Knobias Clip Report (03-05-2008)
Submitted By Knobias ClipReport
CTIC: CEO Discusses Recent Transactions and Milestones
Shares of Cell Therapeutics Inc (CTIC) were higher on heavy volume Wednesday following the publication by two European institutions of results of a limited phase II study of CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by administration of the Company’s Zevalin(R) (Ibritumomab Tiuxetan) in elderly patients (60 years of age or older) with previously untreated diffuse large B-cell lymphoma (DLBCL). In this study, 20 previously untreated elderly patients were treated with a novel combination of six cycles of CHOP chemotherapy followed by Zevalin given six to ten weeks later. The study, which had an overall response rate of 100%, including a 95% complete remission rate, indicated the efficacy, tolerability, and feasibility of this regimen for these patients.
Zevalin(R) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Cell Therapeutics also has three product candidates in late-stage clinical development— pixantrone (non-Hodgkin’s lymphoma), XYOTAX(TM)(non-small cell lung cancer and ovarian cancer) and brostallicin (relapsed/refractory soft tissue sarcoma), and a robust clinical and preclinical product pipeline.
A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) as a first-line treatment for patients with non-small cell lung cancer (NSCLC) who have ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The application will be formally reviewed for validation by the end of March. Upon validation, the marketing approval review process begins, which generally takes 15 to 18 months.
The Company reported yesterday that it will issue approximately $51.7 million of new 9% Convertible Senior Notes due 2012 and warrants to purchase 7,326,950 shares of common stock. The warrants will have an exercise price of $1.41 per share. A substantial number of existing holders of the Company’s Series A 3% Convertible Preferred Stock, Series B 3% Convertible Preferred Stock, Series C 3% Convertible Preferred Stock and Series D 7% Convertible Preferred Stock have also converted their shares of Preferred Stock into common stock.
The President and CEO of Cell Therapeutics, Dr. James A. Bianco, stated in a conference call today, “Over the past six to eight months, a number of analysts and institutional fund managers have advised us of the need to remove the $55 million convertible debt on our balance sheet. In addition, there was a need to work out a solution related to the preferred securities. We now have a manageable debt of $10 million, which we intend to pay back in cash. This transaction should help to unlock the potential equity upside of our oncology profile.”
“We have transformed this company to a commercial entity. The fundamentals of the company are strong. How many publicly-traded micro-cap biotech companies have a marketed product that is expected to generate $15 million in net sales this year, let alone, submitted a Marketing Authorization Application in a partnership with Novartis. In addition, we are completing a pivitol Phase III program on a third product with expected results this summer.”
“We are continuing to focus on reducing our operating expenses and are exploring several novel strategies to build value from subsidiaries and our Italian branch. In the next twelve to eighteen months, we can build on the value that is currently under-appreciated in the market.”
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