Processa Announces First Patient Dosed in PCS6422 Study in Gastrointestinal Cancer
04 Agosto 2021 - 2:30PM
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), a clinical-stage
biopharmaceutical company developing products to improve the
survival and/or quality of life for patients who have an unmet
medical need condition, announced today it has dosed the first
patient in its Phase 1b Dose-escalation Study of the Safety and
Pharmacokinetics of Fixed-dose PCS6422 With Escalating Doses
of Capecitabine Administered Orally to Patients With Advanced,
Refractory Gastrointestinal Tract Tumors. Detailed information on
the trial can be located at
https://clinicaltrials.gov/ct2/show/NCT04861987
“We believe that the irreversible inhibitor
effects of PCS6422 on the dihydropyrimidine dehydrogenase enzyme
may significantly improve exposure to the cancer killing 5-FU
metabolites while reducing the 5-FU metabolites, like
α-fluoro-β-alanine, related to dose limiting side effects such as
hand foot syndrome. The dosing of the first patient in our Phase 1b
trial represents an important step to explore PCS6422’s potential
as a disease modifying therapy for capecitabine,” said Dr. Sian
Bigora, Chief Development Officer. “By the end of 2021, we expect
to have interim results evaluating the positive effect that PCS6422
has on capecitabine while in 2022 we anticipate being able to
define a new maximum tolerated dose and potential biomarkers for
the PCS6422 - capecitabine combination which will help us to define
the pivotal Phase 3 study design needed for FDA approval.”
Dr. David Young, Chief Executive Officer, added,
“The Processa strategy is to design and develop our pipeline of
drugs to improve a patient’s benefit-risk profile compared to
existing therapy. PCS6422 is a prime example of the drugs in our
pipeline and being able to enroll our first patient into this study
is the first of many steps that we expect to achieve over the next
6-18 months.”
The present site Principal Investigators are Dr.
Jean Grem, Dr. Patrick Boland, Dr. Olivier Rixe, Dr. Sanjay Goel
and Dr. Alexander Spira. The first patient was dosed by Dr. Olivier
Rixe at Quantum Santa Fe.
About Processa
Pharmaceuticals, Inc.
Our mission is to develop drug products that
improve the survival and/or quality of life for patients with high
unmet medical need conditions. We are a development company, not a
discovery company, that seeks to identify and develop drugs for
patients who need better treatment options than presently exist for
their medical condition. To increase the probability of development
success, our pipeline only includes drugs which have previously
demonstrated some efficacy in the targeted population or a drug
with very similar pharmacological properties has been shown to be
effective in the population.
We currently have three drugs in various stages
of clinical development: PCS499 for Ulcerative Necrobiosis in Phase
2B; PCS3117 for metastatic pancreatic cancer and non-small cell
lung cancer in Phase 2B; and PCS6422 for metastatic colorectal
cancer and breast cancer in Phase 1B. The PCS12852 IND for the
treatment of gastroparesis will be submitted in 3Q2021.
Members of the Processa development team
throughout their careers have been involved with more than 30 FDA
drug approvals (including drug products targeted to orphan disease
conditions), more than 100 FDA meetings, and two FDA regulatory
science contracts. 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 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 registration
statement relating to the securities being sold in this offering,
which identifies important risk factors which could cause actual
results to differ from those contained in the forward-looking
statements.
For More Information:Michael
Floydmfloyd@processapharma.com301-651-4256
James CarbonaraHayden IR(646)
755-7412james@haydenir.com
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