ANN ARBOR, MI--(Marketwire - September 18, 2012) - Phrixus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on innovative therapies for Duchenne muscular dystrophy (DMD) and heart failure, announced today that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for U.S. Patent Application Serial Number 12/593,798, titled "Compositions and methods for the treatment of heart failure." The application includes claims intended to protect Phrixus's investigational drug Carmeseal™ (poloxamer-188) for the treatment of heart failure in a number of diseases with concomitant heart failure. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2029. Such exclusivity would be separate from and in addition to exclusivity provided under the Orphan Drug Act and the Hatch/Waxman Act through the Food and Drug Administration for the treatment of DMD and other indications.
Information on Phrixus's patents and pending applications in the United States is available on the Patent Application Information Retrieval system maintained by the USPTO at http://portal.uspto.gov/external/portal/pair. Phrixus has filed similar applications with the European Patent Office (EPO) and the Patent Cooperation Treaty (PCT).
The claims of the '798 patent application cover the use of poloxamers and poloxamines including poloxamer-188 for the treatment of heart failure by lowering left ventricular end-diastolic pressure or increasing left ventricular ejection fraction. The '798 patent application is part of Phrixus's IP estate, licensed in part exclusively from the University of Michigan, including PCT/2006/006862, PCT/US2007/017182, PCT/US2008/004437, and PCT/US2008/087185, all of which cover various aspects of the use of poloxamers and poloxamines as human therapeutics.
"This patent, once granted, will be an important addition to our growing patent portfolio and strengthens our ability to exclusively provide P-188 for important unmet medical needs such as different dystrophies and acute decompensated heart failure," said Thomas A. Collet, president and CEO. "The Patent Office's Notice of allowance is based on the surprising and unexpected finding that poloxamer-188 has a beneficial effect in heart failure at doses orders of magnitude lower than previously employed by others, such as Burroughs Wellcome and CytRx, in unrelated indications," adds Dr. Bruce Markham, Vice President of Research and Chief Scientific Officer.
DMD is the most devastating of the muscular dystrophies. No drug is approved for its treatment. It is a genetic disease that affects about 20,000 boys and young men in the United States. The hallmarks of DMD are skeletal muscle weakness, respiratory distress, and cardiomyopathy. It is a degenerative disease that leads to premature death.
Heart failure occurs when the heart is unable to pump enough blood around the body. It affects five million Americans and costs the health care system $37 billion annually according to the American Heart Association. Acute Decompensated Heart Failure (ADHF) is the most severe form of heart failure. It causes about one million hospitalizations each year.
Carmeseal, generically known as poloxamer-188 (P-188), has been shown pre-clinically to improve the efficiency of damaged hearts to pump blood and to improve the performance of damaged diaphragms with once-a-day subcutaneous administration at very low doses. When Carmeseal, which acts as a molecular band-aid, is infused into the bloodstream, it encounters and binds to microscopic tears in the muscle. This prevents the pathological leak of calcium into the cells, which causes calcium overload and keeps the muscle from performing as required. Carmeseal, which has been shown to be effective in several animal models of DMD, heart failure and dysferlinopathy, is expected to have its effect in patients with DMD irrespective of the genetic defect that causes the disease.
About Phrixus Pharmaceuticals, Inc.
Phrixus Pharmaceuticals is developing Carmeseal for DMD and for acute decompensated heart failure. For more information about Phrixus Pharmaceuticals, please visit www.phrixuspharmaceuticals.com.
Phrixus Pharmaceuticals, Inc. Forward-Looking Statement Disclaimer
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.