Article about MN-166 Phase II trial

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Article about MN-166 Phase II trial

Postby dignan » Fri Sep 02, 2005 10:37 am

This is one that's been talked about before, but here is a new article.



Doctors to Test Stroke Drug for MS

09-02-05 - A medication currently available in Southeast Asia to treat asthma and vascular disorders in the brain is now undergoing clinical testing as a possible therapy for multiple sclerosis. The drug is known as Ketas® (ibudilast) in Japan and Korea. But it uses a code name, MN-166, in its current clinical scrutiny as a possible MS treatment.

A Promising MS Drug?
The trials—the latest is a Phase 2 study that just completed patient recruitment—are sponsored by the drug's manufacturer, San Diego-based MediciNova. "MN-166 may present a significant advance in the treatment of relapsing-remitting MS," said Richard Gammans, PhD, the company's Chief Development Officer. "It has a proven record of safety and tolerability, and has the major advantage of oral dosing."

The drug works by inhibiting phosphodiesterase IV (PDE4), an enzyme that blocks the activity of a hormone in the body that mediates some cellular functions.1 In the case of MS, inhibiting PDE4 increases levels of this hormone, which results in decreased inflammation. Inflammation is a hallmark of multiple sclerosis. In the central nervous system where damage occurs as a result of the disease, inflammation is a common side effect.2

A Varying Pathology
Relapsing MS is the most common form of the disease, affecting an estimated 85 percent of patients. It's characterized by clearly defined relapses, or symptom flare-ups, followed by partial or complete recovery periods. The three other forms of MS include the following:

• Primary-Progressive-Characterized by a slow and continuous worsening of disease from the moment it strikes.
• Secondary-Progressive-Characterized by an initial phase in which relapses occur followed by recovery. But the disease then becomes steadily worse over time with or without occasional flare-ups, minor remissions, or plateaus.
• Progressive-Relapsing-Characterized by a steadily worsening form of the disease from its onset, but which coincides with acute relapses with or without recovery. The difference between this form of MS and the relapsing form is that the periods between relapses are characterized by continuous disease progression.3

Promising Findings So Far
According to MedicaNova, MN-166 showed "encouraging" results in small, open label, studies with patients who were diagnosed with relapsing-remitting MS. "This Phase 2 study is being conducted in nine countries in Eastern Europe, and will compare two oral doses of MN-166 to placebo in 300 patients with relapsing-remitting MS," said Gammans.

In the study, investigators will measure the frequency of MS lesion reduction, by taking MRI measurements of each patient. MRI (magnetic resonance imaging) is a diagnostic test used to assess the number and size of lesions in the central nervous system as a measure of MS activity.

Yearly relapses, as well as functional ability will also be tested in the study, according to MediciNova.

Other Uses for the Medication
In Japan, Ketas is prescribed as a therapy for people who've experienced a stroke, or who have been diagnosed with bronchial asthma. The drug works in these cases by inhibiting blood clotting, improving blood flow in the brain, and easing allergic reactions. Experts say in these cases, the drug may release nitric oxide, a blood vessel dilator, or prostacyclin, a powerful inhibitor of blood clotting.4

MediciNova reached a licensing agreement with Kyorin Pharmaceuticals in Tokyo to market MN-166 worldwide—except in Japan, China, Taiwan, and South Korea—as a treatment for multiple sclerosis, pending the outcome of the upcoming Phase 2 trial, as well as future clinical trials of the drug.

MediciNova has not stated when it expects the Phase 2 trial to conclude.

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