Concordia Healthcare Corp. announces first patients enrolled in Phase 2 clinical trial using Photodynamic Therapy with PHOTOFRIN(R) for patients with mesothelioma

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Aug 11, 2014, 07:00 ET

TORONTO, ON and CHICAGO, IL, Aug. 11, 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, announced today that its subsidiary Pinnacle Biologics, Inc., a biopharmaceutical research and development company specializing in rare diseases, enrolled the first patients in a randomized Phase 2 trial to evaluate Photodynamic Therapy (PDT) with PHOTOFRIN® for patients with epithelioid malignant pleural mesothelioma (MPM).

Mesothelioma is a rare, aggressive and deadly cancer that most often manifests itself in the lining of the lungs and is caused almost exclusively by exposure to asbestos. The study is expected to enroll 102 patients over four years.

The study is being supported by an $8 million grant from the National Cancer Institute and conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania in collaboration with the Roswell Park Cancer Institute.

Approximately 3,000 new cases of mesothelioma are diagnosed each year in the U.S.¹; however numbers are expected to increase worldwide due to past uncontrolled exposures to asbestos².

"Malignant pleural mesothelioma remains a complex and typically incurable disease that requires a multi-modal approach to treatment," said Keith Cengel, MD, PhD, lead study investigator, Associate Professor and Director of Photodynamic Therapy in the Department of Radiation Oncology at the Perelman School of Medicine at the University of Pennsylvania. "To date, unprecedented survival rates have been achieved in these patients by combining surgery with Photofrin-mediated photodynamic therapy. Our current study looks to extend these observations by asking what component of this success is due to PDT and can we further improve our results in the future by understanding how PDT interacts with other cancer therapies. The outcome of this study has the potential to shift clinical treatment paradigms for mesothelioma and other cancers with high rates of local recurrence after surgery."

PDT with PHOTOFRIN® is a two-step, targeted treatment that attacks tumor cells without permanently damaging surrounding tissue. The treatment involves the administration of PHOTOFRIN®, a nontoxic, photosensitizing agent that accumulates in cancer cells followed by the application of laser light to the tumor, which activates the drug and attacks the tumor. In this study, PHOTOFRIN® will be administered to trial participants 24 hours prior to surgery. Patients will then undergo a radical pleurectomy, the removal of the pleura or lining of the lung along with the tumor cells contained within. They will then be randomized to two arms: half will receive PDT intraoperatively via an intense laser inserted in the chest cavity during the surgery, along with post-operative standard chemotherapy; and half will receive only post-operative chemotherapy. PHOTOFRIN® absorbs the light from the laser and produces an active form of oxygen that can attack residual microscopic cancer cells left behind after surgery. Radical pleurectomy may allow mesothelioma patients to keep their lung and may provide better postoperative quality of life and improved survival rates when compared to other common definitive mesothelioma surgeries.

"This trial evaluating the efficacy of PDT therapy with PHOTOFRIN® in mesothelioma will hopefully lead to greater understanding and insight into a rare and deadly form of cancer and hopefully establish a new treatment path for patients for whom few options exist," said Mark Thompson, chief executive officer of Concordia Healthcare Corp.

This work is funded by NIH/NCI grant # P01 087971-11.

About PHOTOFRIN®
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.

About Concordia
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 enrollment of patients into clinical trials, 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 or improve the survival rates and/or quality of life of anyone affected by certain forms of cancer, the outcomes and success of clinical trials, the potential of clinical trials to shift clinical treatment paradigms for certain diseases, the ability of clinical trials to generate a greater understanding and/or insight into certain forms of cancer 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 associated with 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.

¹ National Cancer Institute. Mesothelioma age-adjusted SEER cancer incidence rates, 1980-2008, by race, sex and year of diagnosis. http://seer.cancer.gov/csr/1975_2008/results_merged/sect_17_mesothelioma.pdf (accessed 2011 Nov 17)
² Bianchi, C; Bianchi T (June 2007). "Malignant mesothelioma: global incidence and relationship with asbestos". Industrial Health 45 (3): 379-387. doi:10.2486/indhealth.45.379. PMID 17634686.