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Innocoll Announces Dosing Of First Patient In US Phase 2 Clinical Trial To Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT
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(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 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(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 http://www.innocollinc.com.
Innocoll Inc.
http://www.innocollinc.com
Innocoll Announces Dozarea de Primã pacient din SUA Faza 2 studiu clinic pentru a investiga CollaRx (R) BUPIVACAINE chirurgicale IMPLANT - Innocoll Announces Dosing Of First Patient In US Phase 2 Clinical Trial To Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT - articole medicale engleza - startsanatate