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pharmafile | July 27, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
BioMS's multiple sclerosis trial gets positive review
BioMS Medical's relapsing-remitting multiple sclerosis trial has received a positive review from the data safety monitoring board, which recommends that the trial should continue.
This was the first of several regularly scheduled reviews by the data safety monitoring board (DSMB) that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
The phase II, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting multiple sclerosis. The 15-month trial is fully enrolled with approximately 215 patients at 24 sites in six countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 versus placebo as measured by relapse rate, MRI activity and disease progression.
Related links
Pipeline Insight: Multiple Sclerosis – The oral revolution
Multiple Sclerosis – Continued growth makes the MS market a highly attractive investment
GPC Biotech's prostate cancer drug hits approval delay
GPC Biotech's shares fell by around 33% after an advisory panel in the US said that regulators should wait for more data before deciding to approve the company's prostate cancer drug.
GPC Biotech's market value has plummeted nearly E180 million ($247 million) because of the panel's vote against its Orplatna drug.
Although the company said that it does have sufficient cash to get to the survival endpoint, it does not expect to have an analysis from the 950-patient study for another year.
The drug, which is the company's lead product candidate, is designed for prostate cancer patients who no longer respond to chemotherapy or hormone treatments.
The FDA is expected to come to a final decision by mid-August 2007.
Related links
GPC Biotech AG: LSA company report
Stakeholder Insight: Prostate Cancer – A Prostrate Market Waiting for Innovations
Icagen files IND for epilepsy treatment compound
Icagen has filed an investigational new drug application with the FDA for its novel small molecule compound for the treatment of epilepsy.
The company says ICA-105665 is an activator of subtypes of KCNQ ion channels, which are attractive targets for the treatment of epilepsy based on their function and genetic linkage to a seizure disorder.
In preclinical studies, ICA-105665 was active in animal models predictive of efficacy for the treatment of partial seizures, generalised seizures and treatment-resistant seizures. In addition, the compound has also been shown to have activity in models of neuropathic and inflammatory pain.
"KCNQ channels are particularly promising targets for the treatment of epilepsy, and, provided that our IND is accepted, we believe that ICA-105665 will be the only compound selective for KCNQ channels currently in clinical development," commented Seth Hetherington, SVP of clinical development and regulatory affairs at Icagen.
ICA-105665 will be administered orally and is intended to be developed as a chronic therapy for patients with epilepsy. Provided that the IND is accepted, during the third quarter of 2007 Icagen plans to initiate a Phase I clinical trial, which will be a double-blind, placebo controlled study conducted in healthy male volunteers to assess the safety, tolerability and pharmacokinetics of the compound.
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MERIT trial leaves role of Pfizer's Celsentri unclear
With Pfizer's novel HIV treatment Celsentri failing to demonstrate non-inferiority to Bristol-Myers Squibb's Sustiva in the MERIT trial, the drug's chances of easily securing a first-line use indication look rather bleak. Given this, Pfizer must now establish whether Celsentri should be used for first-line therapy and the best context for this use if so.
Celsentri (maraviroc) received an FDA approvable letter in June 2007, with a request for additional information (rather than further trials). This must have been a small relief, in the context of the tribulations that the CCR5 inhibitor class as a whole, and Celsentri in particular, has experienced. New HIV classes are in much demand, but both GlaxoSmithKline and Schering-Plough faced major problems with their CCR5-inhibitor candidates. GlaxoSmithKline's aplaviroc was discontinued, and malignancies continue to dodge phase II trials of Schering-Plough's Vicriviroc.
CCR5-inhibitors are only active in so-called R5-tropic strains of HIV, limiting the patient population for any drug in this class. CCR5 tropic strains are much more common in treatment-naive patients (80-85%) than in treatment-experienced patients (50-60%), making early lines of therapy the natural home for this drug class. Pfizer therefore undertook the MERIT trial to evaluate Celsentri's potential to be positioned against Sustiva in treatment-naive patients.
Related links
Pfizer Inc: LSA company report
Bristol Myers-Squibb: LSA company report
GlaxoSmithKline Plc: LSA company report
Schering-Plough Corp: LSA company report
Orexigen obesity drug candidate successful in phase IIb
Orexigen Therapeutics has reported positive top-line results at the 24-week primary endpoint of its phase IIb trial of Empatic, one of its two obesity drug candidates. The trial demonstrated, across each of the six Empatic treatment arms, statistically significant weight loss against placebo.
The randomised, double-blind, placebo-controlled trial, conducted with the company's novel, sustained-release (SR) formulation of zonisamide paired with bupropion SR, evaluated various ratios of bupropion and zonisamide in 620 patients.
At the highest dose tested, patients experienced 8.6% weight loss from baseline compared to 1.1% weight loss for placebo in the intent-to-treat group, and 10.3% weight loss from baseline compared to 1.2% weight loss for placebo in the completer group. In addition, the trajectory of weight loss for all treatment arms appeared to continue downward through 24 weeks.
Orexigen says results of the trial indicated that Empatic is safe and generally well tolerated. The pooled discontinuation rate for side-effects across the six Empatic dosages was 14%, which was meaningfully lower than the rate in the company's previous trial employing an older immediate-release form of zonisamide (37%).
"These trial results illustrate that we can delay the early weight loss plateau often seen with dieting and many existing pharmaceutical approaches and also improve tolerability with a sustained-release formulation of zonisamide," said Orexigen president and chief executive, Gary Tollefson. "If the magnitude of weight loss evident in this trial continues to be seen, we believe that Empatic may be particularly useful in severely obese individuals."
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Commercial and Pipeline Perspectives: Obesity – Lack of Reimbursement Limits Market Potential
Obesity Therapeutics: Understanding market dynamics (presentation)
