Sypharma Pty, Ltd., a privately owned Australian company based in Melbourne, announced today that it will be supplying an aseptically manufactured biological for Clinical Trials in Europe.   The deal with Daval International Ltd, a UK based Biotech Company, has come about after regulatory approval was granted to provide Investigational Medicinal Product and Placebo for European trialing of new biological, AIMSPRO®.  This follows the listing of AIMSPRO, an injectable hyperimmune caprine serum derivative, on the Export section of the Australian Register of Therapeutic Goods.  The two clinical trials address late stage Scleroderma (Diffuse Sclerosis) and Bladder Dysfunction in Secondary Progressive Multiple Sclerosis.  Sypharma has also provided product for three Veterinary trials of this novel anti-inflammatory agent.

AIMSPRO

AIMSPRO is composed of a set of peptides where laboratory testing has shown to act in stimulating the release and regulation of a molecular cascade that modulates the Hypothalamo-Pituitary-Adrenal (HPA) axis and induces a predominantly TH-2 anti-inflammatory profile.  The complex manufacturing process includes low ambient temperature specifications and the finished medication is vialled and then frozen, to be thawed immediately prior to injection.  AIMSPRO has a favourable safety and tolerance profile, 20,000 doses having been administered, sub-cutaneously, over the last 6 years, in open-label and pilot settings.

AIMSPRO has achieved Orphan Drug designation in Australia for the treatment of Krabbe Leukodystrophy.  The FDA Investigational New Drug (IND) application process is now being undertaken following the interest of key researchers from two US Universities in the conduct of further Randomised Clinical Trials.

Sypharma has also signed an exclusive contract with Daval to develop the Veterinary form, Ceremben®, in the Australasian market and is sponsoring a trial, in conjunction with the University of Melbourne, for the treatment of endotoxaemia in Horses.

SYPHARMA

Sypharma recently spent 12 months upgrading their plant, building new aseptic biopharmaceutical formulation facilities.  CEO Jeremy White says, "We are aggressively seeking new business and partnering opportunities, and because we have spare capacity in our production facility available right now, we can move into production immediately.  Up until now there have been few small scale facilities with aseptic manufacturing capabilities available in Australia.

"There is a huge demand for small scale clinical development facilities, and our organization can move quickly to provide substantial savings in development timelines.  

"We have found a great level of interest from international clients for their outsourcing requirements, as we provide key skill-sets, competitive costings and the ability to meet International regulatory requirements."

ABOUT SYPHARMA

Sypharma is located in Melbourne, the centre for Biotechnology in the Asia Pacific, where there exists a unique partnering with other research and testing organizations and World-ranking Universities.

Sypharma provides biopharmaceutical manufacturing, aseptic filling of small volume parenterals (Fill and Finish), terminal sterilization of large volume parenterals and a new "state-of-the-art" veterinary manufacturing facility offering powder, liquid and cream manufacturing capabilities.