MBI Med Biogene Inc

Med BioGene Inc. (TSX VENTURE:MBI) today announced that its commercial partner,
Precision Therapeutics, Inc., presented data regarding GeneFx(R) Lung at the
American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois
and also provided an update on the commercialization of GeneFx Lung.


ASCO Presentation 

The presentation at the ASCO Annual Meeting, titled "Performance of a Prognostic
Genomic Signature for Early-Stage NSCLC in Matched Fresh Frozen and
RNA-Stabilized Tissue," was presented on June 1, 2013. The presented data
detailed the successful completion of the previously announced clinical studies
to validate the use of GeneFx Lung with tissue preserved by RNAlater(R), a
molecular fixative.  


The clinical study was undertaken by Precision Therapeutics of Pittsburgh,
Pennsylvania, Almac Diagnostics Ltd. of Craigavon, Northern Ireland and the
University Health Network and Princess Margaret Hospital of Toronto, Ontario.

With over 30,000 attendees, the ASCO Annual Meeting is one of the largest
educational and scientific events in the oncology community. The five-day event
provides a venue for physicians and scientists to present research results to a
global audience of oncology professionals. 


Sean McDonald, President and Chief Executive Officer of Precision commented:
"The results from our study demonstrate the robustness of GeneFx Lung and
highlight the exceptional work being done by our technicians and partner
clinicians. Only a handful of genomic signatures in other disease areas have
been validated across differing tissue platforms and so we were excited to
present the results from our study." 


RNAlater eliminates the need to flash-freeze specimens and to keep specimens
frozen throughout storage and transport, a process that is cumbersome and costly
and limits test adoption as many laboratories are not equipped to work with
frozen specimens. It also eliminates the need for preserving tissue in formalin,
which is known to cross-link and degrade the nucleic acids rendering them less
suitable for specific downstream molecular applications. 


A copy of the poster from the ASCO presentation will be available on MBI's
website at www.medbiogene.com.


Successful completion of the clinical studies to validate the use of GeneFx Lung
with tissue preserved by RNAlater, and the associated presentation of the data
at the ASCO Annual Meeting, are significant milestones and allows Precision to
move forward with commercialization under CLIA.


Commercialization of GeneFx Lung

Precision plans to commercialize GeneFx Lung under CLIA (Clinical Laboratory
Improvement Amendments of 1988), the United States federal regulations
applicable to clinical laboratory testing. In order to receive a
CLIA-certificate relating to GeneFx Lung to allow for the commencement of
commercial testing, Precision is required to complete certain "wet laboratory
work" and associated data analysis demonstrating the analytical validity of the
assay in Precision's laboratory. Precision has already completed the substantive
analytical design for this work and expects the remaining laboratory work and
data analysis to take approximately 12 to 14 weeks to complete. Precision
anticipates receipt of their CLIA-certification and product launch shortly
thereafter.  


In anticipation of commercialization, Precision is integrating GeneFx Lung into
its sales, marketing and reimbursement teams and will continue with its
successful strategy of having their teams interact directly with surgeons,
oncologists, pathologists and patient advocacy groups to convey the clinical and
health economic benefits of their tests.  


The long-term commercial success of GeneFx Lung will depend largely upon the
extent to which third-party payers reimburse the test. In the United States,
government insurers, such as Medicare and Medicaid, and third party insurers
generally require evidence of both clinical validity (i.e. reliability of test
results associated with the target disease) and clinical utility (i.e. whether
the test results affect actual clinical decision-making) before reimbursing for
a molecular diagnostic test.  


Precision believes that it has sufficient evidence of the clinical validity of
GeneFx Lung from existing and in-process peer-reviewed publications which
demonstrate the prognostic power of the test. In order to establish evidence of
the clinical utility of GeneFx Lung, Precision is planning to initially commence
commercialization of the test through a select group of top-tier clinical and
academic institutions to assess the impact of the GeneFx Lung risk determination
on physician treatment recommendations and patient care decisions. It is
expected that this study will show that GeneFx Lung provides actionable
information which affects the decisions of physicians and will provide to
insurers compelling evidence of clinical utility. Precision is planning to
undertake a broad national commercial roll-out of GeneFx Lung approximately
three to six months from their initial focused launch of the test. The adoption
and recommendation of the use of GeneFx Lung by these centers of excellence and
their key opinion leaders in lung cancer is also expected to increase general
awareness, acceptance and adoption of the test. 


"Reimbursement of GeneFx Lung is critical to ensuring that lung cancer patients
have access to this important technology and we are putting in place a
substantive strategy to provide to public and private insurers clinical data
that will meet their evidentiary requirements. We are successfully applying this
strategy to GeneFx Colon, our gene expression-based test that predicts the risk
of recurrence in patients diagnosed with stage II colon cancer, and are
confident in taking the same approach with GeneFx Lung," noted Sean McDonald.


About GeneFx Lung 

GeneFx Lung is a proprietary gene expression-based test to improve upon staging
for identifying those patients with early-stage non-small-cell lung cancer
(NSCLC) who, following surgical removal of their tumor, are at higher and lower
risks of mortality. In an initial study of patient specimens from the National
Cancer Institute of Canada Clinical Trials Group JBR.10 trial, published in the
Journal of Clinical Oncology, patients classified by GeneFx Lung as higher risk
benefited from adjuvant chemotherapy, and those classified as lower risk did not
benefit and may have experienced a detrimental effect from adjuvant
chemotherapy. GeneFx Lung was subsequently validated in predicting patient
mortality in four independent studies involving data from tumor specimens
totaling 676 untreated early-stage NSCLC patients. GeneFx Lung is expected to
provide better-informed and personalized treatment decisions to assist in the
selection of patients for adjuvant chemotherapy. 


On April 15, 2011, Precision and MBI closed their commercialization, license and
research reimbursement agreement. The agreement provides to Precision exclusive
global rights to develop and commercialize GeneFx Lung.


About Precision Therapeutics 

Precision, a leading life science company based in Pittsburgh, Pennsylvania, is
dedicated to improving the outcomes of cancer patients by providing personalized
medicine solutions that aim to increase quality of life and cancer survival
rates. Precision offers a portfolio of products developed to help guide
physicians and patients with difficult clinical decisions throughout the
continuum of cancer care.  


Precision currently markets a number of tests through its CLIA-certified
laboratory, including ChemoFx(R), BioSpeciFx(R), GeneFx(R) Colon and
miRview(R)mets2.  


For more information on Precision, please visit www.precisiontherapeutics.com. 

About Med BioGene

MBI is a life science company based in Vancouver, British Columbia that is
currently focused on managing the license and rights to GeneFx Lung. MBI's
common shares are listed for trading on the TSX Venture Exchange. 

For more information on MBI, please visit www.medbiogene.com. 

Certain statements in this press release contain forward-looking statements and
information ("forward-looking statements") under applicable United States and
Canadian securities legislation. Words such as "anticipates," "believes,"
"estimates," "expects," "intends," "may," "plans," "projects," "will," "would"
and similar expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying words.
Forward looking statements include, but are not limited to, that with respect to
the timing, completion and/or results of clinical trials or studies, the timing
for commercialization of any products, future profits, future product revenues,
future shareholder value, future operations and plans, the completion and use of
proceeds from transactions or financings and the prospects for negotiating
partnerships or collaborations and their timing. These forward-looking
statements are only a prediction based upon the party's current expectations,
and actual events or results may differ materially. A party may not actually
achieve the plans, intentions or expectations disclosed in its forward-looking
statements. Forward-looking statements are subject to known and unknown risks
and uncertainties and are based on uncertain assumptions that could cause a
party's actual results and the timing of events to differ materially from those
anticipated in such forward-looking information. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date of this press release. A party's forward-looking statements do not reflect
the potential impact of any future partnerships, collaborations, acquisitions,
mergers, dispositions, joint ventures or investments that that party may make.
All forward-looking statements are qualified in their entirety by this
cautionary statement and a party undertakes no obligation to revise or update
any forward-looking statements as a result of new information, future events or
otherwise after the date of this press release, other than as required by
applicable law. Certain information included in this press release in respect of
Precision and its scientific, clinical and/ or commercialization efforts have
been provided to MBI by Precision. MBI may not have been able to confirm the
accuracy of such information and you should not place undue reliance on any such
information, including any information regarding Precision that would constitute
forward-looking information. A redacted copy of the commercialization agreement,
as amended, between Precision and MBI may be found at www.sedar.com. Each
trademark, trade name or service mark of any entity appearing in this news
release belongs to its holder.


FOR FURTHER INFORMATION PLEASE CONTACT: 
Med BioGene Inc.
Erinn B. Broshko
Executive Chairman
(800) 641-3593
ebroshko@medbiogene.com
www.medbiogene.com

Med Biogene (TSXV:MBI)
Historical Stock Chart
From Apr 2024 to May 2024

Med Biogene (TSXV:MBI)
Historical Stock Chart
From May 2023 to May 2024