LA JOLLA, California, October 22, 2020 (GLOBE NEWSWIRE) – MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ: MNOV) and the Tokyo Stock Exchange JASDAQ Market (code number : 4875), announced today that it plans to initiate a randomized, multicenter, placebo-controlled Phase 2b trial to evaluate MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy (CIPN).
The clinical trial is a collaborative effort between MediciNova, the University of Sydney, and the Australasian Gastro-Intestinal Trials Group (AGITG). Dr Janette Vardy, Professor of Cancer Medicine, University of Sydney in Australia, will be the principal investigator. The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment to reduce the severity of acute neurotoxicity and CIPN in patients with metastatic colorectal cancer. AGITG will provide funding for this study and MediciNova will provide the study drug and regulatory support.
Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. commented, “We are excited to collaborate with Dr. Vardy on this grant-funded study to further explore the potential of MN-166 as a pharmacotherapy for CIPN. . As we recently reported, our first clinical trial at CIPN showed that half of the participants reported an improvement in symptoms in the acute period and showed better neurological parameters on clinical evaluation with ibudilast treatment. There is a great unmet medical need for patients with this disorder. ”
Dr. Janette Vardy, principal investigator of this study, commented: “The findings of our initial study were encouraging and, with the support of AGITG and MediciNova, we plan to further explore the possible clinical utility of ibudilast in a larger sample of patients. experiencing
About the Chemotherapy-induced peripheral neuropathy [19459459006] Trial]
multicenter, randomized, double-blind, placebo-controlled phase 2b to determine whether MN-166 (ibudilast) can decrease symptoms of acute neurotoxicity and CINP, and to determine whether ibudilast treatment produces fewer neurotoxicity-induced dose reductions in patients with metastatic colorectal cancer receiving oxaliplatin for up to six months. We plan to enroll a total of 100 patients in a 1: 1 ratio (ibudilast: placebo). Treatment (MN-166 (ibudilast) 60 mg / day or equivalent placebo) will begin two days before the first cycle of oxaliplatin chemotherapy and will continue for the duration of oxaliplatin chemotherapy.
Approximately Chemotherapy-induced peripheral neuropathy
Peripheral neuropathy is a set of symptoms caused by damage to the nerves outside the brain and spinal cord. These distant nerves are called peripheral nerves. Some of the chemotherapies and other drugs used to treat cancer can damage the peripheral nerves that transmit sensations to the hands and feet. This damage results in chemotherapy-induced peripheral neuropathy (CIPN) and is a common side effect of cancer chemotherapy. Most often, people complain of "tingling" in the fingers and toes. CIPN can affect cancer outcomes due to chemotherapy dose reductions and / or premature discontinuation of treatment and has a profound impact on quality of life and survival. According to a meta-analysis that included more than 4000 patients, the prevalence of CIPN was 68% when measured in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more (Seretny et al., 2014). Long-term neurotoxicity is an important issue for the growing number of cancer survivors, and the largest number of affected patients have received treatment for breast or colon cancer.
About MN-166 (ibudilast)
MN-166 (ibudilast) is an orally bioavailable, small molecule macrophage migration inhibitor of first class inhibitor factor (MIF) and phosphodiesterase inhibitor (PDE) -4 and -10 that suppress pro-inflammatory cytokines and promote neurotrophic factors. Our first human studies demonstrated significant reductions in serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play an important role in certain neurological conditions. The anti-neuroinflammatory and neuroprotective actions of MN-166 (ibudilast) have been demonstrated in preclinical and clinical studies, which provide the rationale for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases. like glioblastoma. (GBM) and substance abuse / addiction. MediciNova is developing MN-166 for ALS, progressive MS, and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse / addiction, and chemotherapy-induced peripheral neuropathy, as well as prevention of the syndrome of acute respiratory distress (ARDS) caused by COVID-19. MediciNova has a portfolio of patents covering the use of MN-166 (ibudilast) to treat various diseases, including ALS, progressive MS, and drug addiction.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company founded on the development of novel small molecule therapies for the treatment of illnesses in need with a primary business focus on the US market. MediciNova's current strategy is to focus on BC-PIV SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (eg, Alcohol use disorder, methamphetamine dependence, opioid dependence), and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19 and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). The MediciNova pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin). For more information about MediciNova, Inc., visit www.medicinova.com.
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 the future development and efficacy of BC-PIV SARS-COV-2 vaccine MN-166, MN-001, MN-221 and MN-029. These forward-looking statements may be preceded, followed by or include the words "believes", "expects", "anticipates", "intends", "estimates", "projects", "may", "could" "may," "will "," would, "" considering "," planning "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 in such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied in these forward-looking statements include, but are not limited to, the risks of obtaining future partners or grants for the development of BC-PIV SARS-COV-2 Vaccine MN-166, MN-001, MN-221 and MN-029 and risks of raising sufficient capital when necessary to fund MediciNova operations and its contribution to clinical development , risks, and uncertainties inherent in clinical trials, including the potential cost, expected timing, and risks associated with clinical trials designed to meet FDA guidelines and the feasibility of further development considering these factors, product development and marketing risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk sgo from delays or failure to obtain or maintain regulatory approval, risks associated with reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in candidate products, and the ability to defend and enforce such intellectual property rights, the risk of non-compliance by third parties that MediciNova relies on to conduct its clinical trials and manufacture its candidate products to perform as expected, the risk of increased costs and delays due to delays in initiation, enrollment , completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or clinical trial execution, and the expected timing of submission with regulatory authorities, MediciNova collaborations with third parties, the availability of funds to complete product development plans and capacity MediciNova ad to obtain third-party funding for the programs and raise sufficient capital when necessary, 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 to the year ended December 31, 2019 and your subsequent periodic reports on Form 10-Q and your current reports on Form 8-K. No undue reliance should be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova denies any intention or obligation to review or update these forward-looking statements.
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