AlphaRx Inc. (OTCBB: ALRX) reported positive preclinical results on GAI-122 injectable nano-emulsion in multiple models of acute hepatitis, an inflammatory liver disease.

GAI-122 significantly reduced Aminotransferase (ALT), an enzyme released into the blood that indicates damage to the liver, following IP administration in three different preclinical models of acute liver injury. Very high levels of ALT are usually due to acute hepatitis or a viral infection.

In the a-Fas model of liver injury, GAI-122 markedly reduced ALT levels by 90% from baseline, where control ALT values were ~22,000 IU/L. Significant efficacy was also demonstrated in the rat TNFa/Gln model and in the Drug-induced liver injury (DILI) model.

“DILI accounts for more than 50% of acute liver failure and there are no satisfactory treatment options currently available. The excellent efficacy data demonstrated by these studies suggest that GAI-122 may represent a potential first line treatment option for patients with liver disease”, stated Dr. Michael Weisspapir, MD, PhD, Chief Medical Scientist of AlphaRx.

In October 2008, AlphaRx 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.

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 nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development.

About Gaia BioPharma

Gaia BioPharma Limited, a privately held, early stage biopharmaceutical company focused on hospital-based injectable therapeutics. Gaia BioPharma seeks to address key unmet therapeutic needs by taking established compounds and changing their administration routes to create patent-protected, value-added products.

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 Company.

Source: AlphaRx Inc

WASHINGTON, July 10 — The FDA has approved the oral antiplatelet agent prasugrel (Effient), putting it in top running as a direct competitor for clopidogrel (Plavix).

Prasugrel is indicated for reduction of heart attack risk from thrombosis formation in patients who undergo angioplasty, but the drug will carry a boxed warning of the risk of significant, sometimes fatal, bleeding.

The approval came as no surprise in the cardiology community.

FDA staff had called prasugrel’s efficacy “beyond question,” and reviewers even recommended forgoing an advisory panel meeting. (See FDA Advisory Panel to Vote on Approval of Prasugrel)

After several delays, an FDA advisory committee in February unanimously voted for approval of prasugrel based primarily on findings from the TRITON-TIMI 38 trial. (See Panel Supports FDA Approval of Prasugrel)

That trial showed a 19% reduction in composite cardiovascular death, MI, and stroke compared with clopidogrel (9.9% versus 12.1%, P<0.001). (See AHA: Prasugrel Reduces Ischemic Events but Increases Bleeding in Acute Coronary Syndrome)

The number of patients who had a subsequent nonfatal MI dropped to 7.0% with prasugrel compared with 9.1% with clopidogrel.

Based on this result, Lilly — which manufactures prasugrel in partnership with Daiichi Sankyo — had requested a “superiority claim” that prasugrel prevents thrombosis better than clopidogrel.

However, the FDA’s approval excluded mention of superiority.

Instead, it emphasized safety, which has been a long-standing concern with prasugrel and the cause of delays in approval.

In the TRITON-TIMI 38 trial, major bleeding events occurred in 2.4% of prasugrel patients compared with 1.8% of those in the clopidogrel arm.

Since most of these events occurred in patients with a history of stroke or transient ischemic attacks and in elderly, frail patients — those older than 75 and weighing less than 60 kg — the FDA cautioned that prasugrel should not be used in patients with a history of transient ischemic attacks or stroke.

Other contraindications included active pathological bleeding and urgent need for surgery, including coronary artery bypass graft surgery, according to the agency.

“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” said John Jenkins, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

Aaron Kugelmass, MD, of Baystate Medical Center in Springfield, Mass., agreed that consideration of bleeding risk prior to prescribing prasugrel will be important with the new agent, but called it an important advance for patients receiving stents.

Another leading cardiologist, John S. Douglas Jr., MD, of Emory University in Atlanta, noted that while the drug will have an important role in practice, prasugrel will have “its most appropriate application in patients with a higher risk of these complications (such as diabetics) and a low risk of bleeding.”

Drs. Jenkins, Kugelmass, and Douglas provided no information on conflicts of interest.

This article was developed in collaboration with ABC News.

Related Article(s):

• FDA Advisory Panel to Vote on Approval of Prasugrel
• Panel Supports FDA Approval of Prasugrel
• AHA: Prasugrel Reduces Ischemic Events but Increases Bleeding in Acute Coronary Syndrome

LITTLE FALLS, N.J., July 10 — The maker of an insulin infusion device used with an insulin pump has initiated a voluntary recall of the devices due to a mechanical malfunction that could result in serious injury or death.

Medtronic is asking consumers to cease use of its Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps. The company said the recall involves about 60,000 of the infusion sets out of an estimated three million currently in use.

In a press release, the company said the malfunction could prevent air from venting properly, which would cause the device to deliver too much or too little insulin.

Devices covered by the recall are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Lot numbers are identifiable on the box label and on individual infusion packaging.

Chris O’Connell, president of the Diabetes business unit and a senior vice president at Medtronic, said the company was working closely with the FDA “to make this product exchange as timely and as easy as possible for patients.”