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 Corp.
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 University Hospital.
"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 mesothelioma.
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.