AlphaRx and Gaia BioPharma Report Positive

29.06.2009 14:08
AlphaRx and Gaia BioPharma Report Positive Efficacy Results in a Pre-Clinical Trial of GAI-122 Injectable Nano-emulsion for Post-operative Delirium / GAI-122, an investigational injectable nanoemulsion formulated with AlphaRx's proprietary drug delivery t

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AlphaRx, a specialty pharmaceutical company, and Gaia BioPharma, a biopharmaceutical company, have reported positive preclinical results on GAI-122 injectable nanoemulsion in multiple in vitro and in vivo studies of memory impairment after prolonged anesthesia.

In rat model studies, injected GAI-122 ameliorates learning and memory disturbances produced by cerebral embolization, cerebral ischemia or lesions in the basal forebrain, the area of origin of the acetylcholine neuron system projecting into the cerebral cortex, hippocampus and amygdala.

In clinical tests, an oral form of GAI-122 has been shown to be effective in psychological deficits such as a decline in memory retention and disorientation.

AlphaRx has previously licensed GAI-122 to Gaia BioPharma. Under the terms of the amended agreement, AlphaRx is eligible to receive milestone payments of up to $50 million for the successful development and commercialization of GAI-122, as well as royalties on worldwide sales. In addition, Gaia BioPharma has assumed all development costs.

Michael Weisspapir, chief medical scientist of AlphaRx, said: "There are over 10 million inpatient surgeries performed annually in the US on patients over the age of 65, and up to 40% of these seniors will develop post-operative delirium. There is an urgent need to develop a medicine, such as GAI-122 injectable nanoemulsion, for the preventive of this debilitating post-operative condition."

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MARKHAM, ON, Aug. 4 /PRNewswire-FirstCall/ -- AlphaRx Inc. (OTC BB:ALRX.OB - News), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, today announced that the Company has entered into a collaboration agreement with Venturepharm Group (the "Venturepharm") to establish a drug development center in China Medical City, Taizhou, China that is expected to be used as a platform for the development of innovative drug products for the fast growing China pharmaceutical market. The goal of this is to enhance the Company's research capabilities, expedite the development of new products as well as to expand the Company's product range.

Under the terms of the agreement, AlphaRx will incorporate its China R D facility into Venturepharm's state of the art pre-clinical development complex which comprises of a 200,000 sq. ft. chemistry center, a 200,000 sq. ft. multi-product pilot plant to support pilot scale formulation and Clinical Trial Material (CTM) manufacture of biopharmaceutical products and a 500,000 sq. ft. (Asia's largest) animal testing center (under construction). The in-house pharmaceutical research facilities provide specialized equipment for most aspects of drug research and development. AlphaRx will be responsible for all of its own product development costs and will in turn retain the intellectual property rights relating to any developed products.
Michael Lee, President of AlphaRx, said: "Venturepharm provides the equipment and physical infrastructure to further establish our presence in China and reduces our start up investment costs. As AlphaRx continues to build its presence in China, this collaboration with Venturepharm marks an important step in our overall strategy to commercialize current products and to develop new therapeutics for the world fastest growing pharmaceutical market."

About AlphaRx Inc.

AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary site-specific drug delivery technology, offers improved medical benefits and a potential for significant commercial product development.

About Venturepharm group

Venturepharm Group is an Asia based life science leader that provides world-class, innovative, affordable and integrated service in CRO, CMO and CSO, as well as venture capital, merchant banking for the biotechnological and pharmaceutical industry. Venturepharm also engages in compound licensing, compound partnering and royalty sharing with its clients to expand the market of their products. Venturepharm conducts its business in China as well as global top five markets. The group now operates eight distinct business units with over 2500 employees worldwide.

Forward Looking Statements:

This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the companies.

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Markham, ON, Aug. 17 / Update wird - AlphaRx Inc. (OTC BB:ALRX.OB - News), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that it has completed the lyophilization process for Zysolin(TM), allowing the company to proceed to clinical batch material manufacturing for human trials. (OTC BB: ALRX.OB - News), ein biopharmazeutisches Unternehmen, aufstrebenden proprietäre Verwendung von Drug-Delivery-Technologien zur Entwicklung neuer Formulierungen von Drogen, freut sich bekannt zu geben, dass sie die Lyophilisierung für Zysolin (TM), so dass die Unternehmen, um Batch-Herstellung von klinischen Material für den menschlichen Studien. This process has been solely developed by AlphaRx's scientists and the resulting formulations have been successfully tested in animal studies conducted by the US Army under a Material Transfer Agreement. Dieser Prozess wurde ausschließlich von AlphaRx die Wissenschaftler und die sich daraus ergebenden Formulierungen wurden erfolgreich getestet in tierexperimentellen Studien, die von der US-Armee unter einem Material Transfer Agreement.

"This is a technological milestone for AlphaRx and the entire nanomedicine industry," commented Dr. Joseph Schwarz, AlphaRx's Chief Scientist. "Dies ist ein technologischer Meilenstein für AlphaRx Nanomedizin und die gesamte Industrie", kommentiert Dr. Joseph Schwarz, AlphaRx's Chief Scientist. "It is well known that many FDA approved ingredients used in nanomedicine formulations can not be readily lyophilized, representing the major obstacle to their therapeutic development, a critical step which we have overcome." "Es ist bekannt, dass viele FDA zugelassenen Zutaten auf dem Gebiet der Nanomedizin Formulierungen können nicht ohne weiteres lyophilisierte, die das größte Hindernis für die therapeutische Entwicklung, ein entscheidender Schritt, die wir überwunden haben."

Many biotechnology products require lyophilization, a process of freeze-drying sterile solutions to permit a shelf stable dosage form. Viele Biotech-Produkte erfordern Lyophilisierung, einen Prozess der Gefriertrocknung sterilen Lösungen, um ein Regal stabil Darreichungsform. By removing the water from the material and sealing the material in a vial, it can be easily stored, shipped, and later reconstituted to its original form for administration. Durch das Entfernen des Wassers aus dem Material-und Verschließmaschine das Material in einer Durchstechflasche, es können leicht gespeichert, verschickt und später wieder zu seiner ursprünglichen Form für die Verwaltung.

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AlphaRx Concludes GAI-122 Formulation Development Intended For The Prevention of Delirium

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Global Investment Conference
MARKHAM, ON, Sept. 3 /PRNewswire-FirstCall/ -- AlphaRx Inc. (OTC BB: ALRX), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, today announced that it is scheduled to make an investor presentation at the Rodman Renshaw Annual Global Investment Conference at 2:25 pm EDT on Friday, September 11, 2009. The conference will be held at the New York Palace Hotel, September 9-11, 2009.

http://www.finanznachrichten.de/...obal-investment-conference-008.htm

MARKHAM, ON, Sept. 14 /PRNewswire-FirstCall/ -- AlphaRx Inc. (OTC BB: ALRX). Speaking at the 11th Annual Rodman Renshaw Healthcare Conference in New York City, AlphaRx Director Dr. David Milroy presented a company overview focusing on the Company's product pipeline, nano drug delivery platform and the significant developments anticipated within the next 12 months. In Summary, AlphaRx will have 3-4 products in different stages of clinical development by the end of 2010, which have major market indications and opportunities, producing a portfolio of short to long term drug candidates to position the company for stable and sustainable growth. In addition, AlphaRx presented 2 new product candidates ARX1088 and ARX2038 which are being developed for herpes and lipid management respectively. These products have excellent safety profile and have over 25 years of successful clinical applications outside the US. AlphaRx is developing a new dosage form for ARX1088 and ARX2038 and planning to initiate Phase II clinical trails in the later part of 2010.

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Riso Pharma

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