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Tuesday, May 30, 2023

CTI BioPharma Corp. (CTIC) Stock Trends Lower Following Failure of PRE-VENT Trial to Meet Primary Endpoint

CTI BioPharma Corp. (CTIC) stock prices were down by 3.32% shortly after market trading commenced on October 4th, 2021. This brought the price per share down to USD$2.76 early on in the trading day.

CTIC Stock’s PRE-VENT Trial

October 1st 2021 saw CTIC stock announced topline results from its PRE-VENT clinical trial of pacritinib. The treatment is a randomized, double blind, placebo controlled multicenter study. It is designed to compare pacritinib/standard of care verses placebo/standard of care in hospitalized patients. These patients are hospitalized for severe Covid-19, and may or may not have cancer. The primary endpoint of the trial was the proportion of patients who progressed to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or death by day 28. The study was recently amended to a Phase 2 design due to the availability of Covid-19 vaccines and an evolving Covid-19 environment.

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Details of the Trial

A final PRE-VENT analysis was conducted after 200 patients were randomized. A statistically significant improvement in the primary endpoint of progression to invasive mechanical ventilation and/or extracorporeal membrane oxygenation of death by 28 was not observed.  The 200 patients were randomized to receive either pacritinib/standard of care or placebo/standard of care.

Pacritinib Well Tolerated

The treatment was generally well tolerated by patients with severe Covid-19. Patients treated with pacritinib/standard of care reported lower rates of grade 3+ events and serious adverse events than in patients receiving placebo/standard of care. The most common adverse events between the two demographic were increases alanine aminotransferase vs anemia, bradycardia, constipation, hypokalemia, and hyperkalemia.

CTIC Stock Trials Failure

Fiscal 2020 saw CTIC stock launch its PRE-VENT study of pacritinib in patients with severe Covid-19. This was a response to the burgeoning coronavirus pandemic proliferating the globe, resulting in an unprecedented medical need to improve outcomes for affected patients. Despite being well tolerated in the study, the company’s proprietary treatment did not demonstrate a clinical benefit in treating the sickest patients affected by Covid-19. Further development of the treatment will not be pursued further.

Future Outlook for CTIC Stock

The company reported a promising quarter, the momentum of which has been adversely impacted by its most recent PRE-VENT trial results. CTIC stock is poised to recover and re-strategize its approach moving forward in light of this development. Current and potential investors are confident in management’s ability to leverage the resources at their disposal. This is hoped to usher in consistent and organic growth in shareholder value over the long term.

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