US news roundup
pharmafile | March 30, 2007 | News story | Sales and Marketing |Â Â Â
Avicena starts phase III Parkinson's trial
Avicena Group said that the National Institute of Neurological Disorders and Stroke (NINDS) has initiated patient enrolment in a phase III efficacy trial of PD-02, the company's Parkinson's disease drug candidate.
PD-02 is an ultra-pure form of creatine made under strictly controlled drug manufacturing guidelines to not contain harmful neurotoxins that may be present in common types of creatine.
The NINDS has agreed to provide complete funding for the five-year trial to evaluate PD-02's potential to slow the progression of Parkinson's disease. Designed as a double-blinded and placebo-controlled protocol, the trial is expected to enrol more than 1,720 Parkinson's patients at over 50 trial sites across the US and Canada.
Belinda Tsao-Nivaggioli, Avicena's CEO, said: "The trial represents the world's largest clinical study in Parkinson's disease in terms of patient enrolment and is also one of the largest studies of Parkinson's disease undertaken by the NINDS."
Related links:
Avicena Group Inc: LSA Company report
Parkinson's Disease and Restless Legs Syndrome – Reformulations set to drive near-term growth
Parkinson's Disease – Review of Key Commercial Opportunities in the Symptomatic Treatment Market
Myriad Genetics makes progress with second phase III trial of Flurizan in Alzheimer's
Myriad Genetics has completed enrolment in the ActEarliAD, global phase III clinical trial of Flurizan for the treatment of Alzheimer's disease. The rapid clinical progress of Flurizan is crucial given that its rival, Neurochem's Alzhemed, has already finished its phase III trial, and both drugs are now racing to become the first disease-modifying therapy to market.
ActEarliAD is a multinational, randomised, double-blind, placebo-controlled study of Flurizan (tarenflurbil) in over 800 patients with mild Alzheimer's disease (AD). The 18-month study assesses Flurizan 800mg twice daily or placebo, with patients attending periodic physician visits for analysis of their performance on memory, cognition and behavioral tests.
The two primary clinical endpoints are the change in cognitive decline and function, as measured by the AD Assessment Scale-cognitive subscale, and changes in activities of daily living, as measured by the AD Cooperative Study-Activities of Daily Living inventory.
AD is a chronic progressive neurodegenerative disease that adversely affects higher cortical functions including memory, thinking and orientation. The disease mainly affects the elderly and has an estimated prevalence rate of 5.1 million in the seven major markets.
A treatment that can actively reverse, prevent, or cure AD currently remains the greatest unmet need. Earlier in March 2007, Myriad presented 24-month phase II results of Flurizan at the annual meeting of American Association for Geriatric Psychiatry.
Overall, 42% of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living. If approved by the FDA and EMEA, the disease-modifying potential of Flurizan will represent a crucial breakthrough in the treatment of AD, and will offer considerable hope to patients and their families.
With the exclusion of moderate AD patients and the sole use of the highest dose, Myriad is providing greater weight to allow demonstration of Flurizan's benefits than the original trial designs allowed. Datamonitor expects results from the global phase III trial to be announced towards the end of 2008 and predicts US market launch in late 2009.
The successful launch of Neurochem's Alzhemed in early 2009 is likely to restrict Flurizan's impact upon entering the market. However, Datamonitor forecasts Flurizan to achieve global sales of $932 million by 2014, with the novel mechanism of action expecting to see the drug being used in combination with the acetylcholine esterase inhibitors, such as the current market leader, Aricept (donepezil, Eisai/Pfizer), particularly when generic versions of these drugs reach the market.
Related links:
Myriad Genetics Inc: LSA company reports
Neurochem Inc: LSA company reports
BioGeneriX and Neose Technologies trial neutropenia drug
Ratiopharm Group subsidiary BioGeneriX and Neose Technologies have begun the second phase I clinical trial of GlycoPEG-GCSF, for the treatment of neutropenia associated with cancer chemotherapy.
The trial in healthy volunteers will compare a single, subcutaneously administered, fixed dose of GlycoPEG-GCSF versus the approved fixed dose of Amgen's Neulasta, the only currently marketed long-acting GCSF.
Interim results from the ongoing phase I clinical trial show a dose-dependent response for GlycoPEG-GCSF versus Neulasta with no reported serious adverse events. The first phase 1 study is a single-dose, single-blind, randomised, ascending-dose study, with subjects randomised to receive either GlycoPEG-GCSF or Neulasta.
"The results of our first phase I study to date support our belief that GlycoPEG-GCSF is an attractive candidate to enter the large and rapidly growing G-CSF category," said Elmar Schaefer, BioGeneriX's CEO.
Related links:
Neose Technologies Inc: LSA company reports
Amgen Inc: LSA company reports
Optimising Targeted Treatment in Cancer: Negotiating the Challenges to Success
The Cancer Market Outlook to 2010
