ASHBURN, Va., July 28 PA-Innocoll-CollaRx
ASHBURN, Va., July 28 /PRNewswire/ -- Innocoll, Inc., a privately-held
biopharmaceutical company, announced that the third of a series of planned
phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll
Technologies Ltd, to investigate CollaRx(R) 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 peritoneal 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 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 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 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 recognized 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 orthopedic 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 orthopedic surgeries such as hip and knee replacement,
bunionectomy, open fracture repair and certain bone graft procedures.
Dr. Michael Myers, Innocoll's President and CEO 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-centered hysterectomy and
hernia trials later this year, which we believe will underpin the commercial
opportunity this product presents."
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical 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(R) and
Liquicoll(R). 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(R) G, COLLATAMP(R) EG,
SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R),
GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R). 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.
SOURCE Innocoll, Inc.
