SAN DIEGO, Sept. 27, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today announced that it presented positive findings from a Phase I clinical study of MN-029, its novel vascular disrupting agent (VDA), at the 14th European Cancer Conference (ECCO 14) in Barcelona, Spain.
This open label, dose-escalating clinical study enrolled 34 patients at two centers in the U.S. MN-029 was administered as an intravenous infusion once every three weeks with a 20-day recovery period between doses (1 cycle) to patients with advanced solid tumors for whom no standard therapy was available.
The study results showed a statistically significant correlation (p=0.001) between increasing exposure to MN-029 (plasma AUC0-24h) and Ktrans, a dynamic contrast-enhanced MRI imaging (DCE-MRI) marker of tumor blood flow and vascular permeability. Tumor blood flow reduction, as assessed by DCE-MRI, was recorded at doses of 120, 180 and 225 mg/m2 of MN-029, but not at 80 mg/m2. Nine of 34 patients with advanced solid tumors for whom no standard therapy was available had stable disease after three cycles of treatment. Six patients (primary tumor -- carcinoid (3), melanoma (2) and pancreatic (1)) had prolonged (more than or equal to 6 months) stable disease. To date, three of these patients remain on therapy with MN-029 and continue to have stable disease (one with melanoma for 23 months, two with carcinoid for 21 months and 32 months). Although no patients showed objective responses based on RECIST criteria (tumor length on CT or MRI scan), semi-automated measurements of tumor volumes from CT scans showed a measureable reduction in tumor burden in the subject with the largest reduction in tumor blood flow (Ktrans -40%). A maximum tolerated dose of 180 mg/m2 was established in this study; the most common side effects of MN-029 were characteristic of other VDAs and included nausea, vomiting, fatigue and diarrhea.
"The results of this clinical study further support the concept and potential benefits of using a novel VDA like MN-029 to treat solid tumor cancers," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "We are working diligently to monetize this valuable and promising asset through our corporate development efforts."
About MN-029
MN-029 is a novel small molecule Vascular Disrupting Agent under development by MediciNova for treatment of solid tumor cancers. MN-029 selectively disrupts newly-formed tumor blood vessels, shutting down tumor blood flow and causing central necrosis of solid tumors. A variety of rodent models, including nude mice and rats bearing human tumor xenografts, have been used to demonstrate the antitumor activity of MN-029, both as monotherapy and in combination with chemotherapy or radiation. Consistent with its proposed mechanism of action, MN-029 has been shown to reduce tumor blood flow resulting in tumor cell necrosis in rats bearing a human lung tumor xenograft and in mice bearing a human breast cancer tumor xenograft. The present Phase I study now extends these findings (reductions in tumor blood flow) to cancer patients.
MediciNova acquired a worldwide license to MN-029 from Angiogene Pharmaceuticals Ltd. of the United Kingdom.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. MediciNova's strategy is to commercialize selected product candidates in the United States and to monetize other programs at key value inflection points. For more information on MediciNova, Inc., please visit www.medicinova.com.
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Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development and commercialization, strategies and future performance. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, MediciNova's reliance on third parties and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, the failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2006 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.