NEW YORK, Feb. 9, 2017 /PRNewswire/ -- AAVP Biosystems, Inc. (AAVP), a developmental stage targeted gene therapy company focused on the pursuit of a new therapy for cancer indications, is pleased to announce the hire of Mark Shapiro, M.D., Ph.D., as Chief Medical Officer. Dr. Shapiro joins the team at an important time in the company's development, and will be instrumental in the company's pursuit of an IND and the running of its first Phase I clinical study. The company is preparing to submit its IND application in 2017, and initiate its first in-human Phase I clinical study in 2018.
Dr. Shapiro was previously the Global Medical Affairs Lead for Hematology Programs at Pfizer Oncology. He began his biopharmaceutical career at Genetics Institute (which later became Wyeth and subsequently Pfizer) in 1997, during which time he played an instrumental role in the development of Pfizer's Hematology and previously Wyeth's Oncology portfolio, including Mylotarg, Bosulif, Torisel and inotuzumab ozogamicin, through various leadership roles in Clinical Development and Medical Affairs. Dr. Shapiro has over nineteen years of experience within the pharmaceutical industry with drug development expertise in Hematology, Oncology, Gastroenterology, Immunology/Inflammatory, and Liver Disease areas. Dr. Shapiro holds a B.A. in Mathematics from the University of Chicago, a Ph.D. in Human Genetics from the University of Michigan as well as an M.D. from the University of Cincinnati, at which he was elected to the Alpha Omega Alpha Honor Medical Society. He completed his Internal Medicine house staff training at Columbia-Presbyterian Medical Center (now NY Presbyterian Medical Center – Columbia Campus) in New York City and his Gastroenterology and Liver Disease fellowship training at Albert Einstein College of Medicine in New York City.
Jason Rifkin, President and CEO of AAVP, commented, "We are thrilled to have Dr. Shapiro join our team. He brings with him a track record of successfully bringing cancer drugs through clinical development, and we will rely on his experience and knowledge as we develop our first drug candidate. AAVP is now further positioned to execute its plans, and we look forward to bringing patients a much needed new therapy option."
Commenting on his new role, Dr. Shapiro stated, "AAVP presents a potentially game changing approach to gene and cancer therapy, with its combination targeting technology to deliver a therapeutic gene based payload solely to cancer cells, then acting in a focused manner on these cells. AAVP's current oncology approach under development is the first of many potential applications for this technology, and I look forward to it reaching the clinical trial stage, and ultimately developing additional clinical applications."
About AAVP Biosystems, Inc.
AAVP Biosystems is an early stage biotechnology company developing a targeted gene delivery vector that aims to direct therapy selectively to tumor cells while sparing normal cells and tissue. The core technology is fully and exclusively licensed from MD Anderson Cancer Center, and is undergoing IND-enabling studies in preparation for an IND application. Adeno-associated virus phage or AAVP, is a hybrid vector platform developed by combining the targeting capability of bacteriophage and the sustained gene expression of adeno-associated virus. AAVP has successfully developed a version of bacteriophage that can infect, but not replicate, in specific human cells. That specificity can be tailored to a cell of choice, such as a tumor cell or tumor associated cell. The company's hybrid AAVP can express a gene product in a human cell based on the fact that it carries the gene expression machinery of an adeno-associated virus, but not the adeno-associated virus itself. This avoids the limitations well known to adeno-associated virus including the need for a helper virus and robust immunogenicity limiting clinical efficacy. The result is a platform that can be tailored to target any human cell and express exclusively in that cell, any gene of interest. The company has generated AAVP that infect a variety of cell types and express a variety of gene products, both for therapy and for imaging. AAVP's lead therapeutic, RGD-AAVP-TNF, is designed to selectively infect tumor associated blood vessels and express TNF exclusively in the tumor vascular bed resulting in tumor necrosis. The company has validated this tumor targeting and selective gene expression, as well as therapeutic efficacy and absence of toxicity, in small and large animals. In fact, RGD-AAVP-TNF has been administered in the context of a robust clinical trial in dogs demonstrating safety and anti-tumor activity. AAVP has generated substantial pre-clinical data on stability, dosing and lack of toxicity and is readying to submit an FDA IND filing in preparation for a first in human clinical trial in patients with advanced stage malignancies.
FORWARD LOOKING STATEMENTS - This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained herein, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in this press release, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations. This is not an offer to sell or a solicitation of an offer to buy securities of the company. This press release does not purport to be all-inclusive. You must rely on your own examination of the company.
SOURCE AAVP Biosystems, Inc.