelines is mandatory for various worldwide regulatory authorities such as the FDA.”
GMP guidelines are designed to assure that consistent high quality manufacturing procedures are followed and maintained for all therapeutic drug products. GMP, for example, ensures correctness and legibility of recorded manufacturing and control documentation and that data transfers are performed in specific ways to avoid manufacturing mistakes.
All of the CMOs selected for talks have been pre-screened for their ability to meet the required GMP guidelines and are qualified to manufacture cyplasin accordingly. A decision by the company on the final selection of a manufacturer is expected in the upcoming weeks.
About Melanoma
Around 160,000 new cases of new melanoma cases are diagnosed worldwide each year. Melanoma is more frequently found in Caucasian males and is more common in Caucasian populations living in sunny climates than in other groups. Market statistics for skin cancer and melanoma show that melanoma currently affects more then 2.4 million people worldwide with 62,000 new cases being reported in the USA every year. Australia has the highest rate of melanoma in the world among males and has the second highest rate in the world among females (Australia’s Health 2004, AIHW). According to the WHO Report the world wide incidence has doubled over the past 20 years with about 48,000 melanoma related deaths occurring worldwide per annum.
About Cyplasin-SC
Cyplasin-SC has demonstrated a selective ability to rapidly kill certain types of cancer cells while leaving normal non-cancerous cells untouched. Cyplasin-SC is a protein originally discovered and isolated by Professor Petzelt from a marine organism, the sea hare (Aplysia punctata). The protein can now be manufactured as a recombinant protein which allows the company to develop the protein as an anti-cancer therapeutic product. Patents have been issued to the Company covering the Cyplasin-SC protein.
About Cyplasin Biomedical Ltd. (CBL)
Founded in 2007 and headquartered in Edmonton, Canada with a research laboratory close to Berlin, Germany, CBL is dedicated to bringing new anticancer therapeutics to the marketplace. The Company’s current goal is to develop and commercialize the anticancer properties of Cyplasin-SC against skin cancer and melanoma. CBL is publicly traded (CYPL: OTCBB)
Forward-Looking Statements
This Press release includes and is based, inter alia, on forward-looking information and statements that are subject to risks and uncertainties that could cause actual results to differ. Such forward-looking information and statements are based without limitation, as statements regarding future drug development activities, anticipated products, or anticipated future revenues, benefits or advantages, and the future plans and objectives of the Company, that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company's control, such as market acceptance of new products and services, changes in governmental regulations, interest rates, fluctuations in currency exchange rates and such other factors as may be discussed from time to time that may cause actual results or performance to differ materially from those currently anticipated in such statements. These expectations, estimates and projections are generally identifiable by statements containing words such as "expects", "believes", "estimates" or similar expressions. Although Cyplasin Biomedical Ltd., believes that its expectations and the information in this Press release were based upon reasonable assumptions at the time when they were made, it can give no assurance that those expectations will be achieved or that the actual results will be as set out in this Press release. Cyplasin Biomedical Ltd., makes no representation or warranty, expressed or implied, as to the accuracy, reliability or completeness of the information in the Press release, and neither Cyplasin Biomedical nor any of their directors, officers or employees will have any liability to you or any other persons resulting from your use of the information in the Press release. The OTCBB Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release.
Contact:
Garth Likes
President & CEO
Cyplasin Biomedical Ltd.
www.cyplasin.com
Direct phone +1.780.469.CYPL(2975) FAX number +1.780.699.7933
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