CTI BioPharma Announces Publication of Article Highlighting Pacritinib Data from the PAC203 Phase 2 Study in Myelofibrosis in Blood Advances

Rhea-AI Summary

CTI BioPharma Corp. (Nasdaq: CTIC) announced the publication of data from the PAC203 Phase 2 trial of pacritinib in the journal Blood Advances. The article discusses the recommended dose of pacritinib for myelofibrosis patients, revealing that the 200 mg BID dosage showed a favorable benefit-risk profile. This supports the ongoing Phase 3 PACIFICA trial and the company's commitment to pursuing regulatory approval. The trial involved patients previously treated with ruxolitinib, showing promising spleen volume response rates.

Positive

• Publication of PAC203 Phase 2 trial data supports the efficacy of pacritinib.
• 200 mg BID dosage selected for ongoing Phase 3 PACIFICA trial based on favorable results.

Negative

• None.

SEATTLE, Nov. 30, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that an article highlighting pacritinib data was published in Blood Advances. The article, titled "Determining the Recommended Dose of Pacritinib: Results from the PAC203 Phase 2 Dose-Finding Study in Patients with Advanced Myelofibrosis" is available online via this link.

"Having recently announced the start of a rolling NDA submission for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia, a patient population with reduced survival and limited therapeutic options, we continue to be committed to adding to the growing body of evidence underscoring the efficacy and safety profile of pacritinib," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "As our application will consist of a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials, with the ongoing Phase 3 PACIFICA trial expected to be completed as a post-marketing commitment, the data published today support our belief that pacritinib has the potential to become an important treatment in this disease setting, pending regulatory approval."

PAC203 Phase 2 was an open-label, randomized, dose-finding trial of pacritinib in patients with myelofibrosis who were previously treated with ruxolitinib. Patients were randomized 1:1:1 to pacritinib 100 mg daily (QD), 100 mg BID, or 200 mg BID. The trial demonstrated that pacritinib 200 mg BID had a favorable benefit risk profile. Spleen volume response (SVR) rates were highest among patients treated with pacritinib 200 mg BID who had a baseline platelet count of less than 50 x 10⁹/L. Overall, the study data supported the selection of the pacritinib 200 mg BID for use in the ongoing Phase 3 PACIFICA study of pacritinib in patients with myelofibrosis with severe thrombocytopenia.

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. 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 FLT3.

About CTI BioPharma Corp.
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 evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

Forward-Looking Statements
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 successfully demonstrate the safety and efficacy of pacritinib; our ability to complete a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; our planned commercialization of pacritinib; our ability to enter into potential partnerships relating to our commercial launch of pacritinib; 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, 2019 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. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

CTI BioPharma Investor Contacts:
Maeve Conneighton/Maghan Meyers
+212-600-1902
cti@argotpartners.com

 

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SOURCE CTI BioPharma Corp.

FAQ

What were the results of the PAC203 Phase 2 trial for pacritinib?

The PAC203 trial demonstrated that pacritinib 200 mg BID had a favorable benefit-risk profile, particularly for patients with a baseline platelet count of less than 50 x 10⁹/L.

What is the next step for CTI BioPharma regarding pacritinib?

CTI BioPharma is continuing to the ongoing Phase 3 PACIFICA trial following the positive outcomes from the PAC203 trial.

When was the PAC203 Phase 2 trial data published?

The PAC203 Phase 2 trial data was published on November 30, 2020, in the journal Blood Advances.

What does the PAC203 trial data imply for pacritinib's market potential?

The positive trial results enhance pacritinib's potential as a significant treatment option for myelofibrosis patients, pending regulatory approval.