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Recurrent Respiratory Papillomatosis

March 1, 2004

Procyon Biopharma reported additional positive results from an ongoing phase IIa trial investigating PCK3145, a therapeutic peptide for the treatment of metastatic hormone-refractory prostate cancer. Results confirmed Prostate Specific Antigen (PSA) reduction or stabilization in nine subjects and reduction or normalization of plasma Matrix metalloproteinase 9 (MMP-9) in all subjects. The study was designed with four cohorts of four subjects each and was conducted in the U.K. Subjects received 5, 20, 40 and 80 mg/m2 intravenous doses, three times a week for 4 weeks followed by a seven day observation period. The primary objective is the safety and the tolerability of PCK3145, with secondary objectives of efficacy data, tumor response and hormone levels. The company expects to disclose final results study during Q2 2004.

Stressgen reported results from two clinical trials investigating HspE7, an immunotherapeutic product for the treatments of recurrent respiratory papillomatosis (RRP) and anal dysplasia. Results from the phase II RRP study showed high statistical significance in the lengthening the interval between surgeries, its primary endpoint. Data demonstrated that the median of all post-treatment inter-surgical intervals increased 107.6 days compared to 55.3 days at baseline, a 95% increase. The single arm, open label trial enrolled 27 pediatric subjects. Results from the anal dysplasia trial showed the study did not meet its primary end point of measured adjudicated pathological assessment of biopsies. Secondary endpoints of physician's global assessment and a subset of patients with concomitant genital warts reached statistical significance. The study enrolled 133 subjects with anal dysplasia.

November 17, 2003

Stressgen Biotechnologies reported interim results from an ongoing phase II investigating HspE7, a recombinant fusion product for the treatment of recurrent respiratory papillomatosis (RRP). Results showed that the first post-treatment interval increased 78.6% over the pretreatment interval. Data at the study half way point showed the median of all post-treatment inter-surgical intervals compared with pretreatment has increased to 95.9 days, compared to 83.1 days previously reported and 55.3 at baseline. The median interval reported predicts at least 70 fewer surgeries during the first year post- treatment. HspE7 was well tolerated with the most common side effect being mild to moderate reaction at the site of injection. Results were reported at the meeting of the Society of Ear, Nose and Throat Advances in Children held in conjunction with the American Academy of Pediatrics.

September 22, 2003

Stressgen reported positive interim results from a phase II trial investigating HspE7, a recombinant fusion product for the treatment of pediatric recurrent respiratory papillomatosis (RRP). Results showed that the increase in the first post-treatment intersurgical interval and the median of all post-treatment intervals were statistically significant. Overall, the first post-treatment interval increased 78.6% over the pretreatment interval, resulting in fewer surgeries. The primary endpoint evaluated the interval between surgeries following treatment with HspE7 compared to the pretreatment surgical interval. Results were reported at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago.

June 23, 2003

Stressgen reported positive results from a phase II trial investigating HspE7, an immunotherapeutic agent for the treatment of pediatric recurrent respiratory papillomatosis. Results demonstrated that there was a mean increase of 78.6% in the interval between surgeries following treatment with HspE7 compared to the pretreatment surgical interval. Data projects that more than 50 surgeries will be avoided during the year after treatment among all subjects showing a response. The study enrolled 27 subjects, aged 2-18, and treated them a through a subcutaneous injection (500 mcg) administered three times over a 60-day period. Half of the children enrolled in this trial had severe disease defined by a Clinical Score corresponding to severe disease.