Concordia Healthcare Corp. initiates Phase 3 bile duct cancer trial using photodynamic therapy with PHOTOFRIN®
Thomas Jefferson University Hospital is first site opened, more sites
scheduled in August
TORONTO AND CHICAGO, Aug. 5, 2014 /PRNewswire/ – Concordia Healthcare Corp. (“Concordia”) (TSX: CXR) (OTCQX: CHEHF), a diverse healthcare company
focused on legacy pharmaceutical products, orphan drugs, and medical
devices for the diabetic population, and its subsidiary Pinnacle Biologics, Inc., a biopharmaceutical research and development company specializing in
rare diseases, today announced the initiation of a randomized Phase 3 clinical trial to treat a rare form of bile duct cancer for which there currently is
no acceptable therapy.
The trial will study the efficacy and safety of photodynamic therapy
(PDT) with PHOTOFRIN(®) (porfimer sodium) for injection as treatment for unresectable advanced
perihilar cholangiocarcinoma (CCA) Bismuth type III/IV.
“The fast pace at which we have advanced this trial, from FDA approval
to investigator training to site initiation, is an indication to us of
the medical community’s support and need for new treatments like PDT
therapy with PHOTOFRIN(®),” said Mark Thompson, Chief Executive Officer of Concordia Healthcare
In January, Concordia announced an agreement with the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) to
enroll patients in this pivotal Phase 3, multicenter clinical trial
using PHOTOFRIN(®). The global trial will enroll 200 patients from the U.S., Switzerland,
Germany, South Korea and Canada. Thomas Jefferson University Hospital
in Philadelphia is the first site approved to enroll patients.
Concordia expects more sites to be operational over the next few weeks.
Dr. David E. Loren, Associate Director of Endoscopy and Co-Director of
the Pancreaticobiliary Section, will lead the trial at Thomas Jefferson
“The approved treatment options for patients with bile duct cancer,
known as cholangiocarcinoma, are inadequate and only prolong life by a
few months. Previous studies have shown promise for photodynamic
therapy with PHOTOFRIN(®) in prolonging life more than a year for those affected by this terrible
cancer. We are hopeful that this trial will provide the results needed
to approve the use of this treatment for use in cholangiocarcinoma,”
said Dr. Loren.
PHOTOFRIN(®) has received an FDA orphan drug designation (ODD) to treat CCA, a rare
disease; perihilar CCA represents a very small subset of CCA, with only
about 2,000-3,000 new cases diagnosed annually in the United States.
PHOTOFRIN(®) is indicated for the treatment of esophageal cancer, non-small-cell
lung cancer and high-grade dysplasia in Barrett’s esophagus. PHOTOFRIN(®) was granted orphan drug designation (ODD) by the FDA in 2004 for
cholangiocarcinoma (CCA), a rare cancer in the bile ducts that carry
bile from the liver to the small intestine, and in December 2011, the
FDA granted a second ODD for PHOTOFRIN(®) as adjuvant therapy to surgery for the treatment of malignant pleural
For additional information about PHOTOFRIN(®), please see full prescribing information available at www.PHOTOFRIN.com.
Concordia is a diverse healthcare company focused on legacy
pharmaceutical products, orphan drugs, and medical devices for the
diabetic population. The company’s pharmaceutical business consists of
ADHD-treatment Kapvay(®) (clonidine extended release tablets), Head Lice Treatment Ulesfia(®) (benzyl alcohol) Lotion, Asthma-related medication Orapred ODT(®) (prednisolone sodium phosphate orally disintegrating tablets) and Irritable Bowel Syndrome treatment Donnatal(®) (belladonna alkaloids, phenobarbital). Concordia’s Specialty Healthcare Distribution (SHD) division, Complete
Medical Homecare, distributes medical supplies targeting diabetes and
related conditions. Concordia’s orphan division, Pinnacle, markets
PHOTOFRIN(®) in the United States.
Concordia operates out of facilities in Oakville, Ontario; Lenexa,
Kansas (near Kansas City, Missouri); Chicago, Illinois; Bridgetown,
Barbados; and Charlottesville, Virginia.
Notice regarding forward-looking statements:
This release includes forward-looking statements regarding Concordia and
its business, which may include, but is not limited to, statements with
respect to the addition of new sites approved to enroll patients into
the clinical trial, the ability to obtain necessary approvals, the
approval and development of PDT with PHOTOFRIN® as a new treatment for
certain forms of cancer, the ability of PDT with PHOTOFRIN® to combat
certain forms of cancer, the ability of PDT with PHOTOFRIN® to prolong
the life of anyone affected by certain forms of cancer, medical
community support and requirements for new treatments such as PDT with
PHOTOFRIN® and other factors. Often, but not always, forward-looking
statements can be identified by the use of words such as “plans”, “is
expected”, “expects”, “scheduled”, “intends”, “contemplates”,
“anticipates”, “believes”, “proposes” or variations (including negative
and grammatical variations) of such words and phrases, or state that
certain actions, events or results “may”, “could”, “would”, “might” or
“will” be taken, occur or be achieved. Such statements are based on the
current expectations of Concordia’s management, and are based on
assumptions and subject to risks and uncertainties. Although
Concordia’s management believes that the assumptions underlying these
statements are reasonable, they may prove to be incorrect. The
forward-looking events and circumstances discussed in this release may
not occur by certain specified dates or at all and could differ
materially as a result of known and unknown risk factors and
uncertainties affecting the company, including risks regarding the
pharmaceutical industry, the failure to obtain regulatory approvals,
risks regarding patient enrollment into clinical trials, risks relating
to the use of Concordia’s products to treat certain diseases, economic
factors, market conditions, the equity markets generally, risks
associated with growth and competition and many other factors beyond
the control of Concordia. Although Concordia has attempted to identify
important factors that could cause actual actions, events or results to
differ materially from those described in forward-looking statements,
there may be other factors that cause actions, events or results to
differ from those anticipated, estimated or intended. No
forward-looking statement can be guaranteed. Except as required by
applicable securities laws, forward-looking statements speak only as of
the date on which they are made and Concordia undertakes no obligation
to publicly update or revise any forward-looking statement, whether as
a result of new information, future events, or otherwise.
SOURCE Concordia Healthcare Corp.