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 safety and efficacy for more cancer patients, provides an
interim analysis from its Phase 1b study of its Next Generation
Capecitabine (NGC-Cap).
“These initial data provide our first
confirmatory clinical evidence that NGC-Cap is metabolized
differently than capecitabine and, as a result, may offer
significant improvements in safety and efficacy over capecitabine,
a commonly used chemotherapeutic agent across multiple cancer
indications. We are encouraged to be near completion of the Phase
1b trial as we make preparations for a subsequent Phase 2 trial
with NGC-Cap,” said David Young, Pharm.D., Ph.D., President of
Research and Development at Processa.
Thus far in the Phase 1b study, patients have
received doses of NGC-Cap ranging from 75 mg once a day to 225 mg
twice a day, significantly less than the 1,600 mg to 2,500 mg twice
a day dose administered for FDA-approved capecitabine. More
importantly, these much lower doses for NGC-Cap result in 5-FU
(5-fluorouracil, the main metabolite of capecitabine that further
metabolizes into desirable cancer-killing molecules called
anabolites and undesirable molecules called catabolites that cause
unwanted side effects) exposure up to 10 times greater than the
higher FDA-approved capecitabine doses due to NGC-Cap’s unique
metabolic pathway. One would anticipate that the much greater 5-FU
exposure would result in greater and/or more severe side effects
when, in fact, the side effect profile for 5-FU exposures from
NGC-Cap had a similar anabolite side effect profile to FDA-approved
capecitabine.
In addition, the side effects associated with
FBAL (fluoro-beta-alanine, the primary catabolite formed from the
metabolism of 5-FU), such as hand-foot syndrome, that can lead to
capecitabine intolerance, were almost non-existent, likely because
FBAL exposure was approximately 1% of the exposure seen after
FDA-approved capecitabine administration.
Important to FDA’s request that we evaluate
multiple dosage regimens to determine an Optimal Dosage Regimen,
the interim analysis also shows that an improvement in the side
effect profile was observed at a 5-FU NGC-Cap exposure of 5-6 times
greater than FDA-approved capecitabine.
“We are very encouraged with the interim results
from the Phase 1b trial.” added Dr. Young. “We also appreciate our
recent interactions with FDA and their guidance on the future
development of NGC-Cap, including determining the dosing regimens
that will provide the best safety and efficacy profile for patients
receiving NGC-Cap across many types of cancers. In addition, it is
gratifying to receive confirmation from the FDA on NGC-Cap’s status
as a new chemical entity, which may provide additional commercial
advantages.”
These data confirm that the metabolic pathways
that regulate how NGC-Cap is processed in the body suggest NGC-Cap
may offer higher efficacy at lower doses of the underlying
capecitabine agent, while simultaneously offering a better safety
profile from less production of the side-effect producing
catabolite FBAL that causes many of the dose-limiting side effects
from treatment with capecitabine alone. It is believed that
NGC-Cap’s ability to inhibit the production of catabolites like
FBAL is key to the success of NGC-Cap. Further clinical studies are
needed to confirm these interim observations.
The Company will conduct a Fireside Chat on
December 20, 2023 at 4:30PM ET to discuss these data in further
detail and lay out the Company’s corporate strategy with regard to
the NGC platform. Investors interested in listening may register
early for the event at
https://event.choruscall.com/mediaframe/webcast.html?webcastid=7RISI7Mv.
This link will also connect listeners to the Fireside Chat when it
goes live. Content from the Fireside Chat will be archived through
June 20, 2024.
About Capecitabine Administered with
PCS6422 (NGC-Cap)
NGC-Cap combines the administration of PCS6422,
the Company’s irreversible dihydropyrimidine dehydrogenase (DPD)
enzyme inhibitor, with the administration of low doses of the
commonly used chemotherapy capecitabine.
Capecitabine is the oral form of 5-FU and, along
with 5-FU, is among the most widely used chemotherapy drugs
available, particularly for solid tumors. When metabolized (after
oral ingestion), it becomes 5-FU in the body, which, in turn,
metabolizes to molecules called anabolites that actively kill
duplicating cells, such as cancer cells, and to molecules called
catabolites that only cause side effects. The presence of the DPD
enzyme plays an integral role in the undesirable conversion of 5-FU
to catabolites.
PCS6422 is a uracil analog that irreversibly
inhibits DPD. PCS6422 is neither toxic nor active as a single agent
in animals at comparable dose levels. However, when administered in
combination with capecitabine or 5-FU, PCS6422 decreases the
metabolism of 5-FU to the catabolites that only cause side
effects.
About Processa Pharmaceuticals,
Inc.
Processa is a clinical stage pharmaceutical
company focused on developing the Next Generation Chemotherapy
(NGC) 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
(NGC) drugs following an efficient path to approval. Processa’s NGC
drugs are modifications of existing FDA-approved oncology drugs
resulting in an alteration of the metabolism and/or distribution of
these FDA-approved drugs while maintaining the existing mechanisms
of killing the cancer cells. The company’s 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. The Processa team
has a track record of obtaining over 30 approvals for indications
across almost every division of FDA. Using its proven Regulatory
Science Approach, the Processa Team has experience defining the
Optimal Dosage Regimen using the principles of the FDA’s Project
Optimus Oncology initiative. The advantages of Processa’s NGCs are
expected to include fewer patients experiencing side effects that
lead to dose discontinuation, more significant cancer response and
a greater number of patients -- in excess of 200,000 for each NGC
drug -- who will benefit from each NGC drug. Currently under
development are three next generation chemotherapy oncology
treatments: 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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