CTI BioPharma Announces Topline Data from Final Analysis of the PRE-VENT Clinical Trial Evaluating Pacritinib as a Treatment for Severe COVID-19
The final PRE-VENT analysis was conducted following the randomization of 200 patients. In patients with severe COVID-19 treated with pacritinib/standard of care, compared to placebo/standard of care, a statistically significant improvement in the primary endpoint of progression to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or death by Day 28 was not demonstrated (26.3% vs. 24.8% [OR: 1.01 (95% CI: 0.51-1.99)], P=0.98).
Pacritinib was generally well-tolerated by patients with severe COVID-19, with lower rates of grade 3+ events and serious adverse events being reported in patients treated with pacritinib/standard of care compared to placebo/standard of care (29.2% vs. 40.6% and 20.8% vs. 32.7%, respectively). The most common adverse events comparing pacritinib/standard of care to placebo/standard of care were increased alanine aminotransferase (15.6% vs. 16.8%), anemia (12.5% vs. 17.8%), bradycardia (15.6% vs. 10.9%), constipation (12.5% vs. 12.9%), hypokalemia (12.5% vs. 12.9%), and hyperkalemia (9.4% vs. 10.9%).
"Last year, we launched the PRE-VENT study of pacritinib in patients with severe COVID-19 in response to the pandemic and an unprecedented medical need to improve outcomes for these patients," said
The Company expects to publish a full report on the study in a medical journal.
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R, but not JAK1. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia, and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT.
We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on developing and commercializing pacritinib, our product candidate currently in active late-stage development. We are headquartered in
Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of our PACIFICA Phase 3 trial; the risk that pacritinib may fail in its development through our PACIFICA trials; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
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