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Survey: Neurologists Skeptical About Launch Potential of New Pharmacotherapies for Ischemic Stroke
Decision Resources, a research and advisory firm, reports that, in light of repeated clinical trial failures of investigational treatments, neurologists remain skeptical about the launch potential of pharmacotherapies in clinical development for the acute or post-acute treatment of ischemic stroke. As a result, the market for ischemic stroke therapies is expected to continue to be a graveyard for new product development in the U.S., Europe, and Japan.
Interviewed neurologists expressed uncertainty about the probability of success for thrombolytic desmoteplase (Lundbeck) — currently the only new drug in phase III development — in its redesigned pivotal clinical-trial program. The approval of desmoteplase for use within 3 to 9 hours after the onset of stroke could represent one of the most important therapeutic achievements in stroke in more than a decade, while expanding the number of ischemic stroke patients with access to acute therapy, the researchers say.
Most of the interviewed experts expressed limited optimism that neuroprotectants will be effective in the treatment of ischemic stroke, given countless failures among such agents in clinical trials — including the recent discontinuation of DP-b99 (D-Pharm). Instead, interviewed neurologists agreed that new directions in neurorestorative therapy to aid in post-stroke recovery need to be explored. Although success in this arena is far from certain, numerous companies are investigating new approaches to stimulate neuroplasticity using growth factors, such NTx-265 (Stem Cell Therapeutics), or innovative technologies, such as the NeuroThera laser system (PhotoThera). Meanwhile, several developers — including Aldagen, ReNeuron, SanBio/Teijin, and Stemedica — have initiated the first human clinical trials of cell-based treatments.
Investigators are also focused on improving the utility of the recombinant tissue plasminogen activator (rt-PA) alteplase (Activase; Genentech; Actilyse, Boehringer Ingelheim) — the current standard of care in acute ischemic stroke — through new research, including the use of advanced imaging to expand the treatment window beyond the currently accepted 4.5 hours. Meanwhile, new reperfusion strategies — such as the ClotBust ER Sonolysis Headframe System (Cerevast), NeuroFlo (CoAxia), and the Ischemic Stroke System (BrainsGate) — offer nonpharmacological approaches alongside currently approved neurothrombectomy devices from companies such as Concentric Medical, Penumbra, and ev3.
According to analyst Bethany Kiernan, PhD, growth in drug sales and drug-treatment rates in the acute ischemic stroke market will occur primarily as a result of the gradually increasing use of rt-PA (aided by a modestly expanded treatment window), continued improvements in the delivery of stroke care, and a rising stroke incidence.
Source: Decision Resources; November 6, 2012.