Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the
“Company”), a clinical-stage pharmaceutical company focused on
developing the next generation of chemotherapeutic drugs to improve
the efficacy and safety for patients suffering from cancer,
announces the formation of its Oncology Advisory Board featuring
key opinion leaders from multiple nationally-recognized
institutions.
Processa’s Chief Development and Regulatory
Officer and Processa founder, Sian Bigora, Pharm.D., commented, “As
we continue development of our Next Generation Chemotherapy (NGC)
products, it is important that we rely on the guidance of the most
respected advisors in the field. We are excited about the formation
of our advisory board and grateful to its respected members for
their dedication toward optimizing patient care with new drugs that
are distributed preferentially to cancer cells and metabolized more
efficiently to molecules that have been proven to kill cancer. We
expect that these NGC drugs will improve the treatment of cancer by
improving not only the safety and efficacy in cancer patients, but
they will also allow for more cancer patients to be treated given
the improved safety-efficacy profile.”
Advisory Board members include:
- Philip A. Philip, M.D., Ph.D., Henry Ford Cancer Institute
- Mitesh Borad, M.D., Mayo Clinic
- Patrick Boland, M.D., Rutgers Cancer Institute
- Howard Hochster, M.D., F.A.C.P., Rutgers Cancer Institute
- Sunil Sharma, M.D., F.A.C.P., Translational Genomics (TGen)
Research Institute
Philip A. Philip, M.D., Ph.D., F.R.C.P.,
is Director, Gastrointestinal Oncology, Co-Director,
Pancreatic Cancer Center, Medical Director, Research and Clinical
Care Integration, Henry Ford Cancer Institute, and Professor of
Oncology and Pharmacology, Wayne State University School of
Medicine, Detroit. Dr. Philip is an internationally renowned
medical oncologist specializing in gastrointestinal cancers. He
focuses on new drug development and translational research in GI
and neuroendocrine malignancies with a particular focus in
pancreatic cancer.
His extensive influence in various national and
international arenas includes chairing the GI committee for SWOG
(the NCI-sponsored clinical trials collaborative), serving on the
NCI's Cancer Therapy Evaluation Program committee, authoring more
than 250 publications, co-editing a book on pancreatic cancer, and
serving as an international/national lecturer with more than 400
presentations.
Mitesh Borad, M.D., is
Professor of Medicine, Program Leader for the Gene and Virus
Therapy Program, and Director of the Precision Cancer Therapeutics
Program at Mayo Clinic. He received his M.D. from Rutgers New
Jersey Medical School, completed internal medicine training at
Cedars-Sinai and medical oncology training at Tulane University and
was a Genomics Medicine and Drug Development Scholar at TGen under
the tutelage of Dr. Daniel Von Hoff.
Dr. Borad’s team was the first to demonstrate
anti-tumor activity in FGFR2-fusion cholangiocarcinoma using small
molecule FGFR2 inhibitors and to introduce an oncolytic Rhabdovirus
into human clinical studies.
Patrick M. Boland, M.D., is
Associate Professor of Medical Oncology and Associate Program
Director of GI Medical Oncology within the Department of Medicine
at Rutgers Cancer Institute in New Jersey. Dr. Boland graduated
from Jefferson Medical College (now Sidney Kimmel Medical College)
in 2006. Following completion of his residency at Boston University
Medical Center, he went on to an oncology fellowship at Fox Chase
Cancer Center.
Dr. Boland spent the first several years of his
career at Roswell Park Cancer Institute as a GI oncologist. His
clinical and translational research spans colorectal, anal,
gastroesophageal, and pancreatic cancer, gastrointestinal
malignancies, and neuroendocrine tumors. Dr. Boland has both
developed and conducted multiple clinical trials and is an active
member in the NCI National Clinical Trial Network system, in
addition to multiple other active research consortia.
Howard Hochster, M.D. is the
Associate Cancer Center Director for Clinical Research and
Director, Gastrointestinal (GI) Oncology, at the Rutgers Cancer
Institute and Director of Oncology Research for Robert Wood Johnson
(RWJ) Barnabas, where he directs clinical research. Dr. Hochster
graduated from the Yale School of Medicine. He then worked at NYU
Medical School and Bellevue Hospital where he completed an
internship, residency, and fellowship in Hematology-Oncology. He is
certified in Internal Medicine by the American Board of Internal
Medicine and by the Hematology and Oncology Boards. He then joined
the NYU faculty in medical oncology, rising to full professor
before moving to the Yale Cancer Center where he served as
Associate Director for Clinical Research and head of GI Oncology
until joining Rutgers Cancer Institute.
Dr. Hochster has led numerous clinical trials,
particularly in GI Oncology, and was instrumental in the approval
of eight new drugs for the treatment of colon cancer. He has
authored more than 150 peer-reviewed articles on cancer therapy,
new drug development, and clinical trials. He has been very
involved with the NCI National Clinical Trials Network (NCTN) and
chaired ten Phase 2 and Phase 3 studies in the NCI cooperative
groups. He serves as Deputy Editor for the Journal of the
National Cancer Institute and regularly reviews
manuscripts for Journal of Clinical Oncology, Cancer, British
Medical Journal, and Lancet.
Sunil Sharma, M.D. is the
Physician-In-Chief at TGen Research Institute in addition to Deputy
Director of Clinical Sciences and Professor and Division Director
of Applied Cancer Research and Drug Discovery and Professor of
Medicine at City of Hope. He earned his medical degree at the
University of Delhi in New Delhi, India and his Medical Oncology
fellowship at the University of Texas Health Science Center, San
Antonio, TX.
He has extensive experience in drug development,
including over 200 clinical trials, and has primary interest in
conducting drug discovery and translational research on novel
therapies for cancer. His clinical interests are focused on the
treatment of patients across the gastrointestinal cancer spectrum
(colon, pancreatic, esophageal, gallbladder, liver, stomach, small
intestine, bowel, rectum, and anus).
About Processa Pharmaceuticals,
Inc.
Processa is a clinical stage pharmaceutical
company focused on developing the Next Generation Chemotherapy
drugs to improve the safety and efficacy of cancer treatment. By
combining Processa’s novel oncology pipeline with proven
cancer-killing active molecules and the Processa Regulatory Science
Approach as well as experience in defining Optimal Dosage Regimens
for FDA approvals, Processa not only will be providing better
therapy options to cancer patients but also increase the
probability of FDA approval for its Next Generation Chemotherapy
drugs. Processa’s NGC drugs are modifications of existing
FDA-approved oncology drugs resulting in an alteration of the
metabolism and/or distribution of drugs while maintaining the
existing mechanisms of killing the cancer cells. Our approach to
drug development is based on more than 30 years of drug development
expertise to efficiently design and conduct clinical trials that
demonstrate a positive benefit/risk relationship. Using its proven
Regulatory Science Approach, we have experience defining the
Optimal Dosage Regimen using the principles of the FDA’s Project
Optimus Oncology initiative. The advantages of Processa’s Next
Generation Chemotherapy drugs are expected to include fewer
patients experiencing side effects that lead to dose
discontinuation; more significant cancer response; and a greater
number of patients who will benefit from each Next Generation
Chemotherapy drug. Currently in our pipeline are three Next
Generation Chemotherapy drugs: Next Generation Capecitabine
(PCS6422 and capecitabine to treat metastatic colorectal,
gastrointestinal, breast, pancreatic, and other cancers), Next
Generation Gemcitabine (PCS3117 to treat pancreatic, lung, ovarian,
breast, and other cancers), and Next Generation Irinotecan (PCS11T
to treat lung, colorectal, gastrointestinal, pancreatic, and other
cancers).
For more information, visit our website
at www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking
statements. The statements in this press release that are not
purely historical are forward-looking statements which involve
risks and uncertainties. Actual future performance outcomes and
results may differ materially from those expressed in
forward-looking statements. Please refer to the documents filed by
Processa Pharmaceuticals with the SEC, specifically the most recent
reports on Forms 10-K and 10-Q, which identify important risk
factors which could cause actual results to differ from those
contained in the forward-looking statements.
For More
Information:Investors:Bret ShapiroCORE
IRir@processapharma.com
Company Contact:Patrick Lin(925)
683-3218plin@processapharma.com
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