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RenovoRx Appoints Former Chief Medical Officer of Schering-Plough, Robert J. Spiegel, MD, FACP, to Board of Directors
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Very Positive)
Tags
management
Rhea-AI Summary
RenovoRx, a biopharmaceutical company focused on targeted drug delivery for locally advanced pancreatic cancer, announced the appointment of Dr. Robert J. Spiegel to its Board of Directors as of April 25, 2023. With over 40 years in the biopharmaceutical sector, Dr. Spiegel has been instrumental in more than 30 FDA drug approvals, including significant cancer therapies. His leadership is expected to drive discussions with the FDA to expedite progress with RenovoGem™, currently in a Phase III trial for LAPC. RenovoRx's innovative drug delivery platform, RenovoTAMP™, aims to improve treatment outcomes while minimizing side effects. The company holds multiple patents and has received Orphan Drug Designation for its therapies. CEO Shaun Bagai emphasized ongoing trial enrollment and regulatory engagement as part of the company’s growth strategy.
Positive
Appointment of Dr. Robert J. Spiegel brings extensive biopharmaceutical experience, potentially enhancing credibility and strategic direction.
Ongoing discussions with the FDA may expedite the development and approval process for RenovoGem™.
RenovoRx's innovative drug delivery system could signify a breakthrough in treating pancreatic cancer, improving patient outcomes.
Negative
Concerns about continuity and experience gaps with the new board member's integration.
Dependence on regulatory discussions with the FDA may introduce uncertainty in timelines for product advancement.
LOS ALTOS, Calif.--(BUSINESS WIRE)--
RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company focused on targeted drug-delivery with an initial application in locally advanced pancreatic cancer (LAPC), announced today that Robert J. Spiegel, MD, has been appointed to the Company’s Board of Directors, effective April 25, 2023.
Dr. Spiegel brings more than 40 years of biopharmaceutical experience to RenovoRx’s Board. He was involved in more than 30 successful New Drug Application (NDA) approvals by the FDA and the development and launch of multiple products with annual sales exceeding $1B. While at Schering-Plough, he served as Sr. Vice President of Worldwide Clinical Research and Chief Medical Officer. He was involved in the development of numerous cancer drugs and led the development of Remicade® (infliximab), Temodar® (temozolomide), and alpha-interferon (Intron A) through PH I-III studies, securing the first FDA approval for a biologic protein. After Merck acquired Schering-Plough in 2009, Dr. Spiegel became Chief Medical Officer at PTC Therapeutics where he led the company to EU Conditional Approval for the first drug ever approved for Duchene Muscular Dystrophy.
Dr. Spiegel currently serves on numerous publicly listed and privately held boards, including Geron Corporation, Cyclacel Pharmaceuticals, Ayala Pharmaceuticals, Athenex and Sun Pharma Advanced Research Corp (SPARC). He also is an Associate Professor of Medicine at Weill Cornell Medical College, an Advisor to Warburg Pincus and Israel Biotech Fund, and a member of the Leukemia and Lymphoma Society (LLS) TAP committee. Dr. Spiegel completed his Medical Oncology fellowship at the National Cancer Institute and received his MD from the University of Pennsylvania.
“It is a pivotal time in RenovoRx’s evolution, and I am excited to help advance its transformative therapies for patients,” said Dr. Spiegel. “The company’s randomized Phase III interim efficacy and safety data utilizing RenovoGem™ to treat patients with locally advanced pancreatic cancer are very encouraging. The only two FDA approvals in the past decade in pancreatic cancer (Abraxane and Olaparib) showed a sub-2-month improvement in overall survival. Beyond pancreatic cancer, RenovoRx’s drug-delivery platform has a high potential to impact other cancers and possibly indications outside of oncology.”
RenovoRx Chief Executive Officer Shaun Bagai said, “We look forward to Dr. Spiegel’s leadership on our Board as we plan on advancing discussions with the FDA about expediting forward progress with RenovoGem, while continuing our current trial enrollment. Our team is also engaging with worldwide regulatory agencies and identifying new indications and combination products utilizing our therapy platform, RenovoTAMP®.”
About RenovoRx, Inc.
RenovoRx is a late-stage, clinical biopharmaceutical company with a vision to disrupt the current paradigm of biopharmaceutical treatments. Our mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP®) therapy platform aims to avoid the harsh side effects typical of the current standard of care, or systemic delivery methods, thus improving patient well-being and, potentially extension of life, so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and clinical use, with the goal of improving their safety, tolerance, and widening their therapeutic window by providing more targeted delivery at the location of the tumor tissue. RenovoRx’s lead product candidate, RenovoGemTM, is a combination of gemcitabine and its patented delivery system, RenovoCath®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the open label, randomized Phase III TIGeR-PaC clinical trial for the treatment of LAPC.
RenovoRx’s patent portfolio for its therapy platform and product candidates includes eight issued U.S. patents, one issued European patent, and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer (cholangiocarcinoma).
What is the significance of Dr. Robert J. Spiegel's appointment to RenovoRx's Board of Directors?
Dr. Spiegel brings over 40 years of biopharmaceutical experience, which could enhance RenovoRx's strategic direction and credibility in advancing its therapies.
How will Dr. Spiegel impact RenovoGem's development at RenovoRx?
His leadership is expected to facilitate discussions with the FDA, potentially accelerating the progress of RenovoGem, which is in Phase III trials for pancreatic cancer.
What are RenovoRx's main products and their focus?
RenovoRx focuses on targeted drug delivery for cancer treatment, with RenovoGem being its lead product candidate for locally advanced pancreatic cancer.
What are the potential implications of RenovoRx's innovative drug delivery platform?
The RenovoTAMP™ platform aims to improve drug efficacy while minimizing side effects, potentially revolutionizing cancer treatment.
