%u25BA Cell Therapeutics’ Indolent NHL Agent Gets Fast Tracked
Cell Therapeutics, Inc. (CTI) received fast track designation for Pixantrone being investigated for the treatment of relapsed or refractory indolent non-Hodgkin’s lymphoma (NHL).
Pixantrone is an anthracenedione designed to reduce cumulative heart damage normally associated with the anthracycline-based anticancer agents. In designing Pixantrone, scientists removed the functional groups in the traditional anthracycline molecules that are thought to cause heart damage through the production of free-radicals. At the same time, they reportedly retained and enhanced those functional groups believed to be responsible for antitumor activity.
Pixantrone also is easier to administer than traditional anthracyclines because it is nontoxic to tissues and can be administered by a peripheral intravenous line, eliminating the need for a central line, explained Jack W. Singer, MD, chief medical officer, Cell Therapeutics, Inc.
CTI is also investigating Pixantrone in aggressive NHL. “With fast track designation already granted for pixantrone in aggressive NHL, this designation for indolent NHL is an important step in the development of this product and may help us bring this potentially life-saving drug to patients more quickly,” stated James A. Bianco, MD, President and Chief Executive Officer of CTI.
CTI has received feedback from the FDA on the design of its PIX303 trial, which will examine the time to disease progression for the combination regimen of fludarabine, pixantrone, and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have failed up to five prior treatments for relapsed or refractory NHL. The trial is expected to enroll 300 patients beginning in the second quarter with interim data by mid-2008, Dr. Singer reported.
Pixantrone is currently in a Phase III single-agent trial known as EXTEND and a Phase II combination study known as RAPID both in aggressive NHL. EXTEND is evaluating Pixantrone’s role as a salvage regimen in patients with relapsed aggressive NHL and is currently enrolling patients. “A second interim analysis of this study will be performed on approximately 100 patients and is targeted for the second half of 2007,” commented Dr. Singer.
RAPID is a first-line study of a combination therapy where Pixantrone is substituted for the anthracycline doxorubicin in the CHOP-R (cyclophosphpamide, doxorubicin, vincristine, prednisone and rituximab) regimen. “The trial, which is currently enrolling patients, will explore the potential cardiac safety benefits of pixantrone in chemotherapy naïve patients when compared directly to doxorubicin,” according to Dr. Singer. “An interim analysis is planned in the second half of 2007.”
%u25BA First Low-Molecular-Weight Heparin Approved for Extended Treatment to Reduce the Recurrence of Blood Clots in
Patients with Cancer
The Food and Drug Administration sanctioned a new indication for Fragmin® (dalteparin sodium injection) for the extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in patients with cancer. Fragmin is the first low-molecular-weight heparin approved in the United States for the extended treatment of recurrent VTE in cancer patients, according to Judee Shuler, Director, Corporate Planning & Communications at Eisai.
“Patients with cancer have a seven-fold greater risk of VTE than noncancer patients,” Shuler explained, “so Fragmin will address an important unmet medical need.” Eisai licensed exclusive United States rights to promote Fragmin from Pfizer Inc. in September 2005. “The agreement was aimed at strengthening Eisai’s position in oncology and critical care in the United States,” Ms. Shuler noted. “This new indication will give Eisai the opportunity to further develop relationships with oncology health care professionals and deepen our understanding of this therapeutic category, helping us prepare for the potential launch of oncology drugs in our pipeline.”
Eisai has three compounds in Phase II devel¬opment for breast, prostate, and non-small cell lung cancer and three different Phase I candidates.
Fragmin has been on the market since December 1994 when it was approved for prophylaxis of deep vein thrombosis in patients undergoing abdominal surgery, Ms. Shuler said. In 1999, the FDA allowed patients undergoing hip replacement surgery access to the medication. Latter that same year, the drug was approved for prophylaxis of ischemic complications in unstable angina and non-Q-wave MI when concurrently administered with aspirin therapy. About four years later, Fragmin was green lighted for patients with severely restricted mobility during acute illness.
%u25BA ArQule Stands to Earn $123 Million in Deal with Kyowa