Clinical-stage pharmaceutical company Processa Therapeutics (NASDAQ:PCSA) — which specializes in the field of oncology — is skyrocketing on Thursday. PCSA stock is up about 90% as of this writing, although shares climbed more than 150% at one point today. Undergirding sentiment are encouraging safety results regarding Processa’s anti-cancer therapeutic. The company has also gotten the regulatory green light to move into a Phase 2 trial for its breast cancer treatment.
According to a press release, Processa has successfully completed a safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine (NGC-Cap). Per Morningstar, NGC-Cap combines a proprietary enzyme inhibitor called PCS6422 with the common chemotherapy capecitabine, which represents a treatment for different types of cancer.
Moving forward, Processa has selected two dosage regimens for its upcoming Phase 2 trial, which will target advanced or metastatic breast cancer. Notably, the U.S. Food and Drug Administration (FDA) has agreed to the Phase 1b data being “used to support the design of the Phase 2 trial in breast cancer.”
Scientifically, the biggest takeaway from the trial seems to be the dosing regimen magnitude. Coming in at two to 10 times greater than that of FDA-approved capecitabine, the trial participants received a considerable amount of drug delivery. Yet of the 18 total patients that received the NGC-Cap treatment, two dropped out due to disease progression and only one experienced a mild case of hand-foot syndrome (HFS).
Promising Data Bolsters PCSA Stock
Adding to the enthusiasm for PCSA stock, the variance of incidences of myelosuppression — or decreased bone marrow activity resulting in reduced blood-cell production — warrants some optimism. Specifically, the press release noted the following about the study results:
- Among patients receiving the highest dose of NGC-Cap, 71% experienced some myelosuppression, comparing favorably to the 80% rate reported for “garden variety” capecitabine.
- Further, 57% of participants experienced a more severe form of myelosuppression, higher than the 3% reported for capecitabine. However, this result isn’t necessarily surprising given the much higher dosage regimen.
- At the lower dosage of NGC-Cap, 33% of patients experienced some myelosuppression, lower than capecitabine.
Essentially, part of what’s moving the needle for PCSA stock is that the higher dosage of NGC-Cap carried a similar risk profile to standard capecitabine in exchange for a higher risk of severe forms of myelosuppression. By targeting the optimal dose of NGC-Cap for each patient, Processa can potentially find the most effective risk-reward balance.
With Processa’s experience in defining Optimal Dosage Regimens for FDA approvals, it may have a leg up in the personalized therapeutics ecosystem.
According to Grand View Research, the global personalized medicine market reached a valuation of $538.93 billion in 2022. Further, the sector could expand at a compound annual growth rate (CAGR) of 7.2% to 2030, implying sector revenue of $922.72 billion at the culmination of the forecast.
Why It Matters
Within the past three months, only one analyst — Maxim Group’s Naz Rahman — has coverage of PCSA stock with a “hold” rating and no price target. Extend out to the past 12 months, however, and two other analysts have given shares buy ratings with $3 and $4 price targets.
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On the date of publication, Josh Enomoto did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
