\ ALS Research \ Encouraging trial results for KNS-760704
Presented by Dr. Merit Cudkowicz, an associate professor of neurology at the Massachusetts General Hospital of Harvard Medical School, the results of the two-part Phase 2 trial found that KNS-760704 was safe and well-tolerated in ALS patients for up to nine months. The results also showed trends suggesting that the drug may slow decline in the functional abilities of patients, such as walking, lifting, dexterity and survival.
In part one of the trial, 102 patients received the treatment or a placebo every day for 12 weeks. Patients taking KNS-760704 received the drug in one of three doses: low, medium or high. The drug showed a trend in slowing the rate of disease progression, depending on the dose, with the greatest benefit observed in the high dose group.
Part two of the trial saw 92 patients randomly assigned either low or high doses of KNS-760704 for 24 weeks. Results again suggested a dose-dependent trend in slowing the rate of disease progression, and, in addition, a trend toward a survival benefit in the high dose group compared to the low dose group.
“We are very encouraged by the results,” said Dr. Michael Bozik, president and CEO of Knopp Neurosciences Inc. “At the same time, we’re acutely aware of the work that remains to be done.” Further testing of KNS-760704 in a large, longer-term, carefully-monitored Phase 3 trial is needed to establish further evidence that the drug is safe and effective for ALS patients.
“Phase 2 clinical trials determine the size of the dose, the timing of the dose and how the drug is to be taken for the next phase of testing,” explains Dr. Belinda Cupid, research manager at the MND Association. “Although Phase 2 testing provides some indication of a drug’s ability to treat a disease, the number of patients involved at this stage is much too small for the findings to be relied upon,” said Cupid.
In consultation with global regulatory authorities, a Phase 3 testing of KNS-760704 in ALS may begin in mid-2010 at sites in Europe and North America under a protocol being developed by Knopp Neurosciences Inc.
Reacting to this news, Dr. Angela Genge, director of the Clinical Research Unit and the ALS Clinic at the Montreal Neurological Institute and Hospital, said “the field of new therapies for ALS is finally expanding with several new potential treatments on the horizon. I encourage every patient with ALS to join the fight by entering the proper clinical trials that will ultimately help defeat the enemy that is ALS.”
For more information on the development of KNS-760704, contact tom@knoppneurosciences.com.
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Encouraging trial results for KNS-760704
At the 20th Internal Symposium on ALS/MND, researchers presented the results of a Phase 2 clinical trial testing the safety and tolerability of a drug called KNS-760704 for use by ALS patients. KNS-760704 is a drug being developed by Knopp Neurosciences Inc. that is potentially thought to reduce the rate of decline in the functional capability of ALS patients by acting on the energy-supplying compartments within motor neurons to improve the supply and prevent cell death.Presented by Dr. Merit Cudkowicz, an associate professor of neurology at the Massachusetts General Hospital of Harvard Medical School, the results of the two-part Phase 2 trial found that KNS-760704 was safe and well-tolerated in ALS patients for up to nine months. The results also showed trends suggesting that the drug may slow decline in the functional abilities of patients, such as walking, lifting, dexterity and survival.
In part one of the trial, 102 patients received the treatment or a placebo every day for 12 weeks. Patients taking KNS-760704 received the drug in one of three doses: low, medium or high. The drug showed a trend in slowing the rate of disease progression, depending on the dose, with the greatest benefit observed in the high dose group.
Part two of the trial saw 92 patients randomly assigned either low or high doses of KNS-760704 for 24 weeks. Results again suggested a dose-dependent trend in slowing the rate of disease progression, and, in addition, a trend toward a survival benefit in the high dose group compared to the low dose group.
“We are very encouraged by the results,” said Dr. Michael Bozik, president and CEO of Knopp Neurosciences Inc. “At the same time, we’re acutely aware of the work that remains to be done.” Further testing of KNS-760704 in a large, longer-term, carefully-monitored Phase 3 trial is needed to establish further evidence that the drug is safe and effective for ALS patients.
“Phase 2 clinical trials determine the size of the dose, the timing of the dose and how the drug is to be taken for the next phase of testing,” explains Dr. Belinda Cupid, research manager at the MND Association. “Although Phase 2 testing provides some indication of a drug’s ability to treat a disease, the number of patients involved at this stage is much too small for the findings to be relied upon,” said Cupid.
In consultation with global regulatory authorities, a Phase 3 testing of KNS-760704 in ALS may begin in mid-2010 at sites in Europe and North America under a protocol being developed by Knopp Neurosciences Inc.
Reacting to this news, Dr. Angela Genge, director of the Clinical Research Unit and the ALS Clinic at the Montreal Neurological Institute and Hospital, said “the field of new therapies for ALS is finally expanding with several new potential treatments on the horizon. I encourage every patient with ALS to join the fight by entering the proper clinical trials that will ultimately help defeat the enemy that is ALS.”
For more information on the development of KNS-760704, contact tom@knoppneurosciences.com.
| Posted On: Friday, January 08, 2010 Modified: Friday, January 08, 2010 Category: ALS Research Posted By: |