Processa Pharmaceuticals Announces First Patient Dosed in its Randomized Double-Blind, Placebo-Controlled Clinical Trial to E...
20 Maggio 2021 - 10:05PM
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 needs, today announced it has dosed
its first patient in the Processa trial to evaluate PCS499 in
treating ulcerations in patients who have Necrobiosis Lipoidica
(NL). NL is a rare, chronic, idiopathic, granulomatous disease of
collagen degeneration caused by a number of very diverse
pathophysiological changes in a patient. In approximately 30% of NL
patients, an open ulcer forms that can have a significant impact on
a patient’s quality of life.
Sian Bigora, Pharm.D., Chief Development Officer
said “The incidence of ulcer closure as assessed by skin
examination in patients treated with PCS499 as compared to placebo
will be a true indication of what PCS499 can do for patients who
currently have no treatment options available for the disease. We
are excited to have randomized the first patient in this Phase 2B
trial.”
The Principal Investigator for the trial is Dr.
Misha Rosenbach. The present site Principal Investigators are Dr.
Misha Rosenbach, Dr. Adeel Ahmad, Dr. Afsaneh Alavi, Dr. Walter
Nahm and Dr. Todd Schlesinger. The first patient was dosed by Dr.
Schlesinger at the Clinical Research Center of the Carolinas.
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 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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