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Profile: CTI Biopharma Corp (CTIC.A)

CTIC.A on American Stock Exchange

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CTI BioPharma Corp. (CTI), formerly Cell Therapeutics, Inc., incorporated on September 4, 1991, is a biopharmaceutical company focused on the acquisition, development and commercialization of targeted therapies covering a spectrum of blood-related cancers that offer a benefit to patients and healthcare providers. The Company is focused on commercializing PIXUVRI (pixantrone), or PIXUVRI, in the European Union, for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), and conducting a Phase III clinical trial program of pacritinib for the treatment of adult patients with myelofibrosis to support regulatory submission for approval in the United States and Europe. It is also engaged in evaluating pacritinib in earlier clinical trials as treatment for other blood-related cancers.

The Company's earlier-stage product candidate, tosedostat, is an oral, once-daily aminopeptidase inhibitor that has demonstrated responses in patients with acute myeloid leukemia (AML). It is being evaluated in several Phase II cooperative group-sponsored trials and investigator-sponsored trials (ISTs). It is also engaged to evaluate its pipeline candidate paclitaxel poliglumex (Opaxio), which targets solid tumors. It is evaluating this candidate through cooperative group sponsored trials and ISTs, such as the ongoing maintenance therapy trial in patients with ovarian cancer.

PIXUVRI

PIXUVRI is an aza-anthracenedione with structural and physiochemical properties. The European Commission granted conditional marketing authorization in the European Union for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. PIXUVRI is the approved treatment in the European Union for patients with multiply relapsed or refractory aggressive B-cell NHL, who have failed two or three prior lines of therapy. PIXUVRI is available in Austria, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Sweden and the United Kingdom, and has achieved reimbursement decisions under varying conditions in England/Wales, Italy, France, Germany, the Netherlands and Spain. The Company has established a commercial organization, including sales, marketing, supply chain management and reimbursement capabilities, to commercialize PIXUVRI in certain countries in the European Union.

The pivotal Phase III trial, or PIX301, evaluated PIXUVRI for patients with relapsed or refractory aggressive B-cell NHL. The trial enrolled 140 patients randomized to receive either PIXUVRI or another single-agent drug used for the treatment of this patient population and selected by the physician. Approximately 20% of patients in the trial who received PIXUVRI achieved a complete or unconfirmed complete response at end of treatment compared with 5.7% in the comparator group (p=0.021).

Pacritinib

The Company's lead development candidate, pacritinib, is an oral multikinase inhibitor with activity against Janus Kinase 2 (JAK2), and FMS-like tyrosine kinase (FLT3), as well as other kinases, and is being evaluated in adult patients with myelofibrosis. As part of its collaboration with Baxter, the Company is pursuing a approach to advancing pacritinib for adult patients with myelofibrosis by conducting two Phase III clinical trials: one in a set of patients without limitations on blood platelet counts, the PERSIST-1 trial, and the other in patients with low platelet counts, the PERSIST-2 trial. Its PERSIST-1 trial is a multicenter, open-label, randomized, controlled Phase III trial evaluating the efficacy and safety of pacritinib with that of available therapy in patients with thrombocytopenia, or low platelets, and primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. A total of 327 eligible patients were randomized 2:1 to receive either pacritinib 400 milligram (mg) taken orally once daily or the available therapy. The Company's ongoing PERSIST-2 trial is a multi-center, open-label, randomized, controlled Phase III trial evaluating pacritinib in up to 300 patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microlitre. Patients are being randomized (1:1:1) to receive 200 mg pacritinib twice daily, 400 mg pacritinib once daily or available therapy.

Tosedostat

Tosedostat is a selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival. Tosedostat has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase I and II clinical studies. Several ongoing Phase II cooperative group sponsored trials and investigator-sponsored trials (ISTs) are evaluating the activity of tosedostat in combination with standard agents in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Opaxio

Opaxio is a biologically enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. Taxanes, including paclitaxel (Taxol) and docetaxel (Taxotere), are used for the treatment of various solid tumors, including non-small cell lung, ovarian, breast and prostate cancers. Opaxio is designed to deliver paclitaxel preferentially to tumor tissue. The GOG-0212 study is a randomized, multicenter, open-label Phase III trial of either monthly Opaxio or paclitaxel for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane-based therapy.

Company Address

CTI Biopharma Corp

3101 Western Ave Ste 800
SEATTLE   WA   98121-3017
P: +1206.2827100
F: +1206.2846206

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