BIIB is currently enrolling patients in a global Phase 3 study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population. BIIB plans to enroll more than 1,200 patients in the Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year.
On 7/8/09, Peplin (ASX:PLI) announced the completion of enrolment of its two Phase 3 clinical trials for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on head treatment areas, which include the face and scalp. These Phase 3 clinical trials are referred to as REGION-IIa and REGION-IIb and enrolled approximately 250 patients each. Peplin plans to announce the REGION-II trial results during 4Q09. In addition to the REGION-II trials on head locations, Peplin recently completed its REGION-Ia trial for non-head locations, which included the trunk and extremities, and plans to initiate the REGION-Ib trial during 3Q09 to corroborate the results of the previously completed trial and expects to file a New Drug Application in mid-2010.
On 7/8/09, Transdel Pharma (OTC:TDLP) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.
On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.
