Precision Therapeutics and Med BioGene Partner to Commercialize LungExpress Dx
March 01, 2011

PITTSBURGH, PA and VANCOUVER, BC — Precision Therapeutics, Inc. and Med BioGene Inc. (TSXV: MBI) today announced a commercialization, license and research reimbursement agreement that provides Precision with exclusive global rights to develop and commercialize 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 is expected to provide better-informed and personalized treatment decisions to assist in the selection of patients for adjuvant chemotherapy.

“This agreement to commercialize LungExpress Dx underscores Precision’s ongoing commitment to improve the outcomes of cancer patients by providing personalized medicine solutions that aim to increase quality of life and cancer survival rates,? said Sean McDonald, Precision’s President and Chief Executive Officer. “LungExpress Dx will be a synergistic and important addition to ChemoFx®, our flagship test.  LungExpressDx identifies early stage patients who have a poor prognosis and may benefit from chemotherapy and ChemoFx® quantifies an individual patient's probable tumor response to various chemotherapeutic and biologic agents.?

“Given Precision’s long-established leadership in the personalized medicine market generally, and lung cancer specifically, we believe that they are ideally positioned to advance LungExpress Dx,? said Erinn Broshko, Chief Executive Officer of MBI. “We have undertaken a thorough strategic review process and, in selecting Precision as our commercial partner, believe that this collaboration will provide increasing and significant value to MBI shareholders as Precision executes on its commercial strategy.  Importantly, we are moving closer to providing NSCLC patients and doctors with an important tool to address a critical unmet need.?

Under terms of the agreement, Precision will pay to MBI within 120 days of closing license fees and research reimbursement of US$1.6 million. In addition, MBI is eligible to receive up to US$1.0 million in payments based on achievement of certain milestones associated with the development and commercialization of LungExpress Dx.  Also, MBI will receive royalty payments based on a market percentage rate of Precision’s future revenues associated with the commercialization of LungExpress Dx or any other products incorporating MBI’s technology.  Precision will also cover certain expenses of MBI incurred in relation to the proposed transaction.

Precision will be responsible for all future costs associated with the development and commercialization of LungExpress Dx and the parties may undertake co-marketing arrangements involving LungExpress Dx.

The closing of the agreement is subject to customary conditions and includes approval of the transaction by the MBI shareholders at a special meeting to be announced, receipt of certain assurances from the University Health Network and MBI settling its outstanding debt with creditors

About Early-Stage Non-Small-Cell Lung Cancer and LungExpress Dx

Early-stage NSCLC patients are treated primarily by surgical removal of their tumors.  Recent clinical trials have established that adjuvant chemotherapy, administered after tumor removal, significantly improves the survival of stage II patients, but does not significantly improve the survival of stage I patients.  As a result, the American Society of Clinical Oncology and National Comprehensive Cancer Network recommend adjuvant chemotherapy for stage II patients but not for stage I patients.

Thirty to fifty-five percent of stage I and II patients die as a result of their disease, implying that patients diagnosed within the same stage of disease can have markedly different treatment responses and survival rates.  Currently, tumor stage (determined by the size and location of the tumor and lymph node involvement) remains the strongest predictor of survival, but it fails to account for this difference in patient outcomes.  LungExpress Dx is expected to help address this critical issue.

As published in the Journal of Clinical Oncology, the fifteen-gene signature of LungExpress Dx was developed using five-year outcome data from untreated early-stage NSCLC patients from the National Cancer Institute of Canada Clinical Trials Group JBR.10 trial. In this study, 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 being developed in collaboration with a team of internationally acclaimed researchers and physicians at Princess Margaret Hospital in Toronto.  The team is led by Dr. Frances A. Shepherd, holder of the Scott Taylor Chair in Lung Cancer Research and the Past-Chair of the National Cancer Institute of Canada Clinical Trials Group Lung Cancer Site, and Dr. Ming-Sound Tsao, holder of the M. Qasim Choksi Chair in Lung Cancer Translational Research.  Drs. Shepherd and Tsao are Professors at the University of Toronto and have in total authored more than 500 articles in peer reviewed journals.

Princess Margaret Hospital, a research hospital of the University of Toronto, has achieved an international reputation as a global leader in the fight against cancer and is considered one of the top comprehensive cancer treatment and research centers in the world. Princess Margaret Hospital, together with its research institute, the Ontario Cancer Institute, is a member of the University Health Network, which also includes the Toronto General Hospital and the Toronto Western Hospital.  Princess Margaret Hospital is the only facility in Canada devoted exclusively to cancer research, treatment and education.

About Precision Therapeutics

Precision Therapeutics, a life-science company based in Pittsburgh, Pennsylvania, is committed to improving outcomes of cancer patients.  As leaders in the science of individualizing cancer therapy through the use of a proprietary and unique platform, Precision develops novel markers to help guide treatment decisions based on the biological processes of each individual’s cancer.

Precision’s state of the art bioinformatics combined with the analysis of the functional molecular, genomic and proteomic activity of each patient’s cancer offer an innovative foundation for further development and commercialization of novel predictive markers for cancer therapy. Precision’s first commercial test, ChemoFx® is a proprietary drug response marker which measures an individual’s functional tumor response to a range of standard therapeutic alternatives under consideration by a physician.

Precision Therapeutics is a private, venture capital-backed company and has received financing from Adams Capital Management, Bain Capital Ventures, Longitude Capital, and Quaker BioVentures, among others. For more information, please visit www.precisiontherapeutics.com.

About Med BioGene

MBI, a life-science company based in Vancouver, British Columbia, is focused on the development and commercialization of genomic-based personalized clinical laboratory diagnostic tests.  MBI is committed to advancing personalized medicine by commercializing tests that provide clinically relevant information to improve patient treatment and reduce health care costs.  MBI’s common shares are traded on the TSX Venture Exchange.  For more information, please visit www.medbiogene.com.

Further Information

For information regarding Precision, please contact:

Bobbi Coffin
Director of Marketing
(412) 432-1593
bcoffin@ptilabs.com

For information regarding MBI, please contact:

Erinn B. Broshko
Chief Executive Officer
(604) 827-5100
ebroshko@medbiogene.com

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

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, 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.

The closing of the agreement is subject to certain conditions and includes approval of the transaction by the MBI shareholders at a special meeting to be announced, receipt of certain assurances from the University Health Network and MBI settling its outstanding debt with creditors.  Such conditions may not be satisfied and the agreement may not close.

LungExpress Dx is MBI’s trademark. ChemoFx is Precision’s registered trademark.  Each trademark, trade name or service mark of any other entity appearing in this news release belongs to its holder.


 

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