DMI BioSciences, Inc. Reports Promising Results From Phase IIa Clinical Trial For Premature Ejaculation

ENGLEWOOD, Colo., March 1 /PRNewswire/ -- DMI BioSciences, Inc. (DMI) reports the successful outcome of a Phase IIa study with DMI's investigational drug (DMI-7958) in men suffering from premature ejaculation. The trial was conducted in Europe by an international contract research organization (CRO) using a placebo controlled, randomised, double blind crossover design. DMI-7958 successfully met the endpoint demonstrating substantial effect against placebo in male volunteers suspected of having primary physiological premature ejaculation. DMI-7958 was well tolerated with no serious adverse events reported. DMI-7958 is being co-developed with Enhance Biotech, Inc. to treat premature ejaculation on an "as needed" basis and further clinical trails are presently being designed.

An estimated 50 million men worldwide are affected by premature ejaculation, a condition four times more prevalent than erectile dysfunction. The potential annual market for the treatment of premature ejaculation may be in excess of $5 billion. Currently, there is no approved drug for the treatment of premature ejaculation.

Bruce Miller, President and CEO of DMI added: "These are good preliminary results from a well designed and successfully conducted clinical trial. DMI-7958 is the leading member of a family of products that we are investigating with Enhance Biotech for treatment of premature ejaculation, a condition that affects most men at some time in their lives. We look forward to the continuing success of this collaboration."

DMI BioSciences, Inc. is a privately-held biopharmaceutical company based in Englewood, Colorado, that discovers and develops small molecule and peptide-based pharmaceuticals and biomarkers for acute and chronic inflammation. DMI focuses on immunologic, vascular and CNS diseases, including acute coronary syndrome, multiple sclerosis, Alzheimer's disease, asthma and cancer. DMI is co-developing several of its drug candidates with industry partners. Two of DMI's drug candidates are currently in human clinical trials. DMI's strategy is to develop pharmaceutical compounds and biomarkers through preclinical and early-stage clinical development and collaborate with financial and industry partners for later-stage development and commercialization.

Except for the historical information presented herein, matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including but not limited to statements that are preceded by, followed by, or that include the words "will;" "believes;" "should;" "intends;" "anticipates;" "plans;" "expects;" "estimates;" or similar statements are forward-looking statements. Forward looking statements include statements about the potential benefits of the collaboration and license agreement between DMI Biosciences and Enhance Biotech and DMI-7958's use, either alone or in conjunction with compounds, as a treatment for premature ejaculation. Risks and uncertainties include risks regarding the discovery and product development process generally, risks associated with the introduction of competitive products from companies with greater capital and resources, expansion or development of a direct sales effort in domestic and international markets, and risks and expenses associated with litigation, contract disputes, patent conflicts, product recalls, manufacturing constraints, backlog, delays or inefficiencies, shipment problems, seasonal customer demand, the timing of significant orders, changes in reimbursement policies, regulatory changes, competitive pressures on average selling prices, risks associated with the identification of potential markers of disease and proteins with high diagnostic utility and the development and commercialization of new products out of these discoveries. DMI BioSciences disclaims any intent or obligation to update these forward-looking statements.

DMI BioSciences, Inc.

CONTACT: DMI BioSciences, Inc., +1-303-789-1929, fax +1-303-789-0510,info@dmibiosciences.com

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