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Newron Announces Positive Results With Ralfinamide From Phase II Trial in Neuropathic Pain.

MILAN, Italy, October 26 /PRNewswire/ -- Newron Pharmaceuticals SpA, a research and development company focused on novel CNS therapies, announced today positive results in a Phase II clinical trial to assess tolerability and preliminary efficacy of ralfinamide in patients suffering from neuropathic pain. Neuropathic pain is a type of chronic pain caused by damage to nerves.

Overall ralfinamide was well tolerated up to the maximal dose with absence of any consistent pattern of clinically relevant adverse events regarding vital signs, ECG and other laboratory values. The primary efficacy measure, pain Visual Analogue Scale (VAS) showed a statistically significant improvement (26% vs baseline). VAS is a widely accepted instrument to subjectively assess pain intensity.These results were also supported by data obtained from provoked allodynia, pin prick tests, Clinical Global impression (CGI) and Patient Global Impression (PGI). These scales are also used as a measure of clinically meaningful changes in subjective events.

"These preliminary phase II data are very encouraging and provide strong foundations for future clinical trials of ralfinamide in this difficult to treat condition," stated Prof. Ruggero Fariello, MD, Newron's CSO. "The data not only show ralfinamide to be safe and well tolerated, but also point to a potentially effective new way of treating neuropathic pain originating from several different sources. In a market believed to be significantly underestimated both in terms of number of patients and availability of effective therapies, ralfinamide, one of the cornerstones to Newron's product pipeline, could offer new hope."

Details of the Study

This phase II tolerability study was designed to obtain preliminary safety and efficacy data from the treatment of patients with neuropathic pain of mixed causes with ralfinamide. A pilot, single-center, observer-blinded study was conducted at the University of Vienna (Austria) in 18 patients who were administered ascending oral doses of ralfinamide (80-160-320 mg/day) for 4 weeks. Patients were enrolled if they were affected by neuropathic pain induced by one of the following causes: traumatic or ischemic nerve roots disease, nerve roots compression in spine disease, post herpetic neuropathy, diabetic neuropathy, nerve entrapment, traumatic mononeuropathy and polyneuropathy. Efficacy was assessed mainly by the use of patient-rated scales, such as VAS, which are designed to assess the impact of pain on sleep and daily activities.

About Neuropathic Pain

Neuropathic pain is a type of chronic pain initiated or caused by a primary lesion of nervous system. While epidemiological studies indicate the incidence of neuropathic pain is 1%, most experts conclude this figure is most certainly an underestimate. Conditions associated with a high incidence of neuropathic pain include diabetes (10%), post-herpetic neuralgia (25%) and others. Neuropathic pain does not respond well to conventional pain therapy and may worsen over time.

Pain is felt when special nerve terminals called nociceptors are stimulated. Following peripheral nerve injury, changes occur in the nervous fibers transmitting non-nociceptive stimuli, leading to neuropathic pain. Among these changes is an irregular membrane excitability, sustained by profound alteration in the pattern of the sodium channel expression, including up-regulation of certain channels not normally observed in nociceptors, and down-regulation of others, thereby causing the brain to recognize pain from sources not normally painful.

About Ralfinamide

Ralfinamide is a novel compound with potent sodium channel blocking properties. This investigational drug exerts both voltage- and use-dependent inhibitory effects on TTXr and TTXs sodium currents, with preference for TTXr currents.

In animal models of neuropathic pain, ralfinamide has demonstrated a strong anti-nocicpetive effect, by a) dose-dependently reducing licking time (formalin test in mice), b) decreasing mechanical allodynia and thermal hyperalgesia (complete Freund's adjuvant test in rats), c) increasing mechanical allodynia threshold (chronic spinal nerve ligation test in rats and chronic constriction injury model in rats). These experiments also indicated that the oral anti-nociceptive effect of ralfinamide is retained following chronic treatment without tolerance.

About Newron Pharmaceuticals

Newron Pharmaceuticals SpA is a research and development company focused on novel ion channel-based therapies for diseases of the Central Nervous System (CNS), particularly Parkinson's disease, epilepsy and pain. Newron has initiated Phase III clinical trials in Parkinson's disease with safinamide, a unique molecule with multiple mechanism of action. Safinamide is also in Phase II clinical development for epilepsy and restless leg syndrome (RLS). Furthermore, a Phase II placebo controlled trial with ralfinamide is on going. Newron's clinical pipeline is supported by a broad portfolio of early stage proprietary compounds generated by our ion channel drug discovery platform.

Newron is headquartered in Bresso, near Milan, Italy. For further information visit http://www.newron.com/.

CONTACT: For further information, please contact: Newron Pharmaceuticals, Luca Benatti, Chief Executive Officer, Tel. +39-02-61034604 (Emanuela Germi PA to Luca Benatti) Fax +39-02-61034654 Halsin Partners, Mike Sinclair, Tel. +44-(0)-870-747-0880 Hill & Knowlton Italia, Valerio Vago, Tel. +39-02-31914244
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Publication:PR Newswire
Geographic Code:4EUIT
Date:Oct 26, 2004
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