Healthcare Industry News: bone graft
News Release - January 4, 2008
Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative PainASHBURN, Va., Jan. 4 (HSMN NewsFeed) -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the first of a series of planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx® BUPIVACAINE SURGICAL IMPLANT for the management of post-operative pain, has commenced dosing.
Innocoll's BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge technology. It is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, abdominal, thoracic, and orthopedic surgeries.
Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including suppression of breathing, sedation, nausea and vomiting, and can also affect patient recovery. Innocoll's BUPIVACAINE SURGICAL IMPLANT is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post- operatively. A key feature of Innocoll's product is the ability to implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneum incision and directly below the skin incision, which enables localized treatment of both the incisional and deep, visceral pain components normally associated with moderate and major surgery. The bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps often used to provide continuous, long-term analgesia at the site of a surgical wound.
Innocoll has recently completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers at Wexham Park Hospital, Slough, UK. The results of this trial were particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on systemic morphine administered by PCA (patient- controlled analgesia). This extended action was achieved despite a low total bupivacaine dose (150mg as the hydrochloride salt), which is well below the allowable daily dose and equivalent to that used by some practitioners for a once-off wound infiltration with bupivacaine solution prior to wound closure.
For the planned series of phase 2 multi-centered, controlled clinical trials to be performed in the US, Innocoll has appointed Premier Research Group, a recognized industry leader in clinical research for acute and chronic pain, to co-ordinate up to five trials in a variety of soft and hard tissue procedures; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and orthopedic surgery. The first of these trials that has commenced dosing will compare the analgesic effect of BUPIVACAINE SURGICAL IMPLANT versus a placebo implant and current standard of care in patients undergoing abdominal hysterectomy at eight different US sites. The other phase 2 soft tissue trials in herniorrhaphy and open gastrointestinal surgeries are expected to commence in early 2008.
About one third of women in the US have a hysterectomy by age 60 and each year, more than 600,000 hysterectomies are performed across the country. Other procedures where the product could potentially be used routinely include caesarean section, inguinal hernia repair, open-heart surgery, mastectomy, open gastrointestinal surgery, cholecystectomy, vascular surgery, and various orthopaedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone graft procedures. Detailed market research performed independently by L.E.K. Consulting has predicted peak US sales of BUPIVACAINE SURGICAL IMPLANT nearing $310 million.
"This first dosing with our Bupivacaine Implant for the management of post-operative pain follows hot on the heels of other phase 2 and phase 3 trials recently initiated with our topically-applied Gentamicin-Collagen sponge for the treatment of infected diabetic foot ulcers and our Gentamicin Surgical Implant for the prevention of surgical site infection. This certainly marks a very exciting time for Innocoll as we embark upon the dosing of patients in three clinical trials for different products spanning three different therapeutic categories", said Dr. Michael Myers, Innocoll's President and CEO.
About Innocoll, Inc.
Innocoll is a privately held, specialty pharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx® and Liquicoll®. Innocoll 's lead product, GENTAMICIN SURGICAL IMPLANT, for the treatment and prevention of surgical site infections, is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL®. In 2005, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP ) and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit www.innocollinc.com.
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