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IMMUNETECH's PENTYDE (PENTIGETIDE) NEEDS ADDITIONAL EFFICACY STUDY

Executive Summary

IMMUNETECH's PENTYDE (PENTIGETIDE) NEEDS ADDITIONAL EFFICACY STUDY to establish the use for allergic rhinitis, FDA's Pulmonary-Allergy Drugs Advisory Committee recommended at its Nov. 19 meeting. "Indication of efficacy has been demonstrated, but not to the criterion of proof required," committee member Gordon Avery, MD, Washington Children's Hospital, commented. "Another study embracing some of the specific points of design [suggested by the committee] would be recommended." Based on its review of two clinical studies in the pentigetide NDA, the committee agreed that while a trend toward demonstrated efficacy existed, a new protocol would help establish the drug's efficacy. The committee suggestions for the new study included: selection of patients with a greater severity of rhinitis; prespecified primary endpoints; equal numbers in drug and placebo groups, a geographic location with a defined pollen season; more datapoints; and more importance given to patient evaluation of symptoms. The pentigetide NDA for the treatment of allergic rhinitis was based on two double-blind randomized placebo-controlled studies involving a 15-day, four-center trial in 138 patients and a six-week, 12-center trial in 529 patients. Pentigetide, a peptide derived from Immunoglobulin E, was given subcutaneously twice a week. The clinical endpoint was suppression of the symptoms of sneezing, nasal congestion and rhinorrhea. The four-center study was conducted in San Diego, California, while the 12-center trial was nationwide, with some sites in California. The committee said the studies were inadequate primarily because of the location, lack of datapoints, and the inclusion of patients with mild allergic rhinitis. "I am not sure that southern California is the best place to do these studies," Harold Nelson, MD, National Jewish Center for Immunology and Respiratory Medicine, said. "I think they should be done in places with much more clear cut and severe pollen seasons," he noted, "and the patients should be selected who are significantly sensitive [to pollen]." FDA reviewer Richard Nicklas, MD, noted that of the four parameters of efficacy studied - global assessment of symptoms by physician and patient, physician rating of frequency and severity of symptoms, and the patient's diary on severity of symptoms - only data from the 12-center study on physician rating of frequency of symptoms was found to be statistically significant.
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