Navigation Links
Immunosyn Announces Biozyme Lab's Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019
Date:11/28/2007

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
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Immunosyn Corporation Releases SF-1019 Study Results
2. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
3. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
4. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
7. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
8. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
9. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
10. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
11. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... BERLIN , April 29, 2016 ... world-leading glyco-biology expertise, today announces the appointment of Dr. ... Dr. Zurlo is an oncologist with many years ... pharmaceutical and biotechnology industries. His last role was at ... Member of the Executive Board. Previously Dr. Zurlo held ...
(Date:4/28/2016)... 2016  Marking its one year anniversary since ... cancer risk test, Color Genomics announced ... highly impact the most common hereditary cancers affecting ... Test analyzes hereditary cancer risks for breast, colorectal, ... The Color Test is physician ordered and includes ...
(Date:4/28/2016)... , April 28, 2016 Dr. ... and Ste phen ... ArisGlobal®, a leading provider of cloud-based software solutions for life ... Pharmacovigilance team to bring a wealth of insight to a growing ... pharmacovigilance knowledge. George Phillips joined ArisGlobal in ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... , ... Our bodies are bombarded daily by environmental and lifestyle factors that ... is to adopt a more healthful diet, but too many people think that food ... Nutritionist and the creator of the Newport Beach Cleanse and 14-Day Eating Plan, disagrees ...
(Date:4/29/2016)... , ... April 29, 2016 , ... On Tuesday, April ... across the Southeast, celebrated the signature of Gov. Nathan Deal on SB 258, the ... Duncan (R - Cumming), offers a 70% tax credit to individuals and corporations which ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American workforce ... stability, even security. Most importantly, employees are the single most important asset in ... workers so unhappy? , Just under half of American workers are emotionally checked ...
(Date:4/29/2016)... ... April 29, 2016 , ... Dr. Bernie Siegel, ... "LOVE, MEDICINE and MIRACLES") addresses touchy topics related to Death live on ... Dr. Bernie Siegel, author of a plethora of essential books-to-read for physicians ...
(Date:4/29/2016)... ... April 29, 2016 , ... The White House ... their loans, more information about their loan terms and accounts, and more protections ... debt, including federal and private loans, has reached $1.3 trillion, with 43 million ...
Breaking Medicine News(10 mins):