Processa Pharmaceuticals to Conduct Next Generation Chemotherapy-Capecitabine Phase 2 Trial Based on FDA Guidance and Project Optimus Oncology Initiative
18 Maggio 2023 - 2:00PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the
“Company”) today announces it has received guidance from the U.S.
Food and Drug Administration (“FDA”) regarding the Company’s next
trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”).
The trial for NGC-Cap, the combination of PCS6422 and capecitabine,
will be a Phase 2 safety-efficacy trial in colorectal cancer
patients following the principles of FDA’s Project Optimus Oncology
Initiative, the recent FDA recommendation on how oncology drugs are
to be developed going forward.
David Young, Pharm.D., Ph.D., Processa’s
President and CEO, commented, “Our communications with the FDA have
been extremely productive. One of the most important advantages of
NGC-Cap and all our NGC drugs is that they have been designed to
decrease the side effects associated with the treatment while
increasing the exposure of cancer cells to proven cancer-killing
molecules. These changes are expected to increase the number of
patients who will benefit from each NGC drug given fewer side
effects as well as have a significant impact on a patient’s
response.
“By combining our NGCs and the Processa
Regulatory Science Approach with FDA’s Project Optimus, Processa
can efficiently provide better therapeutic options to cancer
patients while increasing the likelihood of successful marketing
approval. In addition, prior to approval, we expect to show that
there are significant advantages to treating patients with our NGC
drugs over both existing chemotherapy and oncology drugs directed
toward new targets or new mechanisms. We look forward to continued
collaboration with FDA and to providing continued updates to our
shareholders,” concluded Dr. Young.
The Phase 2 trial will be designed to determine
the dose-and exposure-response relationships for both anti-tumor
activity and safety/tolerability by evaluating different dosage
regimens. The final dosage regimens to be used in the Phase 2 trial
will be defined following the determination of the maximum
tolerated dose from the Company’s ongoing Phase 1b trial and in
collaboration with the FDA. To expedite the enrollment of the first
patient, Processa has begun the upfront study preparation tasks,
including protocol preparation for submission to the existing IND
and clinical enrollment planning.
About Processa Pharmaceuticals,
Inc.
Processa is a clinical stage pharmaceutical
company focused on developing Next Generation Chemotherapy (NGC)
drugs intended to improve the safety, tolerability, and efficacy of
cancer treatment. Some of the key advantages of Processa’s NGCs are
expected to be fewer patients experiencing side effects that lead
to dose discontinuation, more significant cancer response, and an
increase in the number of patients who will benefit from each NGC
drug. The 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. By combining the
proven cancer-killing active molecules and the Processa Regulatory
Science Approach with FDA’s new Project Optimus Oncology
Initiative, Processa can provide better therapeutic options to
cancer patients more efficiently while increasing the probability
of FDA approval. Using its Regulatory Science Approach, the
Processa team has consistently demonstrated its ability to obtain
FDA approvals as evidenced by over 30 approvals for indications
across almost every division of the FDA. Our pipeline includes
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, biliary duct, lung, ovarian, breast, and other
cancers), and Next Generation Irinotecan (PCS11T to treat lung,
colorectal, gastrointestinal, pancreatic, and other cancers).
For more information, please 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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