LA JOLLA, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Immunosyn Corporation (OTC Bulletin Board: IMYN) today announced that Biozyme Laboratories has received approval from the MHRA to import base material and manufacture SF-1019 for human use in clinical trials. SF-1019 is a biopharmaceutical for which Immunosyn holds the exclusive license for worldwide marketing rights.
The "Medicines and Healthcare products Regulatory Agency," more commonly known as the MHRA, functions in the United Kingdom on behalf of the European Medicines Agency (EMEA) much like the FDA does in the United States. MHRA regulates which drugs are safe and effective for use in humans to treat specific ailments and conditions. The license approvals currently granted by the MHRA include a "Manufacturer's Authorisation -- Investigational Medicinal Products" (MIA(IMP)) as well as "Manufacturer's / Importer's Licence" (MIA) for manufacturing investigational medicinal products for use in humans for phase I, II and III clinical trials. If a company successfully completes these trials it can apply for a full license to distribute throughout the European Union.
"The fact that SF-1019 has garnered manufacturing and import approval from the MHRA so rapidly is exciting news," says Stephen D. Ferrone, CEO and President of Immunosyn, "as every milestone we achieve in this process brings us that much closer to producing revenue for our shareholders."
"This is another example whereby Immunosyn's shareholders strongly benefit from our unique relationship with our largest shareholder, Argyll Biotechnologies," stated David Criner, CFO of Immunosyn. "Under the terms of our exclusive license agreement, Argyll Biotechnologies is responsible for all regulatory approvals and clinical trials including those required by the MHRA and FDA together with their associated costs."
Under EMEA requirements, in order to obtain approval to manufacture a drug for use in humans, whether for clinical trials or for general use, an approved manufacturer must be able to demonstrate its ability to comply with the rules governing "Good Manufacturing Practice" (GMP) and apply directly to the MHRA for license approval. Following a series of manufacturing "scale-up" studies, Argyll Biotechnologies entered into an agreement with Biozyme Laboratories Limited to manufacture SF-1019. As a result of this agreement, Biozyme applied for and received manufacturing and base materials import approval from MHRA for clinical trials of SF-1019.
About Biozyme Laboratories Limited
Biozyme specializes in the purification of enzymes and related biochemicals (from microbial, animal and plant tissues), using a variety of sophisticated extraction and filtration techniques. The company has two high-specification facilities, both located in the United Kingdom. Products manufactured by Biozyme are currently being distributed worldwide.
About Immunosyn Corporation
La Jolla, CA-headquartered Immunosyn Corporation (IMYN.OTC.BB) plans to market and distribute life enhancing therapeutics. Currently, the company has exclusive worldwide rights from its largest shareholder, Argyll Biotechnologies, LLC, to market, sell and distribute SF-1019, a compound that was developed from extensive research into Biological Response Modifiers (BRMs). Argyll Biotechnologies, LLC has initiated the process for regulatory approval of SF-1019 in several countries and preparations for clinical trials are underway in both the US and Europe. Research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetic Mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders such as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Reflex Sympathetic Dystrophy Syndrome (RSD or RSDS). (For more information on Immunosyn and SF-1019 go to http://www.immunosyn.com).
The above news release contains forward-looking statements. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and are subject to a wide range of business risks, external factors and uncertainties. Actual results may differ materially from those indicated by such forward-looking statements. For additional information, please consult the Company's most recent public filings and Annual Report on Form 10-K for its most recent fiscal year. The Company assumes no obligation to update the information contained in this press release, whether as a result of new information, future events or otherwise.
|SOURCE Immunosyn Corporation|
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