University of Mannheim Medical Center is first site opened
TORONTO and CHICAGO, Oct. 7, 2014 /CNW/ - Pinnacle Biologics, Inc. ("Pinnacle"), a subsidiary of Concordia Healthcare Corp., ("Concordia") (TSX: CXR) (OTCQX: CHEHF), announced today the initiation of the pivotal Phase 3 trial (OPUS) in Germany for a rare form of bile duct cancer for which there is currently no acceptable therapy. OPUS is an Open-label, multicenter phase 3 on 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 Study. The primary end point is Overall Survival (OS).
The global trial will enroll 200 patients from the U.S., Switzerland, Germany, South Korea and Canada. The first European site to begin screening patients for purposes of enrollment is the University Medical Center Mannheim, which belongs to the Heidelberg University, Germany. Four more European sites are scheduled to be initiated in the coming weeks. In August, Thomas Jefferson University Hospital in Philadelphia was the first U.S. site approved to enroll patients.
CCA or bile duct cancer is uncommon with only about 2,000–3,000 and 900 new cases of CCA diagnosed annually in the United States and Germany, respectivelyi,ii; perihilar CCA (or Klatskin tumor) is a subset of that disease. Bile duct cancer is more prevalent in Asia and the Middle East, mostly because of a common parasitic infection of the bile ductiii.
"Bile duct cancer is rare and current treatment options are inadequate," said Dr. Sebastian Belle, senior endoscopist and oncologist. "Photodynamic therapy with Photofrin has demonstrated promise as an effective treatment that can prolong life for these very ill patients. We hope the trial will provide important new information to guide development of this targeted cancer therapy for patients with uncommon and difficult-to-treat cancers."
Pinnacle, a biopharmaceutical research and development company specializing in rare diseases, is a subsidiary of Concordia Healthcare Corp., a diverse healthcare company focused on legacy pharmaceutical products, orphan drugs, and medical devices for the diabetic population.
"Concordia has built a strong foundation around Pinnacle's development of PDT therapy with PHOTOFRIN," said Mark Thompson, CEO of Concordia. "Our experienced clinical team combined with calculated investment has enabled us to advance development of this treatment, which, because of its application, has the potential for use among a range of rare and difficult to treat cancers like mesothelioma and bile duct cancer."
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 trial using PHOTOFRIN.
About PDT Therapy with PHOTOFRIN
PDT with PHOTOFRIN is a two-step cancer treatment process. PHOTOFRIN, a photosensitizing drug, is injected into the blood stream of patients where it accumulates in cancer cells. PHOTOFRIN is activated or "turned on" with laser light, which attacks cancer cells in nearby tissue. In addition to attacking cancer cells, PDT appears to shrink or attack tumors in two other waysiv,v,vi,vii. The photosensitizer can damage blood vessels in the tumor, thereby preventing the cancer from receiving necessary nutrients. PDT also may activate the immune system to attack the tumor cells.
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), Irritable Bowel Syndrome treatment Donnatal® (belladonna alkaloids, phenobarbital) and Zonegran® (zonisamide) for treatment of partial seizures in adults with epilepsy. 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 are not limited to, statements with respect to the addition of new sites approved to enroll patients into the clinical trial, the ability 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 acceleration of product development, the ability and/or potential of PDT with PHOTOFRIN® to combat certain forms of cancer, the ability and/or potential 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®, the results and/or success of clinical trials 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 associated with clinical trials (including, without limitation, in respect of 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.
iKey Statistics about Bile Duct Cancer. (2013, October 30). American Cancer Society, Retrieved 9 September 2014 http://www.cancer.org/cancer/bileductcancer/detailedguide/bile-duct-cancer-key-statistics
iiDe Groen PC, Gores GJ, Larusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med 1999; 341 (18): 1368-78.
ivDolmans, D., Fukumura, D., & Jain, R. Photodynamic therapy for cancer. Nature Reviews Cancer 2003; 3(5):380–387. [PubMed Abstract]
vWilson, B. Photodynamic therapy for cancer: principles. Canadian Journal of Gastroenterology 2002; 16(6):393–396. [PubMed Abstract]
viVrouenraets, M., Visser, G., Snow, G., & van Dongen, G. Basic principles, applications in oncology and improved selectivity of photodynamic therapy. Anticancer Research 2003; 23(1B):505–522. [PubMed Abstract]
viiDougherty, T., Gomer, C., Henderson, B., et al. Photodynamic therapy. Journal of the National Cancer Institute 1998; 90(12):889–905. [PubMed Abstract]
SOURCE: Concordia Healthcare Corp.
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