Cordex Signs European Development Partnership for ATPotent(TM) Sperm Motility Drug Press Release Source: Cordex Pharma, Inc. On Monday June 22, 2009, 8:15 am EDT Technology Intended to Improve Outcome of Intrauterine Insemination and In Vitro Fertilization Procedures
LA JOLLA, Calif., June 22 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP - News) announced today that it has entered into an agreement with Clinical Trials International, LLC, (CTI), regarding a license to develop and market Cordex's drug candidate, ATPotent(TM).
ATPotent(TM) is a novel ATP-based drug candidate designed for in vitro (outside of the human body) treatment of sperm in conjunction with intrauterine insemination (IUI) and in vitro fertilization (IVF) procedures. ATPotent(TM) is based on Cordex's proprietary technologies related to the use of adenosine 5'-triphosphate (ATP) for improving human and animal sperm motility and fertilization capacity.
According to the agreement, CTI has obtained exclusive rights for the clinical development and marketing of ATPotent(TM) in the European Union (EU) as well as Russia and Ukraine. CTI intends to initiate with Cordex's scientific support a proof-of-concept clinical trial in Italy later this year, the end-point of which is expected to be increased pregnancy rate in IUI procedures prescribed for couples with male infertility due to asthenozoospermia (i.e., low or lack of sperm motility). Cordex will have access to the clinical data to be obtained in this study to support the development of ATPotent(TM) in the rest of the world.
Male factor infertility is implicated in about half of the six million infertile couples in the United States. Lack of, or low sperm motility or movement, is a common cause of human male infertility. It has been reported in the medical literature that the prevalence of asthenozoospermia in infertile men is approximately 82 percent. Currently, there is no FDA-approved drug that enhances sperm motility.
Cordex has sponsored studies at the University of Pennsylvania and the University of Padua, which have shown that in vitro ATP treatment of poorly motile human sperm resulted in improved motility parameters and increased frequency of hyperactivated sperm. The improved motility parameters were also observed in human sperm derived from males with asthenozoospermia and in thawed cryopreserved human sperm.
Results from these published studies support earlier observations from a non-Cordex sponsored European study in which increased success rate of IVF procedures were observed when ATP-treated sperm derived from infertile males with asthenozoospermia were used.
"We are pleased to enter this agreement with CTI as we feel it will accelerate the development of ATPotent(TM) as a novel treatment for the majority of male infertility cases in the United States and other parts of the world," said James S. Kuo, M.D., M.B.A., Cordex's Chairman and CEO. "CTI has the experience, expertise, and track record of obtaining EU regulatory approval for medical products originally developed in the US and marketing them there," he added. "Data obtained by CTI in its clinical trial are expected to support Cordex's efforts to seek marketing approval for ATPotent(TM) from the FDA," said Amir Pelleg, Ph.D., Cordex's President and CSO.
About ATPotent(TM)
ATPotent(TM) is Cordex's novel and proprietary drug candidate for the in vitro treatment of human and animal sperm, in which the active ingredient is adenosine 5'-triphosphate (ATP). ATP is a ubiquitous purine nucleotide found in every cell of the human body where it plays a critical role in cellular metabolism and constitutes the source of energy for all bodily functions. ATP is released from cells under physiologic and pathophysiologic conditions; extracellular ATP acts as a local physiologic regulator by activating cell surface receptors called P2 receptors. Extracellular ATP plays an important role in sperm maturation in the male reproductive tract and is a mandatory co-factor of fertilization in the female reproductive tract. Cordex's sponsored studies have shown that ATP treatment can improve the motility and fertilization capacity of malfunctioning sperm obtained from infertile males due to asthenozoospermia as well as thawed sperm that had been cryopreserved.
About Cordex Pharma, Inc.
Cordex is a specialty pharmaceutical company that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These two molecules play critical roles in cellular metabolism and signal transduction, the manipulation of which constitute novel therapeutic modalities for the treatment of major cardiovascular disorders. Cordex has a portfolio of investigational medicines, two of which are in late stages of clinical development. ATPace(TM) is expected to enter a Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia. Cordex's CDP-1050 is expected to commence a Phase 2 clinical trial for the treatment of heart failure. In addition, Cordex has a preclinical program to develop new chemical entities that target a recently discovered pathway in the pathophysiology of chronic obstructive pulmonary diseases. For further information regarding Cordex, please visit the company's website at www.cordexpharma.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. The forward-looking statements are based on current expectations, estimates and projections made by management. Cordex intends for the forward-looking statements to be covered by the safe harbor provisions for forward-looking statements. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," or variations of such words are intended to identify such forward-looking statements. All statements in this release regarding the future outlook related to Cordex are forward-looking statements, including, but not limited to, the statements regarding the timing and expected results of the ATPotent(TM) proof-of-concept clinical trial in Italy, the statements regarding the timing of ATPace(TM)'s expected entry into a pivotal Phase 2b/3 clinical trial for the treatment of paroxysmal supraventricular tachycardia, the timing of CDP-1050's expected commencement of a Phase 2 clinical trial for the treatment of heart failure, the expected results of the use of ATPace(TM) and the estimated PSVT market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Such risks include the risk that the data derived from the trials may not be sufficient to support marketing of approval of the products, clinical trial for approval of ATPace(TM) and the Phase 2 clinical trial for our CDP-1050 may not be successful, the results of the clinical trial for ATPotent(TM) may not be as expected, that our preclinical program to develop new chemical entities that target a newly discovered pathway in the pathophysiology of chronic obstructive pulmonary disease may not be successful, the market may not be as anticipated and that our technology may not lead to expected results including the development or the successful commercialization of technologies relating to the use of ATP or nitric oxide. Additional uncertainties and risks are described in Cordex's most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-KSB. Copies of these filings are available through the SEC website at http://www.sec.gov. All forward-looking statements are based upon information available to Cordex on the date hereof. Cordex undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law.
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