PITTSBURGH, PENNSYLVANIA and VANCOUVER, BRITISH COLUMBIA--(Marketwire - Jan. 23, 2013) - Precision Therapeutics, Inc. and Med BioGene Inc. (TSX VENTURE:MBI) today announced that Precision Therapeutics has successfully completed their previously announced clinical studies to validate the use of LungExpress Dx™ with tissue preserved by RNAlater®, a molecular fixative.
RNAlater 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.
The clinical studies were conducted using patient specimens prospectively accrued by Precision from a consortium of medical centers in the United States.
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.
"Precision's efforts in commercializing this important test underscores our ongoing commitment to improving 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. "The successful completion of our clinical studies provides further evidence of the robustness of our test and we are moving closer to providing patients and doctors with a tool to address a critical unmet need."
Erinn Broshko, Executive Chairman of Med BioGene, commented: "We are very pleased with the progress made by Precision and are looking forward to our clinically valuable test being available to lung cancer patients. 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 RNAlater 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."
About 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, Precision and Med BioGene closed their commercialization, license and research reimbursement agreement. The agreement provides to Precision exclusive global rights to develop and commercialize LungExpress Dx.
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 cancer care continuum. For more information, please visit www.precisiontherapeutics.com.
About Med BioGene
Med BioGene is a life science company based in Vancouver, British Columbia that is currently focused on managing the license and rights to LungExpress Dx. Med BioGene's common shares are listed for trading 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 Med BioGene by Precision. Med BioGene 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 Med BioGene 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.
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Contact Information:
Precision Therapeutics, Inc.
Pam Ranallo
Media Contact
(412) 432-1500 ext. 1502
pranallo@ptilabs.com
www.precisiontherapeutics.com
Med BioGene Inc.
Erinn B. Broshko
Executive Chairman
(800) 641-3593
ebroshko@medbiogene.com
www.medbiogene.com