"We believe that MN-001 may offer a more rapid and effective treatment for IC than other agents currently in use today, and represents a significant market opportunity for MediciNova," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "Interstitial cystitis is an often under-diagnosed and under-recognized inflammatory condition that affects the health and quality of life of close to one million people in the U.S. today. MN-001 represents a valuable commercial asset for MediciNova, due to its unique anti-inflammatory mechanism of action and therapeutic potential as a treatment for asthma as well as IC. We look forward to advancing MN-001 to the next stage of clinical development in the near-term."
The pivotal-design Phase II/III clinical trial of MN-001 is a randomized, double-blind, placebo-controlled multi-center study in 305 patients with moderate-to-severe IC. The trial is being conducted at 34 clinical sites in the U.S. The primary endpoint of the study is the percentage of patients at least "moderately improved" for each treatment group in a patient-reported Global Response Assessment. MediciNova anticipates having results from this trial by the end of 2006.
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.
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.
MN-001 is also under development by MediciNova for the treatment of bronchial asthma. Positive results from a Phase II proof-of-concept study in asthma were reported in December 2005 and MediciNova expects to initiate its Phase III clinical program in asthma with MN-001 by the end of 2006.
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 MediciNova
MediciNova, Inc. is a publicly traded pharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. MediciNova's pipeline, which includes several compounds in clinical testing, targets a variety of prevalent medical conditions, including cancer, asthma, Generalized Anxiety Disorder, multiple sclerosis, interstitial cystitis, status asthmaticus, preterm labor and urinary incontinence. For more information on MediciNova, Inc., please visit www.medicinova.com.
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.
Source: MediciNova, Inc.
