ANTISENSE, TEVA DATA: PHASE II MS DRUG SUCCESS
July 2nd 2008 01:35
Monday June 30, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: NEUREN UP 47%, PORTLAND DOWN 38.5%
* ANTISENSE, TEVA DATA SHOWS PHASE II MS DRUG SUCCESS
* NEUREN EXPECTS RESULTS 6 MONTHS SOONER
* MARC SINATRA’S BIOGUIDE BRIEFS: NEUREN, ANTISENSE
* VIRALYTICS MOVES TO US ANTI-CANCER VIRUS DRUG PRODUCTION
* BIOLAYER, PRINCE OF WALES INSTITUTE DEVELOP PARKINSON’S TEST
* USCOM SAYS RESEARCH BACKS USE IN .LIVER TRANSPLANT SURGERY
* ELANCO COMPLETES TRIAL OF ACRUX DOG PRODUCT
* BIOSIGNAL’S $US1.5m HAWKEN DEALS FALL THROUGH
* ANADIS WINS $US500k VISTECH GRANT
* AVEXA’S CEO DR JULIAN CHICK: ‘WE HAVE 12 MONTHS CASH’
* BONE PLACEMENT TO RAISE UP TO $2m
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ANTISENSE
Antisense and its Israeli partner Teva Pharmaceutical say that ATL/TV1102 “significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis”.
A randomized, double-blind, placebo-controlled phase IIa study met its primary endpoint showing a significant reduction by 54.4 percent (p = 0.01) in the cumulative number of new active brain lesions in patients taking ATL/TV1102 for eight weeks, compared to placebo, as measured by magnetic resonance images.
Based on the results, Teva said it intended to conduct additional pre-clinical and clinical research before continuing to a phase III study with the molecule.
The trial’s principal investigator Dr Volker Limmroth who is chairman of the Department of Neurology at Cologne City Hospitals said the results were “very encouraging and demonstrate a highly significant effect for ATL/TV1102 on disease activity in MS patients”.
Teva's group vice-president of innovative resources Moshe Manor said Teva planned to continue the development of the molecule to confirm its efficacy, a decision that triggers a $US4 million milestone payment to Antisense.
Antisense chief executive officer Mark Diamond was “very pleased” with the results.
“Achieving the primary endpoint to such a significant degree vindicates our efforts in developing this unique drug, the first to use antisense technology in the treatment of [multiple sclerosis],” Mr Diamond said.
“We now look forward to continuing the development of ATL/TV1102 for MS with one of the leading pharmaceutical companies in the world,” Mr Diamond said.
The ATL/TV1102 phase IIa trial was a randomized, double-blind, placebo-controlled clinical trial of ATL/TV1102.
Seventy-six patients received either ATL/TV1102 or placebo injections subcutaneously at a dose of 200 mg three times a week for the first week and twice weekly over an additional seven weeks after which they were monitored for an additional eight weeks.
Assessment was by monthly magnetic resonance imaging (MRI) brain scans.
The goal of the trial was to obtain preliminary evidence of ATL/TV1102’s effectiveness in reducing multiple sclerosis-related MRI brain lesions and assess its safety profile.
For the study’s primary endpoint, ATL/TV1102 showed a significant 54.4 percent reduction in the cumulative number of new active lesions on weeks four, eight and 12 (p = 0.01).
In addition, patients taking ATL/TV1102 experienced a 65 percent reduced cumulative number of brain lesions on weeks four, eight, and 12 (p = 0.0053).
ATL/TV1102 demonstrated an increasing effect with time on the reduction of new active lesions over 12 weeks, namely one month after the completion of dosing.
This extended duration of activity post-dosing was anticipated based on the drug’s long (more than three weeks) half-life and would support the proposition of less frequent dosing than the twice weekly dosing employed in the current trial though this would need to be confirmed in future clinical studies.
In general, ATL/TV1102 was well-tolerated. Potentially attributable adverse events included injection site reactions which were mild to moderate and thrombocytopenia.
Thrombocytopenia was reversible after treatment interruption returning to within normal ranges and was not accompanied with any clinical consequences.
The companies plan to present the results of this study at future scientific meetings.
Multiple sclerosis is the leading cause of neurological disability in young adults.
It is estimated that 400,000 people in the US are affected by the disease and that more than two million people are affected worldwide.
It is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves.
Antisense was up 2.5 cents before closing up 1.4 cents or 23.33 percent to 7.4 cents.
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