First patient to be treated with Carmeseal-MD (P-188 NF) outside of the United States through Phrixus’s Expanded Access Program with Ethicor Pharma Ltd. –
ANN ARBOR, MI – X September 2017 – Phrixus Pharmaceuticals, Inc. (“Phrixus”), a company focused on therapies for Duchenne muscular dystrophy and heart failure, today announced that the Oirst patient with DMD completed 15-month of treatment with Carmeseal-MD. Treatment was well-tolerated; beneOits in these patients included reductions in muscle damage markers such as creatine kinase and cardiac troponin.
“The strong preclinical data, combined with human safety data from over 2,500 patients in un-related indications creates a strong rationale for using P-188 NF, a membrane stabilizer, in DMD, a disease that is characterized by membrane tears due to the absence of functional dystrophin,” said Bruce Markham, Ph.D., Chief ScientiOic OfOicer and VP Research of Phrixus. “Providing Carmeseal-MD as an unlicensed special provides an opportunity for specialty physicians outside of the United States to treat patients especially with regard to heart failure and respiratory dysfunction, the two leading causes of death,” added Thomas A. Collet, President & CEO. Carmeseal-MD is available outside of the United States through Phrixus’s Expanded Access Program and Ethicor Pharma Ltd., a distributor. For more information, please visit www.ethicorpharma.com or contact [email protected].
In animal models of DMD, Carmeseal-MD (Poloxamer 188 NF) has been shown to improve the efOiciency of damaged hearts and the performance of damaged diaphragms with once-a-day subcutaneous administration at low doses. When infused into the bloodstream, it encounters and binds to microscopic tears in the muscle and prevents the pathological leakage of calcium into the cells, which keeps the muscle from performing as required. Carmeseal-MD is expected to have its effect in patients with DMD irrespective of the genetic defect that causes the disease.
About Duchenne muscular dystrophy (DMD)
DMD is the most devastating of the muscular dystrophies. It is a genetic disease that affects about 20,000 boys and young men in the United States and a comparable number in Europe. The hallmarks of DMD are skeletal muscle weakness followed by respiratory distress and heart failure. As a degenerative disease, it inevitably leads to premature death, mostly through heart failure and respiratory failure.
About Ethicor Pharma Ltd.
Ethicor Pharma Ltd is a specialty pharmaceutical company committed to the distribution of unlicensed medicinal products (“specials”) on request from healthcare professionals to meet the clinical needs of individual patients when authorized medicines are not appropriate treatment option. ‘Specials’ are unlicensed medicines that are produced in limited quantities and are primarily used for the unmet clinical needs of an individual doctor’s patients, particularly where authorized medicines are not available. Ethicor is active in markets worldwide excluding the US and has a portfolio of generic and IP protected products. Please email [email protected] or visit www.ethicorpharma.com for more information on Ethicor.
About Phrixus Pharmaceuticals, Inc.
Phrixus Pharmaceuticals, Inc. is developing Carmeseal as Carmeseal-MD™ (P-188 NF for subcutaneous injection) for DMD and as Carmeseal-HF™ (P-188 NF for intravenous administration) for acute decompensated heart failure. Phrixus has assembled the leading global patent portfolio for the use of poloxamers in DMD, heart failure and respiratory dysfunction. For more information: Thomas A. Collet, [email protected] or www.phrixuspharmaceuticals.com.
Forward-Looking Statement Disclaimer This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reOlect management’s current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated. 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.