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New Medical Therapies™

Stroke

October 28, 2013

Acorda Therapeutics issued results from a phase II trial of dalfampridine extended release tablets, 10mg (dalfampridine-ER) in 83 participants who had experienced an ischemic stroke at least six months prior to treatment and had chronic motor deficits. Dalfampridine-ER was well-tolerated and improved walking, as measured by the Timed 25-Foot Walk test (T25FW). The overall rate of treatment-emergent adverse events was 54.5% and 37.0% for dalfampridine-ER and placebo, respectively. The most common adverse events reported were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo). A phase IIb/III study has been planned, pending successful conclusion of a multi-dose, pharmacokinetic study of a once-a-day formulation of dalfampridine-ER, as well as discussions with the FDA.

February 13, 2012

Remedy Pharmaceuticals reported results from a phase IIa trial of RP-1127 for the treatment of ischemic stroke. This multi-center, prospective, open label trial, GAMES-Pilot, enrolled 10 subjects with severe anterior circulation ischemic stroke who were likely to experience clinically significant brain swelling. The subjects received RP-1127 as an intravenous bolus followed by infusion for 72 hours. Results were compared to historical data. Treatment with RP-1127 showed an incidence of major swelling in 12.5% of the subjects versus 88% in the historical group. No significant hemorrhages were observed versus 30% in the historical group and the proportion of subjects without severe disability or death at 30 days was 87.5% versus one-third in the historical group. Follow up Magnetic Resonance Imaging showed absence of midline shift and ventricle compression, striking preservation of sulci, and preservation of white matter.

March 2, 2009

PhotoThera reported positive results from a phase III trial of NeuroThera transcranial laser therapy for the treatment of acute ischemic stroke. This double-blind, placebo controlled trial, dubbed NEST-2 (NeuroThera Efficacy and Safety Trial-2), enrolled 660 subjects who had moderate to severe strokes and had not received tissue plasminogen activator. NeuroThera was initiated within 24 hours after stroke onset. The primary efficacy endpoint was a favorable 90-day score of 0-2 using the modified Rankin Scale (mRS). NeuroThera achieved a favorable outcome in 36.3% of subjects compared to 30.9% of subjects in the placebo group (p-value 0.094). Mortality rates and serious adverse events did not differ between groups. A post-hoc analysis of 434 subjects who suffered moderate to moderately severe strokes showed a favorable outcome in 51.6% of subjects in the neuroThera group compared to 41.9% of those in the placebo group, reaching statistical significance (p-value 0.044).

October 6, 2008

Thrombogenics released positive results from a phase II trial of microplasmin for the treatment of acute stroke. This multi-center, double-blinded, placebo-controlled, ascending-dose clinical trial, dubbed MITI IV (Microplasmin in Treatment of Ischemic stroke - IntraVenous), enrolled 40 subjects. The subjects received three dose regimens of microplasmin (2, 3, and 4 mg/kg) or placebo administered intravenously four to 12 hours following onset of acute ischemic stroke. Safety and preliminary efficacy data, measured using radiographic assessments and plasma surrogate biomarkers, were assessed at seven days and 30 days post-treatment. Approximately 25% of subjects treated with microplasmin had reperfusion within eight hours of being treated, compared to 10% of the placebo-treated subjects. In a subgroup of subjects who had more severe vascular blockages, 33% who received microplasmin achieved reperfusion compared with 14% of those treated with placebo. In addition, a statistically significant improvement in the level of damage to the blood brain barrier was observed in the microplasmin groups compared to placebo. Microplasmin was generally well tolerated with no evidence of increased bleeding risk. Based on the results Thrombogenics plans to move forward with the development of microplasmin.

March 3, 2008

Stem Cell Therapeutics issued positive results from a phase IIa trial of NTx-265 for the treatment of acute ischemic stroke. This open-label study, dubbed BETAS (Beta-hCG + Erythropoietin in Acute Stroke), enrolled thirteen subjects at two sites in California. The subjects received treatment with NTx-265 within twenty four to forty eight hours of stroke onset. Of the thirteen subjects, eight completed the ninety day assessment term and each of them showed a clinically relevant improvement in their National Institutes of Health Stroke Scale (NIHSS) score of four points or greater. The average baseline NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved at day ninety to 2.5 plus/minus 1.8, an improvement in NIHSS score of 5.8 plus/minus 2.5 points. Five of these eight subjects had a day ninety Barthel Index score of 95-100 (out of 100); consistent with excellent outcome. NTx-265 also led to positive specific assessments of neurological recovery, including the Arm Motor Fugl-Meyer Scale, an arm motor recovery assessment; Trailmaking A test, a measure of cognitive function; and measures of neglect and aphasia. In addition, NTx-265 decreased the size of the infarct in six out of eight subjects overall, given a mean decrement in all eight of about 10%. A phase IIb study is expected to commence later in 2008.

June 11, 2007

Cardiome and Astellas issued positiveresults from a phase III trial of intravenous vernakalant forthe treatment of atrial fibrillation or atrial flutter between 24 hours and 7days following coronary artery bypass graft (CABG) or valve replacement surgery.This trial, dubbed ACT 2, enrolled 190 subjects who received vernakalant or placebo.The primary endpoint, conversion to normal heart rhythm within 90 minutes, wasreached. Of the subjects receiving vernakalant, 45% achieved this endpoint comparedto 15% of placebo subjects within the same time period (p=0.0002). Of the subjectswho converted to normal heart rhythm, the median time to conversion was 12 minutesfrom the initiation of dosing. A NDA for vernakalant (iv) is currently under reviewby the FDA.

Forest and Paion reported negative results from a phase III trial of desmoteplase, dubbed DIAS2, for the treatment of Acute Ischemic Stroke. This blinded, randomized, placebo-controlled, dose-ranging trial enrolled 186 subjects internationally. Subjects received either placebo or desmoteplase (90 mcg/kg or 125 mcg/kg) as an intravenous bolus 3-9 hours after onset of stroke. The primary endpoint was clinical improvement at day 90 when compared to placebo. This was defined for each subject as achievement of all three of the following criteria: improvement of greater than or equal to 8 points from baseline on the National Institutes of Health Stroke Scale (NIHSS) or NIHSS score less than or equal to 1; Modified Rankin Scale (MRS) of 0-2 and Barthel Index (BI) score of 75 - 100. Those who reached all three endpoints were defined as responders. This primary endpoint was not met. Clinical response was seen in 47.7% of the subjects receiving 90 mcg/kg of desmoteplase, 36.4% of the subjects receiving 125 mcg/kg of desmoteplase and 46% of those on placebo. The companies plan to thoroughly review the results in order to determine a future course of action.

October 30, 2006

AstraZeneca reported negative results from a phase III trial, dubbed SAINT II, of Cerovive (NXY-059) for the treatment of stroke related disabilities. This multinational, multi-centre, double-blind, randomized, placebo-controlled parallel-group trial enrolled 3,200 subjects. Each subject received Cerovive or placebo up to six hours after the onset of stroke symptoms. Subjects were then measured using the modified Rankin Scale. The primary endpoint, statistical significance in the reduction of stroke related disability in the subjects treated with Cerovive versus placebo, was not met (p=0.33, odds ratio 0.94). Secondary endpoints were not met as well with no statistically significant improvement in neurological status versus placebo on the National Institute of Health Stroke Scale (p=0.70). In addition, Cerovive, when administered with the approved thrombolytic agent, rt-PA, showed no evidence of lowering the incidence of symptomatic intracranial hemorrhage (p=0.56). Based on the results AstraZeneca has discontinued development of Cerovive.

Somaxin released positive results from a phase III trial of Silenor for the treatment of transient insomnia. This randomized, double-blind, placebo-controlled, multi-center, parallel group trial enrolled 565 subjects who received 6 mg of Silenor or placebo. Treatment was well tolerated with the incidence of serious adverse events low and mild in nature. Efficacy data revealed that treatment with Silenor led to statistically significant results when compared to placebo in a number of endpoints, including: latency to persistent sleep with an improvement of 13 minutes (p<0.0001), latency to sleep onset, an improvement of 16 minutes (p<0.0001), wake after sleep an improvement of 40 minutes (p<0.0001) and total sleep time with an improvement of 51 minutes (p<0.0001). Somaxin is currently conducting two other phase III trials of Silenor and plans to file a NDA in the third quarter of 2007.

May 9, 2005

AstraZeneca and Renovis announced positive results of a phase III trial, dubbed SAINT I, of Cerovive (NXY-059), their investigational neuroprotectant for the treatment of ischemic stroke. Preliminary results met their primary endpoint, producing a significant reduction in overall patient disability following stroke, as measured by the Modified Rankin Scale, versus placebo (p=0.038). The trial did not yield significant difference vs. placebo in the change in neurological impairment following stroke, as measured by the National Institute of Health Stroke Scale (NIHSS). Overall adverse events were similar in profile and frequency to placebo. This randomized, double-blind, placebo-controlled study treated 1700 subjects across 400 sites in 40 countries. The companies announced that these results, in combination with other ongoing and recently completed late-stage trials of the drug, support continued development, with regulatory submission planned for the second half of 2006.

September 27, 2004

Avant Immunotherapeutics has published the results from a phase II trial of their cardioprotective investigational drug TP10 in the journal Circulation. The trial did not meet its primary endpoint, a significant decrease in mortality or acute myocardial infarction following cardiopulmonary bypass (CPB) during cardiac surgery. However, when data were analyzed for male patients only, the drug was successful in both outcomes, reducing mortality by 36% in all men and by 43% in CABG men. The drug did demonstrate significant pharmacodynamic activity on its target in both men and women. This multi-center, double-blind, placebo-controlled study enrolled a total of 564 high risk men and women undergoing cardiac surgery including CPB. Avant announced that it plans to initiate a second, all-female phase II trial, in addition to phase III testing.

Medicure has announced positive results from a phase I trial of a new IV formulation of their lead compound MC-1, for the treatment of cardiovascular emergencies, including stroke and acute coronary syndrome. The drug was found to be safe and well tolerated in healthy volunteers, and, similar to the effect observed with the drug’s oral formulation, did not produce any significant adverse cardiovascular effects, a common concern with other similar products. This trial and the IV formulation of the drug were designed to expand the clinical potential of MC-1, and permit use of the drug both pre-operatively, as a cardioprotective, and as an intervention therapy in acute cardiovascular events.

July 5, 2004

Novo Nordisk has announced positive results of their phase IIb study of NovoSeven for the treatment of intracerebral hemorrhage (ICH). NovoSeven is currently approved as a treatment for acute bleeding in hemophilia. Results have shown that the drug led to a significant reduction in hematoma growth, compared to placebo, and significantly improved neurological and functional outcomes following an ICH incident. The double-blind, dose-response study enrolled a total of 400 subjects in 20 countries; subjects with spontaneous ICH confirmed by CT scan within three hours of symptom onset randomized to receive either NovoSeven or placebo, in addition to standard therapy. Follow-up CT scans, performed at 24 and 72 hours, found that NovoSeven significantly and dose-dependently reduced hematoma expansion, and observations at 15 and 90 days found significant improvement in severity score on neurological function tests in the NovoSeven group. Novo Nordisk announced plans to file supplementary regulatory submissions based upon this data.

May 10, 2004

Neurochem reported positive results from a phase II trial investigating Cerebril, an amyloid beta protein binder for the treatment of hemorrhagic stroke. Results showed that compounds in the pharmacokinetic profile of Cerebril were detected in the cerebrospinal fluid, suggesting its ability to cross the blood-brain-barrier. The most frequent adverse events were nausea and vomiting, and were mild to moderate at all doses. The randomized, double-blind study enrolled 24 subjects with cerebral amyloid angiopathy at five sites in the US. Subjects received three different daily doses of Cerebril (100, 200 and 300 mg) for twelve weeks. Results were reported at the American Academy of Neurology's 56th Annual Meeting. The study evaluated the safety, tolerability, and pharmacokinetic profile of Cerebrilin Hemorrhagic Stroke due to Cerebral Amyloid Angiopathy (HS-CAA) patients who experienced lobar cerebral hemorrhage.

March 17, 2003

D-Pharm reported positive results from a phase II saftey trial investigating DP-b99, a neuroprotectant agent for the treatment of stroke. Rates of mortality, serious adverse events and overall adverse events were not higher in the DP-b99 group compared to placebo and no major side effects were attributed to the treatment. Data indicates that DP-b99 was safely administered in this study. In addition, efficacy improvements were observed in the clinical neurological scale scores 2, 7 and 30 days after the stroke. The randomized, double blind, placebo-controlled study was designed to test whether the drug could be safely used within a 12-hour time window following a stroke and to provide further pharmacokinetics information.

March 10, 2003

Texas Biotechnology and GlaxoSmithKline reported positive results from a phase II trial investigating Argatroban, a synthetic direct thrombin inhibitor for the treatment of ischemic stroke. Results showed the drug produced Intracranial Hemorrhaging (ICH) at a rate comparable to placebo. The primary endpoint of safety, defined as symptomatic intracranial hemorrhage within 30 days, confirmed by computerized tomography, was successfully met with no statistically significant differences between the treatment group vs. placebo. The secondary endpoints, defined as asymptomatic ICH, major systemic hemorrhage, minor systemic bleeding, and efficacy for each group and stroke showed no significant differences from placebo. The double- blind, randomized study, called ARGIS-I (Argatroban in Acute Ischemic Stroke), enrolled 176 ischemic stroke subjects. Subjects were given Argatroban or placebo to achieve two different levels of anticoagulation within 12 hours from symptom onset.

December 17, 2001

Interim results from a phase II trial for stroke prevention indicate that AstraZeneca's Exanta (ximelagatran) showed 0.9 strokes and 0.4 transient ischemic attacks (TIAs) per 100 treatment years (three events) compared to 2.6 strokes and 2.6 TIAs per 100 treatment years (four events) for warfarin. The long-term trial, known as SPORTIF IV, compared Exanta to warfarin for the prevention of strokes in subjects with chronic nonvalvular atrial fibrillation (NVAF). In the trial, 125 subjects with chronic NVAF and at least one additional stroke risk factor received fixed-dose Exanta and 42 subjects received warfarin.


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