Von Hoff details CTI's new cancer drug development platform
SEATTLE, Nov. 14 /PRNewswire-FirstCall/ -- Analysts, fund managers, and investors heard first-hand the progress and prospects of three of Cell Therapeutics, Inc.'s (CTI) (Nasdaq: CTIC and MTAX: CTIC) oncology drug candidates, as well as information on a drug CTI expects to acquire this year, from an international panel of clinical investigators at a Company-sponsored analyst day entitled "New Strategies, New Opportunities" in New York on Friday, November 9.
Leading off the meeting was oncology drug development expert Daniel D. Von Hoff, M.D., Physician-in-Chief of the Translational Genomics Research Institute (TGen), Clinical Professor of Medicine at the University of Arizona, and Chief Scientific Officer at U.S. Oncology. Dr. Von Hoff introduced the emerging platform of using clinical and genomic evaluation of tumors to guide oncology clinical trials as a method to increase the likelihood of success while potentially decreasing development time and expense. "Leveraging its unique relationship with TGen, through their acquisition of Systems Medicine, CTI is one of the first companies to adopt this strategy of onco-genomic guided clinical trials," noted Von Hoff. "This represents an exciting convergence of genomics, small inhibitors of RNA (SiRNA), bioinformatics, and cancer drug development. You have to admire CTI for quickly integrating these powerful tools to design current and future clinical trials like those being conducted or contemplated for brostallicin," Von Hoff said. ZEVALIN(R) (Ibritumomab Tiuxetan)
Fredrick B. Hagemeister, M.D., Professor of Medicine at The University of Texas M. D. Anderson Cancer Center gave an overview of ZEVALIN, a radiopharmaceutical which CTI has agreed to acquire from Biogen Idec. Commenting on the slow adoption of ZEVALIN by doctors, Dr. Hagemeister said that increased adoption of ZEVALIN may be more likely if the clinical data supporting its use "becomes so compelling that physicians will administer ZEVALIN as a follow-up drug in consolidation. While I don't know the FIT trial data, it would appear those results may provide such a compelling reason given that the study was closed early because of the significant benefit on progression-free survival in patients who received ZEVALIN as consolidation therapy."
Bayer HealthCare, the sponsor of the ZEVALIN FIT trial (First-line Indolent Trial), a multinational, randomized phase III trial of ZEVALIN after first-line induction chemotherapy, recently announced that the trial met its primary endpoint - demonstrating an improvement in progression-free survival (PFS). The results of this trial will be presented in an oral presentation (abstract #643) on Monday, Dec. 10, 2007 at the 49th Annual Meeting of the American Society of Hematology (ASH) in Atlanta. CTI's acquisition of ZEVALIN remains subject to closing conditions, including obtaining certain third party consents, and until the acquisition is closed, ZEVALIN remains a product and trademark of Biogen Idec.
Pixantrone (BBR 2778)
Peter Borchmann, M.D., Ph.D., Senior Consultant of Hematology and Oncology at the University Hospital of Cologne, reviewed the phase I and II studies of pixantrone and the strong rationale for the design of the ongoing phase III studies in non-Hodgkin's lymphoma (NHL). "Having worked with pixantrone for the past nine years, I am delighted to see CTI invest in completing the phase III trials to establish the efficacy, overall safety, and cardiac safety profile of pixantrone. In our experience in the early clinical study results of pixantrone, we've seen low incidences of cardiotoxicity despite prior anthracycline exposure in all of these patients," Dr. Borchmann commented. Anthracyclines are an established cornerstone treatment and potentially curative in breast cancer, acute leukemia, and lymphoma therapy, however anthracyclines cause cumulative acute and chronic irreversible damage to the heart muscle.
XYOTAX(TM) (paclitaxel poliglumex, CT-2103)
A founding member of the British Thoracic Oncology Group (BTOG) and Clinical Director of the HOPE Directorate at St. James' Hospital, Kenneth J. O'Byrne, M.D., presented the phase III results of XYOTAX in first-line treatment of non-small cell lung cancer noting that "equivalent survival to gemcitabine or vinorelbine in poor performance status patients and the reduction in toxicity coupled with the convenience of administration is very important and it's on the basis of this that positive advice has been received from the EMEA in Europe." Dr. O'Byrne also presented data suggesting that XYOTAX may be particularly effective in women with pre-menopausal estradiol levels where survival appears better than in similar patients treated with conventional chemotherapy.
Brostallicin has been studied in combination with classic anti-cancer agents and with new molecularly targeted agents in more than 200 patients in phase I and II clinical trials. In addition to its unique mechanism of action as a minor groove binder, brostallicin has a good safety profile with no cumulative marrow toxicities to-date. Dr. Von Hoff said, "It meant a lot to us to have the EORTC set up a randomized phase II trial comparing brostallicin to doxorubicin, which is the standard treatment, because it demonstrates a level of confidence in the drug. Utilizing genomic screening for a tumor's context of vulnerability has helped design and guide ongoing and planned phase II trials of brostallicin."
James A. Bianco, M.D., CTI's President and CEO summarized the day's presentations by highlighting the near-term regulatory milestones for CTI's late-stage pipeline. "With the potential for compelling consolidation data with ZEVALIN in follicular lymphoma stemming from the FIT trial, and once the acquisition of ZEVALIN is completed, we expect to file for a label expansion by mid-2008 potentially making ZEVALIN the treatment of choice for consolidating and maintaining remissions in the first-line treatment of this disease. This could significantly expand the commercial prospects of this therapy in 2009. With a marketing application submission (MAA) for XYOTAX on schedule for the first half of 2008, coupled with pivotal trial data from pixantrone and a supplemental BLA filing for ZEVALIN all targeted by mid-2008, the next 12 months will be a transforming time for CTI and its shareholders taking us closer to our goal of breaking even," Dr. Bianco concluded. All presentations are available for play-back in their entirety at http://www.cticseattle.com
ZEVALIN(R) (Ibritumomab Tiuxetan) 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. Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab 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.
Pixantrone (BBR 2778) is an investigational agent under development for the potential treatment of various hematological malignancies, solid tumors and immunological disorders. It was developed to improve the activity and safety of the anthracycline family of anti-cancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types. However, they are usually associated with cumulative heart damage that prevents them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplify administration compared to currently marketed anthracyclines.
XYOTAX(TM) (paclitaxel poliglumex, CT-2103) is a biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy 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 XYOTAX 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 XYOTAX 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.
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 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.cticseattle.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 marketing and development of ZEVALIN or the development of XYOTAX, pixantrone, and brostallicin include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with ZEVALIN, XYOTAX, pixantrone, and brostallicin in particular including, without limitation, the potential failure of the closing f the acquisition of ZEVALIN, the potential failure of XYOTAX, pixantrone, or brostallicin as product candidates to prove safe and effective for treatment of non-small cell lung cancer, ovarian cancer, non-Hodgkin's lymphoma, and sarcoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling ZEVALIN, XYOTAX, pixantrone and brostallicin, as well as the risk that we may not be able to complete the ZEVALIN acquisition or, if the ZEVALIN acquisition is accomplished, the risk of potential failure of obtaining approval from the FDA for label expansion of ZEVALIN, 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.
Medical Information Contact:
|SOURCE Cell Therapeutics, Inc.|
Copyright©2007 PR Newswire.
All rights reserved