Cell Therapeutics (CTIC) Up, Incyte (INCY) Down on FDA Agreement

Joel Anderson  |

Seattle-based biopharmaceutical micro cap Cell Therapeutics, Inc. (CTIC) leapt over 17.5 percent in early trading on Monday, carrying on a strong run that dates back to September 11th and has seen the company’s shares gain over 65 percent in value.

Cell Therapeutics Reaches Agreement with FDA on Myelofibrosis Trial

The spike in the stock’s value comes after the company announced an agreement with the FDA over the design of a pivotal late-stage study for Cell’s drug pacritinib. The drug, intended for treating the blood disorder myelofibrosis, will be tested against the current best-available treatment in a 300-patient, 24-week Phase-III study in accordance with a Special Protocol Assessment (SPA). Myelofibrosis is a blood disorder that causes abnormal blood cells to build up in bone marrow, blocking the development of new, healthy cells. This shortage causes other organs, like the liver and spleen, to begin producing blood cells and can result in anemia, fatigue, pain, and swelling of the spleen.

Meanwhile, shares of Incyte (INCY) plunged nearly 4 percent, most likely on the news of Cell’s agreement with the FDA. Incyte makes Jakafi, the current best-available treatment that pacritinib will be compared with during the trial, and a successful Phase-III trial could mean a loss of market share for Incyte.

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Improved Outlook for FDA Approval

Reaching an agreement with the FDA prior to the beginning of the study typically means that the drug is more likely to receive approval should it meet its clinical goals.

"The FDA worked closely with us to achieve SPA agreement during first cycle review of the PERSIST-2 trial protocol for pacritinib," stated CTI President and CEO James A. Bianco, M.D. "As a result of the SPA, which established agreement on trial design to support regulatory approval, we expect that we will be able to initiate this pivotal Phase 3 clinical trial of pacritinib by the end of the year.  Myelofibrosis is a chronic disease and JAK inhibitors have had a dramatic impact on the lives of people living with myelofibrosis.  Data from earlier studies of pacritinib showed a clinically meaningful improvement in symptoms with minimal suppression of platelets or red blood cells.  We believe patients with myelofibrosis, particularly those with low platelet counts, could benefit from new treatment options."

New Treatment Could Join Successful NHL Drug

The recent run on shares of Cell Therapeutics began immediately after the company announced on September 11th that it had initiated the commercial launch of Pixuvri® in the European Union. Pixuvri is a non-Hodgkin Lymphoma (NHL) treatment and the only other approved drug in Cell’s product portfolio.

"Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," said Dr. Ruth Pettengell, principal investigator of the Phase III EXTEND study for Pixuvri. "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."

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