On March 28, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that it plans to initiate a pilot study to evaluate MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy (Press release, MediciNova, MAR 28, 2018, View Source;p=RssLanding&cat=news&id=2340230 [SID1234525383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The clinical trial is a collaborative effort between MediciNova, Inc. and Dr. Janette Vardy, Professor of Cancer Medicine, University of Sydney Concord Cancer Centre in Australia. The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment for individuals with chemotherapy-induced peripheral neuropathy. A Concord Cancer Centre Research grant will provide funding for this study and MediciNova will provide study drug.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, "We are excited to collaborate with Dr. Vardy on this grant-funded study to explore the potential of MN-166 as a pharmacotherapy for chemotherapy-induced peripheral neuropathy. There is a large unmet medical need for patients with this disorder."
Dr. Janette Vardy, the Principal Investigator for this study, commented, "This is an exciting new project and we are enthusiastic to partner with MediciNova to evaluate MN-166 in chemotherapy-induced peripheral neuropathy patients. As chemotherapy-induced peripheral neuropathy is believed to be caused by glial activation, we believe ibudilast’s ability to reduce glial activation could be beneficial in treating this common disorder following chemotherapy."

About the Trial
This is a prospective, open-label, sequential cross-over pilot study assessing acute neurotoxicity, chemotherapy-induced peripheral neuropathy, and drug interactions of ibudilast in 20 patients with metastatic gastrointestinal cancer (colorectal cancer and upper gastrointestinal cancers) who are receiving oxaliplatin.
The study aims to determine: 1) whether ibudilast can prevent the development of acute neurotoxicity in patients receiving oxaliplatin for the treatment of metastatic gastrointestinal cancer; 2) the effect of ibudilast co-administration, if any, on the pharmacokinetics of oxaliplatin and fluorouracil; and 3) whether ibudilast might decrease the severity of chemotherapy-induced peripheral neuropathy
.
Participants will undertake pharmacokinetics assay and neurotoxicity assessment for a cycle of their usual chemotherapy, followed by identical assessments the following cycle with concurrent administration of oral ibudilast 30 mg twice daily. Assessments for chemotherapy-induced peripheral neuropathy will occur at baseline, day 3 of chemotherapy, end of each cycle, and 3 months after baseline, and will be compared to determine a clinical benefit, as well as safety and medication adherence.

About Concord Cancer Centre
Concord Cancer Centre, part of the University of Sydney, is based at Concord Repatriation General Hospital, a major tertiary hospital in Sydney Local Health District in Australia. Concord Repatriation General Hospital is one of the best cancer treatment and research facilities in New South Wales.

About Chemotherapy-Induced Peripheral Neuropathy
Peripheral neuropathy is a set of symptoms caused by damage to the nerves that are away from the brain and spinal cord. These distant nerves are called peripheral nerves. Some of the chemotherapy and other drugs used to treat cancer can damage peripheral nerves that carry 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 commonly, people complain of "pins and needles" in their toes and fingers. CIPN may affect cancer outcomes due to reductions in chemotherapy dosing and/or premature treatment discontinuation and have a profound impact on quality of life and survivorship. According to a meta-analysis which included more than 4,000 patients, CIPN prevalence was 68% when measured in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more ("Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis," Seretny M et al 2014). Long-term neurotoxicity is an important issue for the growing number of cancer survivors, with the highest number of affected patients having been treated for breast and/or colon cancer.

About Oxaliplatin-induced Peripheral Neuropathy
Oxaliplatin is shown to improve survival of patients with colorectal cancer and other gastrointestinal cancers. The neurotoxicity seen with oxaliplatin treatment, in the form of the acute and chronic syndrome, ranks among the most frequent non-hematological toxicity due to this treatment. The acute, transient neurotoxicity occurs in nearly all patients, is rapid in onset, and occurs during or within hours of the oxaliplatin infusion. The dose-limiting, cumulative sensory neurotoxicity may be severe enough to limit patients from performing their activities of daily living. A proposed mechanism for this process is central and dorsal root ganglion neuroinflammation caused by oxaliplatin.

About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in substance use disorders, neurodegenerative diseases (e.g., ALS and progressive MS), and chronic neuropathic pain. MediciNova is developing MN-166 for various neurological conditions such as progressive MS, ALS and substance abuse/addiction