Key Developments: Cell Therapeutics Inc (CTIC.W)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Cell Therapeutics Inc Secures $15 Million Loan Financing Agreement
Cell Therapeutics Inc announced it has entered into a loan agreement with Hercules Technology Growth Capital, Inc. providing for a senior secured term loan of up to $15 million. The first $10 million of the term loan was funded at closing, and the remaining $5 million is available at CTI's option at any time from November 30 through December 15, 2013, subject to the satisfaction of certain conditions. The term loan is repayable over 42 months after closing, including an initial interest-only period of 12 months after closing. CTI granted Hercules warrants to purchase shares of common stock in an amount of up to 5% of the total loan commitment. Full Article
Cell Therapeutics Inc Announces Data Safety And Monitoring Board Recommendation To Continue GOG-0212 Phase 3 Clinical Trial Of Opaxiotm As Maintenance Therapy In Ovarian Cancer
Cell Therapeutics Inc announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis. CTI remains blinded to the interim analysis results. GOG-0212 is the maintenance study in this setting, having enrolled approximately 1,000 of the planned 1,100 patients. Enrollment is expected to be completed in 2013. The trial is being conducted and managed by the GOG. The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly OPAXIO or Taxol for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. For purposes of registration, the primary endpoint of the study is overall survival of OPAXIO compared to surveillance. Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The Company expects the next interim analysis to occur in the second half of 2013. Full Article
Cell Therapeutics Inc Begins Enrollment in Phase 3 PERSIST-1 Trial of Pacritinib for the Treatment of Myelofibrosis
Cell Therapeutics Inc announced that it has initiated clinical trial sites and began enrolling patients in a Phase 3 clinical trial, known as PERSIST-1 or PAC325, for pacritinib, CTI's investigational JAK2 inhibitor, which is being evaluated for the treatment of patients with myelofibrosis. The randomized trial is expected to enroll 270 patients and will evaluate the safety and efficacy of pacritinib compared to best available therapy, excluding JAK inhibitors, in patients with myelofibrosis. Pacritinib is a selective oral JAK2 inhibitor that demonstrated meaningful clinical benefits and good tolerability in myelofibrosis patients in Phase 2 clinical trials, without apparent drug-related thrombocytopenia or anemia. Myelofibrosis patients will be enrolled in the PERSIST-1 trial without exclusion for low platelet counts. Full Article
Cell Therapeutics Inc Announces Preclinical Study Providing Potential Mechanisms for Lower Cardiotoxicity in Patients with Multiply Relapsed or Refractory Aggressive B-cell NHL Treated with Pixuvri
Cell Therapeutics Inc announced the publication of results from a preclinical study of Pixuvri (pixantrone) in The Journal of Pharmacology and Experimental Therapeutics providing potential mechanisms for lower cardiotoxicity in patients treated with Pixuvri who received prior doxorubicin therapy. While CHOP-R is considered an effective therapy and is the standard of care in first line treatment of aggressive B-cell non-Hodgkin lymphoma (NHL), exposure to cumulative doses of doxorubicin, an anthracycline contained in this regimen, is associated with increasing the incidence of irreversible, severe, and symptomatic cardiac toxicity. The association with heart damage limits the use of doxorubicin and other anthracyclines beyond first line therapy and in patients with pre-existing cardiac disease. Full Article
Cell Therapeutics Inc Closes Underwritten Public Offering of USD 60 Million of Convertible Preferred Stock
Cell Therapeutics Inc (CTI) announced that on October 11, 2012 there has been the closing of its previously announced underwritten public offering of 60,000 shares of its Series 17 Preferred Stock, sold at a price to the public of USD 1,000 per share of Series 17 Preferred Stock (the Offering). Each share of Series 17 Preferred Stock is convertible at the option of the holder, at any time, into approximately 714 shares of common stock at a conversion price of USD 1.40 per share of common stock, for a total of approximately 42.9 million shares of common stock. The shares of Series 17 Preferred Stock will automatically convert into shares of common stock in certain circumstances. Shares of the Series 17 Preferred Stock will receive dividends in the same amount as any dividends declared and paid on shares of common stock, but would be entitled to a liquidation preference over the common stock in certain liquidation events. The Series 17 Preferred Stock will have no voting rights on general corporate matters. CTI received approximately $55.6 million in net proceeds from the Offering after deducting commission and expenses and other estimated offering expenses payable by CTI. Jefferies & Company, Inc. acted as sole book-running manager for the Offering. Roth Capital Partners, LLC and ThinkEquity LLC acted as co-managers for the Offering. Full Article
Cell Therapeutics Inc Prices Underwritten Public Offering of $60 Million of Convertible Preferred Stock
Cell Therapeutics Inc announced the pricing of an underwritten public offering of 60,000 shares of its Series 17 Preferred Stock, offered at a price to the public of $1,000 per share of Series 17 Preferred Stock (the Offering). Each share of Series 17 Preferred Stock is convertible at the option of the holder, at any time, into approximately 714 shares of common stock at a conversion price of $1.40 per share of common stock, for a total of approximately 42.9 million shares of common stock. The shares of Series 17 Preferred Stock will automatically convert into shares of common stock in certain circumstances. Shares of the Series 17 Preferred Stock will receive dividends in the same amount as any dividends declared and paid on shares of common stock, but would be entitled to a liquidation preference over the common stock in certain liquidation events. The Series 17 Preferred Stock will have no voting rights on general corporate matters. The gross proceeds to CTI from this Offering are expected to be $60 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by CTI. CTI estimates that its net proceeds from the Offering after deducting commission and expenses and other estimated offering expenses payable by CTI will be approximately $55.6 million. Jefferies & Company, Inc. is acting as sole book-running manager for the Offering. Roth Capital Partners, LLC and ThinkEquity LLC are acting as co-managers for the Offering. Full Article
Cell Therapeutics Inc Announces Proposed Public Offering Of Convertible Preferred Stock
Cell Therapeutics Inc announced that it intends to offer and sell, 40,000 shares of its Series 17 Preferred Stock in an underwritten public offering(the Offering). Each share of Series 17 Preferred Stock will have a stated value of $1,000 per share and will be convertible at the option of the holder, at any time after issuance, into shares of common stock prior to the automatic conversion of such shares in certain circumstances. Shares of the Series 17 Preferred Stock will receive dividends in the same amount as any dividends declared and paid on shares of common stock, but would be entitled to a liquidation preference over the common stock in certain liquidation events. The Series 17 Preferred Stock will have no voting rights on general corporate matters. CTI plans to use the net proceeds from this Offering to support the launch of Pixuvri (pixantrone) in Europe and to commence phase III trials of pacritinib as well as for general corporate purposes, which may include, among other things, funding research and development, preclinical and clinical trials, the preparation and filing of new drug applications, the acquisition of complementary businesses, technologies or products and general working capital. Jefferies & Company, Inc. is acting as sole book-running manager for the Offering. Roth Capital Partners, LLC and ThinkEquity LLC are acting as co-managers for the Offering. Full Article
Cell Therapeutics Inc's OPAXIOTM Receives Orphan Drug Designation For Malignant Brain Cancer From FDA
Cell Therapeutics Inc announced that OPAXIO (paclitaxel poliglumex) has been granted orphan-drug designation by the U.S Food and Drug Administration (FDA) for the treatment of glioblastoma multiforme (GBM), a malignant brain cancer. Orphan designation was granted based on preliminary activity seen from phase 2 results of OPAXIO when added to standard therapy (temozolamide (TMZ) plus radiation). In this study, progression-free and overall survival was encouraging among patients with GBM, including patients whose tumors expressed unmethylated MGMT. Current standard therapy is less effective in patients with tumors that have unmethylated MGMT, an important DNA repair enzyme. A randomized trial is now underway for patients with GBM with unmethylated MGMT comparing standard TMZ and radiation to OPAXIO and radiation. Orphan-drug designation is granted by the FDA to drugs that seek to treat a rare disease or condition. Full Article
Cell Therapeutics Inc's Highly Selective Oral JAK 2 Inhibitor, Pacritinib, Demonstrates Encouraging Anti-tumor Activity in Patients with Relapsed/Refractory Lymphoma
Cell Therapeutics Inc announced that the phase 1 study data of its highly selective oral JAK2 inhibitor pacritinib, or SB1518, showed encouraging anti-tumor activity and good tolerability in 34 patients with relapsed/refractory lymphoma. The results were published online in the Journal of Clinical Oncology in September, 2012. Thirty-four patients received daily oral doses of pacritinib ranging from 100mg to 600mg. The maximal tolerated dose was not reached. Median time on study was 88 days (range of one to 574 days) with six patients on pacritinib for longer than six months. Seventeen of the 34 patients (50%) had measurable decreases in target tumor measurements ranging from 4% to 70% shrinkage. Partial remissions were noted in three patients (mantle cell (2), indolent lymphoma (1)) while 15 patients had stable disease. Median progression free and overall survival was 120 and 130 days, respectively. Gastrointestinal (GI) side effects were most frequent and mild to moderate (grade 1-2) with no patient reporting severe (grade 3-4) GI side effects even at the 600mg dose level. Cytopenias were infrequent and modest (less than 15% all grades). The primary objective was a dose finding, pharmacokinetic/pharmacodynamics study of oral pacritinib in patients with relapsed lymphoma. Full Article
Cell Therapeutics Inc Readies Pixuvri European Launch And Start Of Pacritinib Phase 3 Trial
Cell Therapeutics Inc announced that the European Commission granted conditional marketing authorization for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL). The Company also announced that it will start pivotal studies for its JAK2 inhibitor, pacritinib. Full Article
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