Processa Pharmaceuticals Announces Prioritization on Development of Next Generation Chemotherapies
21 Febbraio 2023 - 2:30PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the
“Company”) reiterates the strategic prioritization of its pipeline
of proprietary oncology drugs, defined as Next Generation
Chemotherapies (NGCs). Previous studies with these NGCs suggest
potential improvement in the safety-efficacy profile will
significantly differentiate these NGCs from their three presently
widely used counterparts - capecitabine, gemcitabine, and
irinotecan.
Much of oncology research and drug development
focuses on the search for a new or different way to treat cancer.
Processa’s approach is to modify and improve three different,
widely used chemotherapy treatments with a proven history of
successfully treating many cancer patients but also having a high
rate of non-responders and a significant number of patients who
must decrease the dose or discontinue treatment because of adverse
events. The NGCs have been modified using a proprietary approach
such that they are metabolized and/or distributed differently in
the body than their approved counterpart drugs, while still
maintaining the same mechanism of killing the cancer cells.
Dr. David Young, Processa’s President and CEO
stated, “The Company’s Next Generation Chemotherapy treatments have
the potential to extend the survival and/or quality of life for
more cancer patients than their existing counterpart drugs while
decreasing the number of patients who are required to dose adjust
or discontinue treatment because of adverse events. Based
Processa’s Regulatory Science approach which incorporates the
principles associated with FDA’s Project Optimus Oncology Guidance,
we have already begun to evaluate the safety-efficacy profiles
including the dose-adverse event and dose-efficacy response
relationship. By being able to understand these dose-response
relationships, we should be able to better select dosage regimens
of each Next Generation Chemotherapy treatment that will provide a
better safety-efficacy profile than their widely used marketed
counterpart drugs. Following this approach will not only increase
the likelihood of obtaining FDA approval, but also provide the
evidence that our Next Generation Chemotherapies are safer and more
efficacious than the existing treatments.”
Each of the Company’s pipeline of three NGC
treatments is briefly described:
(1) NGC-Capecitabine is a combination of PCS6422
and capecitabine. PCS6422 alters the metabolism of capecitabine
without having any clinically meaningful biological effect itself.
In clinical trials, NGC-Capecitabine has been shown to be greater
than fifty times more potent with an improved safety profile over
capecitabine. Like capecitabine, NGC-Capecitabine could be used to
treat patients with cancers, such as metastatic colorectal,
gastrointestinal, breast, and pancreatic. We estimate at least
200,000 patients in the United States were diagnosed in 2022 with
metastatic colorectal, gastrointestinal, breast, and pancreatic
cancers. We plan to meet with the FDA in the first half of 2023 to
discuss the Phase 2B design, including the implementation of the
FDA Project Optimus Oncology initiative and the recent Oncology
Guidance as part of the design. We are planning to initiate a Phase
2B trial in the second half of 2023 subject to funding. (2)
NGC-Gemcitabine (PCS3117) is an oral analog of gemcitabine that is
converted to its active metabolite by a different enzyme system
than gemcitabine resulting in a positive response in gemcitabine
patients as well as some gemcitabine treatment-resistant patients.
Like gemcitabine, NGC-Gemcitabine could be used to treat patients
with cancers such as pancreatic, lung, ovarian, and breast. We
estimate at least 275,000 patients in the United States were
diagnosed in 2022 with pancreatic, lung, ovarian, and breast
cancer. We plan to meet with the FDA in 2023 to discuss potential
study designs, including the implementation of the FDA’s Project
Optimus Oncology initiative and the recent Oncology Guidance as
part of the design. The Phase 2B protocol will be submitted to the
existing IND in the second half of 2023 with the initiation of the
trial, subject to funding requirements, occurring soon after the
submission to the IND. (3) NGC-Irinotecan (PCS11T) is a prodrug of
the active metabolite of irinotecan (SN-38). The chemical structure
of PCS11T influences the uptake of NGC-Irinotecan into cancer cells
resulting in more NGC-Irinotecan entering cancer cells than normal
cells in mice. These levels were significantly greater than those
seen with irinotecan, resulting in lower doses of NGC-Irinotecan
having greater efficacy than Irinotecan and improved safety in
animal models. Like irinotecan, NGC-Irinotecan could be used to
treat patients with cancers such as lung, colorectal,
gastrointestinal, and pancreatic cancer. We estimate at least
200,000 patients in the United States were diagnosed in 2022 with
lung, colorectal, gastrointestinal, and pancreatic cancer. We plan
to conduct IND enabling and toxicology studies in 2023 and 2024,
subject to funding.Consistent with the shift in priority, including
the allocation of resources to these NGC drugs, the Company has
begun and will continue to meet with potential licensing partners,
as well as pursue other options to monetize PCS12852 and
PCS499.
About Processa Pharmaceuticals,
Inc.
The mission of Processa is to develop products
with existing clinical evidence of efficacy for patients with unmet
or underserved medical conditions who need treatment options that
improve survival and/or quality of life. The Company uses its
Regulatory Science Approach criteria when selecting and developing
drugs to achieve high-value milestones effectively and efficiently.
Processa will prioritize the three Next Generation Chemotherapy
oncology treatment programs: 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:Michael Floyd(301)
651-4256mfloyd@processapharma.com
Patrick Lin(925) 683-3218plin@processapharma.com
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