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News

Innocoll commences dosing in Phase 2 clinical trial of pain management surgical implant

Innocoll Technologies : 29 July, 2008  (Company News)
Innocoll has announced that the third of a series of planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, 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. The technology is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynaecological, abdominal, thoracic, and orthopaedic surgeries.

Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavourable 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 peritoneal incision and directly below the skin incision, which enables localised 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 which can be used to provide continuous, long-term analgesia at the site of a surgical wound.

Innocoll has already completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynaecological 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 analgesic 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.

Innocoll has appointed Premier Research Group, a recognised industry leader in clinical research for acute and chronic pain, to co-ordinate up to five US phase 2 multi-centered, controlled clinical trials in a variety of soft and hard tissue procedures; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and orthopaedic surgery. The first of these trials in women undergoing abdominal hysterectomy commenced dosing in December 2007 and the second in men undergoing inguinal hernia repair commenced dosing in March 2008. This third multi-centered trial will compare the analgesic effect of Bupivacaine Surgical Implant versus placebo in patients undergoing open gastrointestinal surgery.

In addition to those surgeries currently being studied, other procedures where the product could potentially be used routinely include caesarean section, mastectomy, cholecystectomy, open heart surgery, vascular surgery, and various orthopaedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone Graft procedures.

Dr Michael Myers, Innocoll's president and chief executive offcier commented 'The dosing of this third phase 2 trial is an important milestone in the development of our Bupivacaine Implant for the management of post-operative pain. Patient enrollment for the first two phase 2 trials is progressing well and we are eagerly anticipating the results of the US multi-centred hysterectomy and hernia trials later this year, which we believe will underpin the commercial opportunity this product presents.'
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