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

August 11, 2014

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 asbestos(2).

“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.


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
. Industrial Health 45 (3): 379-387. doi:10.2486/indhealth.45.379. PMID 17634686.

SOURCE Concordia Healthcare Corp.

Source: PR Newswire

comments powered by Disqus