On 9/21/09, Provectus Pharma (OTC: PVCT.OB) ($0.96, +1%, above-average volume on 21-Sep) announced that it completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma. The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions.
Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response was allowed at the investigator's discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.
On 9/21/09, Incyte Corp. (NASDAQ: INCY) ($7.97, +9%, above-average volume on 21-Sep) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial.
Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters. Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.
On 9/21/09,
results were presented in Europe by OncoMethylome Sciences (EBR: ONCOB.BR) ($6.60, +10%, above-average volume on 21-Sep) for a blood-based diagnostic test for colorectal cancer (CRC). The researchers collected blood before surgery from 193 patients known to have CRC, as well as from 688 controls undergoing colonoscopy for cancer screening. DNA was extracted from the blood plasma and tested for the presence of DNA methylation of specific genes.
