Med BioGene Inc. (TSX VENTURE:MBI) today provided an update regarding the
commercialization of LungExpress Dx and ongoing litigation with Signal Genetics
LLC and Respira Health LLC.


Commercialization of LungExpress Dx

LungExpress Dx 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
LungExpress Dx 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. LungExpress Dx was subsequently validated in
predicting patient mortality in four independent studies involving data from
tumor specimens totaling 676 untreated early-stage NSCLC patients. LungExpress
Dx is expected to provide better-informed and personalized treatment decisions
to assist in the selection of patients for adjuvant chemotherapy. 


On April 15, 2011, MBI closed its commercialization, license and research
reimbursement agreement (the "Commercialization Agreement") with Precision
Therapeutics, Inc. The Commercialization Agreement provides to Precision
exclusive global rights to develop and commercialize LungExpress Dx. 


LungExpress Dx is currently validated for use with frozen tumour tissue.
Precision is responsible for all costs associated with the development and
commercialization of LungExpress Dx and is commencing clinical studies to
validate the use of LungExpress Dx with tissue preserved by RNARetain, a
molecular fixative. RNARetain eliminates the need to flash-freeze specimens and
to keep specimens frozen throughout storage and transport, a process that can be
cumbersome and costly. 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. 


These clinical studies are being conducted using patient specimens collected
prospectively by Precision from a consortium of medical centers in the United
States. This collection is complete and the final step of validation using
RNARetain has begun. 


Precision expects to commence commercialization of LungExpress Dx in its
CLIA-certified laboratory by mid-2013. In advance of commercialization,
Precision has established an advisory board comprised of world leaders in lung
cancer research and treatment from the United States, Canada, France and Italy.


Sean McDonald, Precision's President and Chief Executive Officer stated: "We are
looking forward to completing our clinical validation studies and improving the
utility and accessibility of LungExpress Dx. We are completely committed to
making this important test available to patients and physicians and to improving
the outcomes of cancer patients by providing personalized medicine solutions." 


Erinn Broshko, Executive Chairman of Med BioGene, commented: "The commercial
success of a molecular diagnostic test depends, in large measure, upon the
extent of its integration into current pathological processes. The use of
LungExpress Dx with RNARetain will allow pathologists to avoid the logistics
involved with using flash-frozen tumor specimens and, instead, to handle and
ship specimens at room temperature, thereby simplifying the process
significantly. We believe that this will materially enhance the commercial
prospects of our test and are encouraged by the progress made by Precision."


Amendment of Commercialization Agreement

Under the terms of the Commercialization Agreement, Precision has paid to MBI
license fees and research reimbursement of $2.3 million, half of which is
credited against future royalties that may be owed to MBI by Precision. In
addition, MBI is eligible to receive up to $1 million in payments based on the
achievement of certain milestones, all of which are credited against future
royalties that may be owed to MBI by Precision. MBI and Precision have amended,
among other things, these milestone payments such that Precision will now pay to
MBI, following the commercial launch of LungExpress Dx, amounts totaling
$500,000 and, following the achievement of $5 million in net revenues from
LungExpress Dx, amounts totaling $500,000. 


MBI will also receive royalty payments in the high single digits based on a
percentage of Precision's future net revenues associated with the
commercialization of LungExpress Dx. 


Erinn Broshko further commented: "By restructuring the milestone payments in our
commercialization agreement, we expect to extend MBI's cash runway following the
commercialization of LungExpress Dx to allow us the opportunity to demonstrate
increasing clinical and commercial success of our test. As a result of our
focused burn rate, we believe that MBI currently has sufficient cash resources
to continue with operations until approximately the first quarter of 2014. If
Precision commercializes LungExpress Dx around the expected timeframe then, with
receipt of the $500,000 in milestone payments from Precision relating to
commercial launch, we believe that MBI will have sufficient cash resources to
fund operations until approximately the third quarter of 2015."


Litigation with Signal Genetics, LLC and Respira Health LLC

In February 2011, Signal Genetics LLC ("Signal") and Respira Health LLC
("Respira") filed a lawsuit against MBI and Precision Therapeutics, Inc. in the
Supreme Court of the State of New York asserting twelve causes of action against
MBI. MBI continues to believe that the lawsuit is frivolous, vexatious and
entirely without merit and is defending the lawsuit vigorously. MBI has received
financial support from Precision to, among other things, conduct such defense
(half of which is credited against future royalties that may be owed to MBI by
Precision) and to cover any settlement or award of damages made against MBI,
subject in all cases to certain threshold limits. 


Discovery in the lawsuit has been completed and, on August 24, 2012, MBI filed a
motion for partial summary judgment to dismiss the claims of Signal and Respira
for lost profits, and causes of action for negligent misrepresentation, unfair
competition and unjust enrichment. The hearing to rule on that motion has not
yet been scheduled.


About Precision Therapeutics

Precision is a leading life science company based in Pittsburgh, Pennsylvania,
and 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 cancer
care continuum. For more information, 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 LungExpress Dx, a
proprietary gene expression-based test for early-stage non-small-cell lung
cancer. LungExpress Dx is expected to provide better-informed and personalized
treatment decisions to assist in the selection of patients for adjuvant
chemotherapy. MBI has partnered with Precision Therapeutics for the global
commercialization of LungExpress Dx. MBI's common shares are traded on the TSX
Venture Exchange. For more information, 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 amended Commercialization
Agreement 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.


Grafico Azioni Med Biogene (TSXV:MBI)
Storico
Da Apr 2024 a Mag 2024 Clicca qui per i Grafici di Med Biogene
Grafico Azioni Med Biogene (TSXV:MBI)
Storico
Da Mag 2023 a Mag 2024 Clicca qui per i Grafici di Med Biogene