Cobalis Drug Enters Phase III Clinical Trials
Cobalis Corp. (OTC BB: CLSC), a pharmaceutical development company specializing in anti-allergy medications, announced that the Company has successfully completed the enrollment of a total of 1,551 patients across two identical Phase III Clinical Trials of its anti-allergy medication PreHistin(R) in patients with moderate to moderately severe seasonal allergic rhinitis. The trials are being conducted at 23 sites across the central, southern and eastern United States.
It is expected that the ten-week trials will be completed in November. Cobalis expects to report final data from these Phase III Clinical Trials in the first quarter of 2007, followed by submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Dr. Gerald Yakatan, Cobalis' CEO, said, "I am very pleased with the speed and efficiency with which the patient enrollment was conducted, and I believe it is a reflection of the breadth of the market opportunity we are addressing. I would like to congratulate our clinical team on a job well done. Assuming a favorable trial outcome, we plan to expeditiously prepare and submit the NDA.
These twin studies, consisting of 788 and 763 patients, are anticipated to fulfill the requirement for the two Phase III double blind, placebo controlled studies typically required for FDA approval.
Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com
It is expected that the ten-week trials will be completed in November. Cobalis expects to report final data from these Phase III Clinical Trials in the first quarter of 2007, followed by submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Dr. Gerald Yakatan, Cobalis' CEO, said, "I am very pleased with the speed and efficiency with which the patient enrollment was conducted, and I believe it is a reflection of the breadth of the market opportunity we are addressing. I would like to congratulate our clinical team on a job well done. Assuming a favorable trial outcome, we plan to expeditiously prepare and submit the NDA.
These twin studies, consisting of 788 and 763 patients, are anticipated to fulfill the requirement for the two Phase III double blind, placebo controlled studies typically required for FDA approval.
Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com
posted by Madison @ 11:44 AM
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