Cell Therapeutics Reveals Drug Portfolio Progress, Outlook For 2014 - Update

(RTTNews) - Cell Therapeutics Inc. (CTIC) announced Tuesday an overview of recent progress for its drug portfolio, noting that it has entered 2014 with a series of successes.

President and CEO James Bianco stated that the biopharmaceutical company expects to continue that momentum with completion of the first of two Phase 3 clinical trials of pacritinib in myelofibrosis and potential topline data later in the year.

Bianco said, "We ended 2013 and have entered 2014 with a series of successes, including a global strategic partnership for pacritinib, positive reimbursement rulings in England/Wales and Germany for PIXUVRI, the reacquisition of rights to PIXUVRI and Opaxio in order to allow us to more efficiently move these programs forward and new positive interim data for tosedostat."

In its progress update, the company noted that in November 2013, it entered into a worldwide license agreement with Baxter International, Inc. to jointly commercialize pacritinib in the United States, while Baxter has exclusive commercialization rights for all indications outside the U.S.

CTI said it expects to report topline data from the ongoing Phase 3 PERSIST-1 trial in the second half of 2014. The trial evaluates a broad set of myelofibrosis patients without limitations on blood platelet counts. The company expects to initiate PERSIST-2 for patients with myelofibrosis who have low platelet counts in early 2014.

The company now anticipates that the up-front payment and anticipated near-term milestones related to the Baxter collaboration will potentially allow CTI to reach regulatory submissions for pacritinib without requiring additional equity financing to fund such activities.

Regarding PIXUVRI, (pixantrone), CTI said it has gained agreement from the European Medicines Agency to change the primary endpoint of the Phase 3 PIX-R, or PIX306, post-marketing commitment study of pixantrone-rituximab versus gemcitabine-rituximab for patients with relapsed B-cell non-Hodgkin lymphoma from overall survival to progression-free survival. The trial is now expected to enroll 220 patients versus the 350 patients previously planned.

The company expects the trial to complete enrollment in 2015. It is also intended to support the conversion of the conditional approval for PIXUVRI in Europe to full approval and potentially support a registration application in the U.S. The company also intends to pursue a partner for commercializing PIXUVRI outside of Western Europe.

In January 2014, CTI received notification from the FDA that the partial clinical hold has been removed for Tosedostat and all studies underway may continue. Current investigator-sponsored trials are scheduled to resume in the first quarter of 2014.

CTI also reached an agreement with Novartis to regain rights to PIXUVRI and Opaxio, providing CTI with the flexibility to manage these assets within the context of its overall product portfolio strategy.

CTI said it expects the Opaxio GOG-0212 Phase 3 maintenance therapy trial for patients with ovarian cancer to complete enrollment in the first quarter 2014.

In addition, the company said it will provide 2014 financial guidance in its fourth quarter and year-end 2013 results announcement.

Cell Therapeutics shares closed Monday's trading at $2.92, up $0.26 or 9.77 percent. In the after hours trading, shares gained $0.05 or 1.71 percent further to reach $2.97.