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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?

To: twentyfirstcenturyfox who wrote (14038)	1/16/2006 10:14:09 AM
From: Cal Gary	Read Replies (1) \| Respond to of 14101

Nuvo Research releases positive Pennsaid results 2006-01-16 07:34 ET - News Release Ms. Lynn Riley reports NUVO REPORTS DETAILED PHASE III PENNSAID(R) CLINICAL RESULTS - STATISTICAL SIGNIFICANCE ACHIEVED IN ALL PRIMARY EFFICACY ENDPOINTS Nuvo Research Inc. is releasing detailed positive results of its phase III clinical trial (study 112) of Pennsaid, a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Pennsaid is currently approved for sale in Canada and several European countries. The trial was designed with the advice and recommendations provided by the United States Food and Drug Administration (FDA) to address specific deficiencies identified in the FDA non-approvable letter received by Nuvo in August, 2002. The trial results confirm the efficacy of Pennsaid that has been demonstrated in Nuvo's prior phase III trials. "We are pleased with these robust results and believe they will satisfy the FDA's key efficacy concerns," said Dr. Henrich Guntermann, Nuvo's president and chief executive officer. "We are now working towards our next milestone -- the submission of an amended new drug application (NDA) to the FDA. If approved, Pennsaid will fill a major unmet need in the $6.5-billion osteoarthritis market." Study 112 enrolled 775 patients in the United States and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm, double-blind, 12-week trial applied a topical solution and took an oral pill. The five-arms were: 1) Pennsaid plus oral placebo; 2) topical placebo (containing a small amount of DMSO for blinding purposes) plus oral placebo; 3) topical vehicle control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo; 4) topical placebo plus oral diclofenac; and 5) Pennsaid plus oral diclofenac. Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical end points required by the FDA: pain relief (p equals 0.019), improvement in physical function (p equals 0.046) and improved patient overall health assessment (POHA) (p less than 0.0001). Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3) (pain, p equals 0.009; physical function, p equals 0.026; POHA, p equals 0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid (arm 1) and oral diclofenac (arm 4) for all three end points (p greater than 0.05). Arm 5 was included in the trial at the FDA's request to review the side effect profile of Pennsaid if combined with an oral NSAID. This combination showed no increased incidence of the usual side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone. It is anticipated that the final data from Nuvo's phase III long-term, open-label safety trial (study 112E) will be available in February, 2006. The results of this study will address the safety deficiencies identified in the FDA's non-approvable letter and will form part of the NDA submission in mid-2006. We seek Safe Harbor.