BioMark Diagnostics Receives Clearance From Health Canada to Commence Clinical Trial With Patented Non-Invasive, Urine-Based ...
21 Setembro 2015 - 9:46PM
BioMark Diagnostics Inc. ("BioMark") (CSE:BUX) (FSE:20B)
(OTCQB:BMKDF) announces receipt of a No Objection Letter from
Health Canada, clearing the way for a clinical trial with the
company's metabolite-based assay using a urine sample to measure
response to treatment for lung cancer.
The trial will specifically look at lung cancer and response to
treatment while the company continues its ongoing Phase III trial
for BioMark's early stage, low cost general screening test which
currently has 200 samples preparing to be analyzed.
The trial will recruit patients with lung cancer who are being
treated with chemotherapeutics with enrollment expected to begin
during the fourth quarter of 2015. Dr. Andrew Maksymiuk,
Medical Oncologist at CancerCare Manitoba and Professor in the
Faculty of Medicine at the University of Manitoba, will be the
principal investigator. In 2014, Dr. Maksymiuk was awarded the
Joan K. Mauer Memorial Quality Assurance Award by the Cancer
Therapy Evaluation Program of the U.S. National Cancer
Institute. Dr. Daniel Sitar, Professor Emeritus in the Faculty
of Medicine at the University of Manitoba, will serve as
co-principal investigator. The trial will be conducted at
CancerCare Manitoba along with the clinical support from the staff
at Saint Boniface Research Centre located in Winnipeg,
Manitoba.
"Lung cancer is North America's most deadly cancer, and the
ability to use clinical biomarkers to assess a patient's response
to chemotherapeutics can be highly effective for quickly developing
and managing a time-sensitive, personalized treatment regime," said
BioMark's President and CEO Rashid Ahmed. "A faster treatment
prognosis allows a doctor to course correct or guide a treatment
plan when time is of the essence. The result would be very
beneficial to a patient, medical community and the paying
institutions."
"Our patented assay, which uses a urine sample, can be easily
adopted into routine clinical practice," added Mr.
Ahmed. "This clinical trial is one of several steps we are
taking to bring this technology to physicians and their patients,
and to reinforce BioMark as a life-saving brand. We are honored to
have Drs. Maksymiuk and Sitar leading this clinical trial."
About BioMark's Non-Invasive, Urine-Based
Assay
BioMark's assay consists of screening for the acetylated form of
the drug Amantadine given to patients prior to measurement via LC
MS in body fluids. This acetylation is performed by the enzyme
Spermine/Spermidine N-Acetyl Transferase (SSAT). It has been
documented that elevated levels of SSAT are observed in many
cancers including lung, breast, prostate, melanoma and gastric
cancers. Clinical trials conducted with both cancer and healthy
subjects have provided proof of principle. In addition, analysis of
SSAT mRNA levels in tissue samples allows determination of cancer
type.
About BioMark Diagnostics
Inc.
BioMark Diagnostics is developing proprietary, non-invasive, and
accurate cancer diagnostic solutions, which can help detect,
monitor and assess treatment for cancer early and cost effectively.
The technology can also be used for measuring response to treatment
and potentially for serial monitoring for cancer survivors.
Please visit www.biomarkdiagnostics.com.
Further information about BioMark Diagnostics is available under
its profile on the SEDAR website www.sedar.com, on the CSE website
www.thecse.ca and at www.biomarkdiagnostics.com.
Forward-Looking Information
This press release may include forward-looking information
within the meaning of Canadian securities legislation, concerning
the business of BioMark. Forward-looking information is based
on certain key expectations and assumptions made by the management
of BioMark. Although BioMark believes that the expectations and
assumptions on which such forward-looking information is based are
reasonable, undue reliance should not be placed on the
forward-looking information because BioMark can give no assurance
that they will prove to be correct. Forward-looking statements
contained in this press release are made as of the date of this
press release. BioMark disclaims any intent or obligation to update
publicly any forward-looking information, whether as a result of
new information, future events or results or otherwise, other than
as required by applicable securities laws. We seek safe harbor
The CSE has not reviewed, approved or
disapproved the content of this press release.
CONTACT: Company Contact
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
604-282-6567
info@biomarkdiagnostics.com
Investor Contact
LHA
Jody Cain
310-691-7100
Jcain@lhai.com
BioMark Diagnostics (CSE:BUX)
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