Presage Biosciences Announces First Patient in Clinical Trial of CIVO&#0153 Precision Oncology

SEATTLE, April 19, 2013 /PRNewswire/ --Presage Biosciences, a leader in precision oncology, today announced the initiation of a clinical trial and the first patient use of CIVO, the company's precision oncology platform designed to improve treatment decisions for cancer patients. The single arm, non-therapeutic, observational study, being conducted at Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, is intended to evaluate the feasibility of Presage's CIVO in assessing lymphoma response to multiple microinjected candidate chemotherapy agents.

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"Results from this initial study will assess the potential of CIVO to guide personalized clinical treatment for lymphoma patients," said Richard Klinghoffer, Ph.D., Vice President of Research & Development at Presage Biosciences. "CIVO is designed to enable analysis of the potential therapeutic effect of multiple drugs simultaneously following precise delivery of each agent to a distinct location on the patient's tumor. By employing this technology we hope to discern which drugs induce a localized anti-tumor response, indicative of therapeutic effect, prior to systemic administration of chemotherapy."

The trial will enroll up to 12 patients with either newly diagnosed lymphomas who have not yet received treatment or relapsed lymphoma previously treated with one or more agents in the R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). Patients' lymphomas will be microinjected with up to four drugs comprising rituximab, vincristine, doxorubicin and prednisolone. Twenty-four hours later, the lymph node of interest will be removed and analyzed for target engagement and tissue response.

More information about this study, including additional eligibility criteria and contact information, can be found on clinicaltrials.gov. Study participants are not expected to benefit medically from participation or to directly benefit from the data generated in this feasibility study. None of the data will be released to the patient or treating physician in a manner that could be used to make treatment decisions. Patients may contact Jennifer Lindquist, Patient Care Coordinator / Lymphoma - Intake Office at Seattle Cancer Care Alliance, jlindqui@seattlecca.org or 206-288-6202 for more information.

"When a patient learns they have cancer, they want effective drugs that cause as little toxicity as possible. An expert panel from the American Society for Clinical Oncology found that previous attempts to predict cancer sensitivity to therapeutic agents using cancer cells grown in tissue culture dishes have not helped the way we hoped they would," said Oliver W. Press, M.D., Ph.D., a member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Professor of Medicine at the University of Washington and the Principal Investigator for the study. "Oncologists and patients are eager for a reliable method to assess cancer drug sensitivity or resistance in the patient's own tumor. We look forward to evaluating the Presage's CIVO precision oncology platform and gathering patient data to evaluate the potential of this innovative approach."

About Presage CIVO Precision Oncology
Presage Biosciences' patented CIVO precision oncology platform offers an entirely novel method for simultaneously analyzing multiple cancer drug candidates and drug combinations within a single tumor while that tumor is still in a patient. The technology allows for the precise placement of multiple microdoses of candidate treatments through the skin and directly into a tumor. Such a controlled localization enables drug-specific responses to be measured for an array of drugs or drug combinations. These microdoses also provide the ability to analyze drug effects across the span of a living tumor thus capturing the heterogeneity of cancer cells.

About Presage Biosciences
Presage Biosciences is a leader in precision oncology. In addition to developing the CIVO precision oncology platform, the company is driving discovery of effective drug combinations. We are dedicated to improving cancer drug development so that patients can receive the most effective treatment possible. Presage partners with oncology-focused pharmaceutical companies through strategic alliances to provide previously inaccessible in vivo data to validate novel targets, promote drug candidates to the right indications, and discover effective drug combinations. Presage's CIVO is the world's only known technology to perform simultaneous comparisons of multiple drugs within a living tumor. Presage is privately held and based in Seattle. For more information, visit www.presagebio.com.

The project described was supported by Award Number R42CA144104 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.

SOURCE Presage Biosciences