Hi Gang,
Can someone please clarify a specific issue I am unclear on. OK Xerecept has been given orphan drug designation by the FDA per the following announcment. Does anyone know if NTII can apply for approval at the conclusion of P2 testing? If so does anyone know if they intend on doing so? Here are excerpts from the old announcment.
Potential Treatment for Patients with Brain Tumors
Richmond, California, April 20, 1998 - Neurobiological Technologies, Inc. (OTC-BB symbol: NTII) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that Xerecept™, the company's synthetic preparation of human Corticotropin-Releasing Factor (CRF), qualifies for orphan drug designation. The company is currently enrolling patients in a randomized, double-blind, positive-controlled Phase II clinical trial to evaluate Xerecept's ability to control neurological symptoms caused by peritumoral brain edema.
Peritumoral brain edema, or swelling in the brain caused by a tumor, is a serious condition affecting approximately 100,000 patients in the U.S. with brain cancer. In these patients, swelling of brain tissue often impairs neurological functioning more than the tumor itself. Symptoms of peritumoral brain edema may include seizures, difficulty in movement, lack of coordination, and impaired mental faculties.
Orphan drug designation provides a company with seven years of market exclusivity after a drug is approved by the FDA for the market, and also makes a company eligible to receive federal monies for clinical research under the Orphan Drug Grant Program. The U.S. Congress enacted the Orphan Drug Act to promote research and development of therapies for rare diseases affecting fewer than 200,000 Americans.
"As a physician, I am pleased that Xerecept has received this designation," said Ronald Goldblum, M.D., vice president of medical affairs at NTI. "These patients are in great need of a safer therapy which will restore neurological function and improve their quality of life. Synthetic corticosteroids, the current standard treatment for this condition, are associated with serious, detrimental side effects at the chronic high doses required for efficacy. These side effects may include muscle wasting, osteoporosis, hyperglycemia, vision problems, and psychosis. In human Phase I clinical trials sponsored by NTI, Xerecept was well tolerated and appeared to be safe in more than 230 courses of treatment."
Abbey Meyers, president and founder of the National Organization for Rare Disorders (NORD), said, "We are pleased that the passage of the Orphan Drug Act, 15 years ago this year, has made it possible to develop important treatments like this one for peritumoral brain edema. The path to the Orphan Drug Act was truly a rocky road, and with promising new treatments like this on the horizon, NORD is thrilled to be able to continue its 15 years of dedicated service in helping patients with rare disorders."
Paul E. Freiman, president and chief executive officer of NTI, said, "We believe that orphan drug designation by the FDA for Xerecept validates our decision to develop the drug for this patient population."
Can someone clear up this issue.
Thanks
Jeffrey
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