Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes and is among the most common cancers, accounting for about 4% of all incidences in the US. The American Cancer Society’s most recent estimates for NHL state that over 72,200 people will be diagnosed this year, with over 20,000 deaths expected. NHL is one of the more common cancers among children and teenagers, and the risk of developing NHL increases throughout life with more than half of patients 65 or older at the time of diagnosis.
We’ve been following CTI BioPharma (Nasdaq: CTIC), which has conditional approval from the European Commission to market pixantrone, a chemotherapeutic compound, for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. (B cells and T cells are the two main types of lymphocytes. NHL can develop from either one, but B-cell lymphomas are much more common in the US.) As part of the post-authorization requirement of this conditional approval, the company has been conducting a Phase 3 trial to evaluate pixantrone combined with rituximab (an antibody that can be used in conjunction with chemotherapy) in comparison to a combination of rituximab and gemcitabine (a chemotherapeutic drug) in patients with aggressive B-cell NHL. CTI BioPharma announced earlier today that it had completed patient enrollment in this trial, and that it expects top line results to be available in the first half of next year.
Yesterday, the company also announced that it had enrolled the first patient in its Phase 2 clinical trial of pacritinib, an oral kinase inhibitor (kinases can turn a protein on or off), for patients with primary myelofibrosis who have failed prior chemotherapy with ruxolitinib. Myelofibrosis is a cancer of the bone marrow that disrupts the normal production of blood cells. According to the Mayo Clinic, myelofibrosis results in extensive scarring in the bone marrow, leading to severe anemia, weakness, fatigue and often an enlarged spleen. This Phase 2 trial is expected to enroll up to approximately 105 patients.
Source: CTI BioPharma website
Pacritinib’s long journey
Readers who have followed CTI BioPharma will recall that pacritinib has had a rocky road, going back to the clinical hold that was issued by the FDA for toxicity concerns in February 2016 that made 75% of the company’s market value disappear in one day. To the company’s credit, it continued analysis and discussion with the FDA throughout last year, and there were reasons for optimism as the FDA had indicated in March 2016 that it would permit patients who were receiving benefit from pacritinib treatment at the time the clinical hold was imposed to resume treatment under a compassionate use program. Finally, in January 2017, the FDA removed the full clinical hold and permitted clinical trials to resume.
We believe that the FDA’s decision to permit continued study of pacritinib points to the potential of this compound. Pacritinib has been shown to have specificity for a group of enzymes that are a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine (small secreted proteins released by cells that have a specific effect on the interactions and communications between cells) expression and immune responses. Mutations in these enzymes have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms (abnormal growths of tissue), leukemia and lymphoma. In addition to myelofibrosis, the specificity of pacritinib for these enzymes suggests its potential therapeutic utility in numerous other types of cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome, chronic myelomonocytic leukemia and chronic lymphocytic leukemia.
CEO Adam Craig, MD, PhD, has been leading the company since March 2017, following the retirement last fall of CTI BioPharma’s founder and CEO, James Bianco. Dr. Craig worked previously as an independent consultant to CTI BioPharma and other hematology and oncology companies. Prior to consulting, Dr. Craig was Chief Medical Officer of Sunesis Pharmaceuticals and of Chemgenex Pharmaceuticals (acquired by Cephalon/Teva). He deserves to sit in the chair for more than a few months before a fair judgment can be made.
Another item on our radar is the company’s history of reverse stock splits. We believe there have been five in the 20 years in which the company has been public (the company was formerly known as Cell Therapeutics), with the most recent 1-for-10 reverse happening in January 2017. Readers know the disdain we have for reverse stock splits solely as a Nasdaq listing survival tactic, and shareholders should hope that there isn’t another one.
The company raised $45 million in gross proceeds in a convertible preferred stock offering in June 2017, which should help fund operations through most of 2018. We’ll be listening to the company’s Q2 update and conference call for more details tomorrow at 4:30pm ET. Investors may dial 1-888-471-3820 (domestic) or 1-719-325-2478 (international) or access the live audio webcast or subsequent archived recording at CTI BioPharma’s website.
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