Processa Pharmaceuticals Doses First Patient in Amended Phase 1B Protocol for PCS6422 Combined with Capecitabine (Next Generation Capecitabine)
20 April 2022 - 10:30PM
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the
“Company”), a clinical-stage biopharmaceutical company developing
products to improve the survival and/or quality of life for
patients who have unmet medical need conditions, announces today
that the first patient with advanced, refractory gastrointestinal
cancer has been dosed in its amended maximum tolerated dose (MTD)
Phase 1B trial for Next Generation Capecitabine (the combination of
PCS6422 and capecitabine) (NCT04861987).
The Company previously reported that a single
dose of PSC6422 in this Phase 1B trial successfully inhibited
dihydropyrimidine dehydrogenase (DPD), resulting in capecitabine
approximately 50 times more potent (per mg of capecitabine
administered) than FDA approved capecitabine, but the improved
potency did not last throughout the seven days of capecitabine
dosing.
Dr. David Young, Chairman and CEO of Processa
said, “Our goal with Next Generation Capecitabine is to provide a
more effective and/or safer therapy for patients with
gastrointestinal cancer and other types of cancer. The revisions to
the original protocol will now provide the data which will not only
allow us to significantly increase the potency of Next Generation
Capecitabine throughout capecitabine dosing but could also lead to
more optimal dosing for each patient through an
individualized-personalized medicine approach. We expect to have
preliminary data on a better Next Generation Capecitabine regimen
by mid-2022 and anticipate that the MTD for Next Generation
Capecitabine will be determined by the end of 2022. We then plan to
move to either a Phase 2B or Phase 3 trial in 2023 based on our
discussions with FDA.”
Next Generation Capecitabine (PCS6422 and
Capecitabine)
Capecitabine is one of the most widely used
chemotherapy agents in oncology and addresses a
multi-billion-dollar market. It is an oral prodrug of 5-FU that
converts to 5-FU. The problem with the current use of
capecitabine is that approximately 80% of 5-FU is metabolized
through catabolism to non-cancer killing metabolites that may cause
dose-limiting side effects such as hand-foot syndrome and
cardiotoxicity while only 20% of 5-FU is metabolized through
successive phosphorylation steps to active nucleotides which kill
cancer cells. Given the catabolism is initialized through the DPD
enzyme, PCS6422 (an irreversible inhibitor of DPD) decreases the
catabolism of 5-FU resulting in more of the 5-FU being metabolized
to active 5-FU nucleotides which may lead to an increase in the
cell death potency for each mg of capecitabine administered. Thus,
combining capecitabine with PCS6422 results in lower amounts of
capecitabine needed to cause cell death, making the
PCS6422-capecitabine combination a more potent and potentially
safer Next Generation Capecitabine.
The Next Generation Capecitabine (PCS6422
administered with capecitabine) Phase 1B trial (NCT04861987) is a
multi-center, maximum tolerated dose trial in patients with
advanced, refractory gastrointestinal cancer. The amended Phase 1B
trial is designed to evaluate the change in the metabolism of 5-FU
when DPD has been inhibited, elucidate de novo formation of DPD in
the presence of 5FU, and given the increased potency of
capecitabine, the MTD of Next Generation Capecitabine. The
metabolism and pharmacokinetics of capecitabine, 5-FU, and their
metabolites are being evaluated as well as the dose-limiting
toxicities and adverse event profile. Preliminary evidence of
efficacy and further confirmation of the safety of Next Generation
Capecitabine will also be obtained when possible.
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 these
criteria for selection to further develop its pipeline programs to
achieve high-value milestones effectively and efficiently. Active
clinical pipeline programs include: PCS6422 (metastatic colorectal
cancer and breast cancer), PCS499 (ulcerative necrobiosis
lipoidica) and PCS12852 (gastroparesis). The members of the
Processa development team have been involved with more than thirty
drug approvals by the FDA (including drug products targeted to
orphan disease conditions) and more than 100 FDA meetings
throughout their careers. For more information, visit the company’s
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 that 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 Floyd301-651-4256mfloyd@processapharmaceuticals.com
Patrick Lin925-683-3218plin@processapharmaceuticals.com
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