Processa Pharmaceuticals to Present at the World Orphan Drug Congress USA, July 11-13, 2022
12 Luglio 2022 - 2:30PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the
"Company"), a clinical stage biopharmaceutical company developing
drugs to improve the survival and/or quality of life for patients
who have unmet medical conditions announced today that Dr. David
Young, it’s Chief Executive Officer, will present “Thinking
Regulatory First - Considerations for the Effective Development of
Rare Disease Therapies” at the World Orphan Drug Congress USA 2022
Conference on Wednesday, July 13, 2022 at 3:25 pm EDT.
“The Processa team has successfully developed a
number of drugs over the last 30 years with over 30 FDA approvals,
some in Orphan indications.” Said Dr. David Young, CEO. “For
example, while at Questcor, this team was able to successfully
obtain the FDA approval for an Acthar supplemental New Drug
Application for the treatment of infantile spasms, an ultra-rare
orphan condition. Through our collaboration with the FDA, we were
able to define the clinical studies and regulatory path required to
demonstrate that the benefits of Acthar for the treatment of
infantile spasms outweighed the risks associated with Acthar
treatment, the risks of using Acthar off-label with various
regimens, and the risks associated with the natural progression of
infantile spasms without Acthar treatment."
Although Processa has a pipeline of 5 drugs, 3
of which have FDA Orphan Designation, we are only developing 2 for
the treatment of an orphan indication. PCS499 is being developed
for the treatment of the serious orphan indication, ulcerative
Necrobiosis Lipoidica (“uNL”), and PCS3117 is being developed for
the treatment of pancreatic cancer.
PCS499 is currently in Phase 2B trial given that
some efficacy has already been demonstrated in a proof-of-concept
Phase 2A trial. The enrollment of the interim analysis cohort
within the Phase 2B trial should be completed over the next few
months with the analysis of this interim cohort of patients
occurring in the 1H of 2023. The study is expected to complete
enrollment by the end of 2022. Currently, there are no FDA approved
drugs for uNL or NL and the drugs used off-label do not provide
adequate treatment benefits while having adverse events profiles
that minimize their use.
PCS3117 has an IND in pancreatic cancer and
Phase 2A data demonstrating efficacy in various targeted pancreatic
cancer patients (e.g., treatment naïve patients and patients who
are refractory to existing therapy). Processa is presently
designing the potential development programs and will determine
which has the greatest chance of FDA approval after meeting with
the FDA at the end of 2022. Positioning PCS3117 as 1st, 2nd or 3rd
line therapy will not only be important for approval but also for
commercialization.
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 (GI motility/gastroparesis). The members of
the Processa development team have been involved with more than 30
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 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
Floydmfloyd@processapharma.com301-651-4256
Patrick Lin925-683-3218plin@processapharma.com
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