Healthcare Industry News: OPAXIO
News Release - August 5, 2008
Craig W. Philips Takes Helm at CTIPresident assumes day to day commercial and development responsibilities
SEATTLE, Aug. 5 (HSMN NewsFeed) -- Cell Therapeutics, Inc. (the "Company") (Nasdaq: CTIC; MTA) t announced that Craig W. Philips has assumed his role as CTI's new President, and will concentrate on managing the company's drug development and commercial operations. Most recently, Philips was Vice President and General Manager of Bayer Healthcare Oncology. He will report to CTI's James A. Bianco, M.D., who has served as President and Chief Executive Officer since its founding and will remain with the company as CEO.
"Bringing Craig Philips on board at this time represents a milestone at CTI as the company has shifted from a research and development organization to a commercial operating company with the potential to expand the market indication for Zevalin«, report pixantrone pivotal trial results, and potentially file a NDA, as well as the potential for an OPAXIO(TM) launch in 2009," said Bianco.
"With the opportunity to bring two new cancer drugs to market and expand the label of another in the near term, CTI could transform itself into a successful commercial enterprise," said Philips. "I look forward to helping to bring value to CTI shareholders, and to improving the treatment options available to individuals suffering with cancer."
In late 2007, CTI acquired the U.S. sales and marketing rights to Zevalin, a drug for treating relapsed follicular non-Hodgkin's lymphoma (NHL). The full marketing and sales team has recently come on line, and Zevalin sales for 2008 are on track at a projected $15 million for the year. Recently, CTI has gained access rights to Bayer's FIT trial data, and will meet with the Food and Drug Administration (FDA) in September to discuss label expansion in the U.S. The phase III First-line Indolent Trial (FIT) evaluated the benefit and safety of a single dose of Zevalin in patients with CD20-positive follicular lymphoma who had achieved a full or partial remission following first-line chemotherapy treatment.
In addition CTI has submitted an application for approval to market its lung cancer drug candidate OPAXIO in Europe and expects to receive a response from the European Medicines Agency (EMEA) regarding that application in 2009, and also expects final data on another late stage phase III drug, pixantrone, for relapsed or refractory aggressive NHL in the second half of 2008. Positive pixantrone data could allow CTI to submit an application for FDA approval in early 2009. OPAXIO is also being studied independently in a phase III trial for ovarian cancer, with interim data results expected in late 2009.
Pixantrone is an investigational agent under development for the potential treatment of various blood cancers. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents and to reduce the potential for the most common side effects of anthracyclines, severe cardiotoxicities and cumulative heart damage.
CTI has a worldwide licensing agreement with Novartis on OPAXIO. Novartis also holds an option for an exclusive license for pixantrone.
CTI is also developing brostallicin, another cancer drug for sarcoma currently in phase II/III trials. Brostallicin, a novel synthetic second- generation DNA minor groove binder, has potent cancer killing activity and has demonstrated activity in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical, experimental tumor models.
Since 2006, Philips has been leading Bayer's U.S. oncology operations following the integration of the U.S. oncology businesses from Berlex and Bayer. In this capacity, he oversaw the U.S. oncology operations with sales of $350 million and a staff of over 150. Philips was also either a member or chair of alliance executive committees which included Onyx, Novartis, Genzyme, and Favrille.
Prior to Bayer Healthcare, Philips was the head of Berlex Oncology since 2004. He was responsible for the U.S. oncology operations with sales of over $160 million. Before Berlex, Philips was with Schering Plough in U.S., and international roles. He began his career with Bristol Myers, where he worked in a variety of therapy areas including oncology, cardiology, and CNS.
Zevalin« (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non- Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-na´ve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan«) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
Patients and healthcare professionals can visit http://www.zevalin.com for more information.
OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was previously branded as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol«, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is rendered inactive, potentially sparing normal tissue's exposure to high levels of the active drug and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies. This is being studied in an ongoing phase III trial.
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy, is a novel DNA major groove binder that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents. A new chemical compound for the treatment of non-Hodgkin's lymphoma (NHL), and various other hematologic malignancies, solid tumors, and immunological disorders, pixantrone is being developed by CTI to improve the activity and safety in treating cancers usually treated with the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types, such as lymphoma, leukemia, and breast cancer. For these diseases, anthracycline-containing chemotherapy regimens are effective in first-line (initial) treatment. However, they may cause cumulative heart damage that limits lifetime dosage and does not allow for retreatment. Pixantrone has been designed to reduce the potential for heart damage compared to currently available anthracyclines or anthracenediones without a loss in anti-tumor or immunomodulatory activities.
Brostallicin, a novel synthetic second-generation DNA minor groove binder, has potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumor models. Brostallicin binds covalently to DNA within the DNA minor groove, interfering with DNA division and leading to tumor cell death. More than 200 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma met its pre-defined activity and safety hurdles and resulted in a first-line phase II study that is currently being conducted by the European Organization for Research and Treatment of Cancer (EORTC).
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms -- aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute's SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that 66,120 people will be diagnosed with NHL in 2008 and more than 19,000 are expected to die.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.CellTherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of Zevalin, OPAXIO, pixantrone and brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin, OPAXIO, pixantrone and brostallicin in particular including, without limitation, the ability of the Company to continue to raise capital to fund its ongoing operations, or the potential failure of Zevalin to be approved by the FDA for first-line treatment of non-Hodgkin's lymphoma, the failure of OPAXIO, pixantrone or brostallicin to prove safe and effective for their intended uses, a determination by the EMEA that OPAXIO should not be approved for sale in Europe, other determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling Zevalin, OPAXIO, pixantrone and brostallicin, the risk that Novartis may not elect to participate in the development and marketing of OPAXIO or may not exercise its option with regard to pixantrone, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian law, CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Source: Cell Therapeutics
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