The class action lawsuit was filed on behalf of purchasers of the common stock of Cell Therapeutics, Inc. ("Cell Therapeutics " or the "Company") (Nasdaq: CTIC) between May 5, 2009 and February 8, 2010, inclusive (the "Class Period"), seeking to pursue remedies under the Securities Exchange Act of 1934 (the "Exchange Act").
The complaint charges Cell Therapeutics and certain of its officers and executives with violations of the Exchange Act. Cell Therapeutics develops, acquires, and commercializes oncology products for cancer treatment.
One of the products that the Company developed is Pixantrone, a phase III trial product for non-Hodgkin's lymphoma. The Company describes Pixantrone as a "novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents." The Company represents that Pixantrone, unlike other anthracyclines, is not "cardiotoxic."
The complaint alleges that, throughout the Class Period, defendants failed to disclose material adverse facts about the Company's business and prospects. Specifically, the complaint alleges that defendants failed to disclose: (a) that the Special Protocol Assessment ("SPA") with the United States Food and Drug Administration ("FDA") for Pixantrone was invalidated in March 2008; (b) that the Company's Pixantrone study enrolled a large number of patients who did not suffer from aggressive non-Hodgkin's lymphoma; (c) that the Company's Pixantrone drug was cardiotoxic; and (d) that, as a result of the foregoing, defendants lacked a reasonable basis for their positive statements about Pixantrone and its prospects.
On February 8, 2010, the FDA posted its assessment of Pixantrone in advance of its February 10, 2010 advisory meeting. With regard to the regulatory history of Pixantrone, the FDA Briefing Document stated, among other things, that the Company's SPA was invalidated in March 2008 and that the Company's Pixantrone study results were not meeting the FDA's standards for approval.
