MediciNova Announces Results From a Phase II/III Interstitial Cystitis Trial With MN-001
SAN DIEGO, Jan 16, 2007 (PrimeNewswire via COMTEX News Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on NASDAQ (Trading Symbol: MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced the results from its Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-001 in 305 patients with moderate-to-severe interstitial cystitis (IC). While MN-001 was well-tolerated, MN-001 did not show a statistically significant clinical benefit compared to placebo on the primary endpoint (to be much or very much improved overall on a patient-rated Global Response Assessment) at the doses tested in this trial (500mg once or twice a day for 8 weeks).
Results from this Phase II/III trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day compared to placebo (25% compared to 12%, p=0.04) after 4 weeks of treatment. This difference, however, was not observed at 8 weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500 mg of MN-001 once a day did not significantly differ from placebo at either 4 or 8 weeks.
"Although we are disappointed that MN-001 did not demonstrate a statistically significant improvement in IC symptoms, we believe that the compound warrants continued development, especially in bronchial asthma where positive clinical trial results have been observed at higher doses," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "In our Phase II asthma trial, a statistically significant improvement in mean FEV1 (forced expiratory volume in 1 second) was observed after 4 weeks of treatment with 500 mg MN-001 three times a day compared to placebo (p=0.021; intent-to-treat, observed cases). A similar trend was observed for the 750 mg twice a day dose (p=0.058). We plan further analysis of the data from our clinical trial in IC with the goal of reevaluating our clinical strategy and determining the future of this program. We also anticipate important milestones throughout the year in our other clinical programs which are progressing well."
MN-001 is a novel, orally bioavailable compound that has been shown to block a number of the inflammatory mechanisms activated by mast cell degranulation that are important in the pathogenesis of inflammatory disorders including IC and asthma (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2). MN-001 produces anti-inflammatory effects in a variety of rodent models of IC and asthma; in these models, MN-001 reduces bladder hyper-reactivity much in the same way that it reduces airway hyper-reactivity in the lung.
MediciNova acquired a license to MN-001 from Kyorin Pharmaceutical Co. Ltd. for global markets excluding Japan, China, Taiwan and South Korea. The intellectual property acquired from Kyorin included extensive preclinical and clinical safety data.
About Interstitial Cystitis
Interstitial cystitis (IC) is a chronic sterile disease of the bladder characterized by urinary frequency, urgency, nocturia (night-time urination) and pelvic and bladder pain. Symptoms vary between patients, and may vary between episodes in the same patient. The average patient has symptoms for five years and sees five different clinicians before a diagnosis of IC is made. In the U.S., more than 800,000 patients suffer from IC. IC represents a serious women's health concern, as women are nine times more likely to develop the disease than men. Due to the difficulty in diagnosing IC, recent surveys suggest that these numbers may significantly under-represent the actual disease population.
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. 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. For more information on MediciNova, Inc., please visit www.medicinova.com.
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This press release may contain "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical trials supporting efficacy of one of our product candidates as well as the potential novelty of that candidate as a treatment for disease. These statements are based on certain assumptions made by the Company's management that are believed to be reasonable at the time. Such statements are subject to a number of risks and uncertainties, many of which are beyond the control of the Company, including the results of clinical studies and other risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. These assumptions, risks and uncertainties could cause the Company's actual results to differ materially from those implied or expressed by the forward-looking statements.
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SOURCE: MediciNova, Inc.
MediciNova, Inc. Kenneth W. Locke, Ph.D., Chief Business Officer (858) 373-1200 firstname.lastname@example.org
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Posted: January 2007
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