SEATTLE, May 26, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ: CTICD and MTA: CTIC) today announced that consistent with its previously announced pipeline strategy, CTI has identified a potential acquisition opportunity that is a phase II drug candidate being investigated in the field of cancer immunotherapy. Called antigen presenting cell or APC activators, these protein therapeutics activate macrophages and dendritic cells to present foreign antigens to T-killer cells and T-memory cells thus activating a tumor specific immune attack with potential lifelong immunity against the cancer.
"We are excited by the prospect of potentially acquiring this novel tumor specific and individualized approach for harnessing a patient's immune system to fight and potentially eradicate cancer and look forward to advancing our discussions and due diligence to a point where this product could become an addition to our diversified oncology drug pipeline," said James A Bianco, M.D., CEO of CTI. "With the recent successful outcome of our appeal with the Office of New Drugs at the U.S. Food and Drug Administration (the "FDA"), we have the potential for pixantrone to be approved in the U.S. solely on the basis of the existing PIX301 clinical trial results within six months of our re-submission of our New Drug Application ("NDA") for pixantrone. We believe, along with potential E.U. approval of pixantrone by year end expanding our pipeline with additional novel late stage agents like our recent in-license of tosedostat as well moving into the emerging field of cancer immunotherapy is a smart strategic directive for the continued future growth of CTI. We look forward to updating you on these and other exciting developments in the near future."
ASCO reminder
CTI will have two of its drug candidates as the subject of American Society of Clinical Oncology (ASCO) presentations which include interim data from a study with OPAXIO™ (paclitaxel poliglumex or PPX), in patients with newly diagnosed high-grade gliomas, and interim results from a study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia ("AML"), which will be presented at the ASCO meeting, June 3-7, 2011 in Chicago, Illinois. Both studies were selected for oral poster discussion sessions.
The OPAXIO study poster will be posted on Friday, June 3, 2011 during the Central Nervous System Tumors session that will be held from 2:00 to 6:00 p.m., and will be part of an oral discussion session from 5:00 to 6:00 p.m. Central Time. The presentation, abstract #2036, is titled, "A phase II study of paclitaxel poliglumex (PPX), temozolamide (TMZ), and radiation (RT) for newly diagnosed high-grade gliomas." The tosedostat study poster will also be posted on Friday, June 3, 2011, during the Leukemia, Myelodysplasia, and Transplantation session that will be held from 2:00 to 6:00 p.m., and will be included in a discussion session from 5:00 to 6:00 p.m. Central Time. The presentation, abstract #6517, is titled, "Interim results of OPAL, a study of tosedostat in elderly relapsed/refractory AML." The study abstracts are available at www.asco.org.
CTI to host investor and analyst lunch on novel therapies for hematologic malignancies
CTI will host an investor and analyst event to discuss its drug candidate tosedostat, an oral aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials, and other novel targeted therapies for hematological malignancies.
Speakers at the event will include Hagop M. Kantarjian, M.D., Jorge Cortes, M.D., and Srdan Verstovsek, M.D., Ph.D., all of the MD Anderson Cancer Center. The event will be held Saturday, June 4, 2011, and the presentation will begin at 11:45 a.m. Central time /6:45 p.m. Central European time/ 9:45 a.m. Pacific time and conclude at approximately 1:00 p.m. Central time /8:00 p.m. Central European time/11:00 a.m. Pacific time. The presentations will be webcast live with slides at www.celltherapeutics.com.
About OPAXIO(TM)
OPAXIO™ (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX™, 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, 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 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.
About Tosedostat
Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central and South America.
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.
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert
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 OPAXIO and tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with OPAXIO and tosedostat in particular including, without limitation, the potential failure of OPAXIO to prove safe and effective for the treatment of gliomas, including newly diagnosed high-grade gliomas, the potential failure of tosedostat to prove safe and effective for the treatment of AML, determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling OPAXIO and tosedostat, that CTI may not be able to obtain FDA and/or European Medicines Agency (the "EMA") approval of pixantrone without conducting an additional clinical trial, that CTI may not be able to obtain FDA and/or approval of pixantrone in the United States or the European Union, that CTI may not be able to FDA and/or EMA approval of pixantrone by year end, that CTI may not be able to obtain FDA approval of pixantrone within six months of resubmission of the NDA, that CTI may not be able to acquire this product candidate, that the product candidate may not activate macrophages and dendritic cells to present foreign antigens to T-killer cells and T-memory cells thus activating a tumor specific immune attack with potential lifelong immunity against the cancer, that the product candidate may not eradicate cancer, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:Dan Eramian T: 206.272.4343C: 206.854.1200E: [email protected]www.CellTherapeutics.com/press_roomInvestors Contact:Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: [email protected]www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
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"We are excited by the prospect of potentially acquiring this novel tumor specific and individualized approach for harnessing a patient's immune system to fight and potentially eradicate cancer and look forward to advancing our discussions and due diligence to a point where this product could become an addition to our diversified oncology drug pipeline," said James A Bianco, M.D., CEO of CTI. "With the recent successful outcome of our appeal with the Office of New Drugs at the U.S. Food and Drug Administration (the "FDA"), we have the potential for pixantrone to be approved in the U.S. solely on the basis of the existing PIX301 clinical trial results within six months of our re-submission of our New Drug Application ("NDA") for pixantrone. We believe, along with potential E.U. approval of pixantrone by year end expanding our pipeline with additional novel late stage agents like our recent in-license of tosedostat as well moving into the emerging field of cancer immunotherapy is a smart strategic directive for the continued future growth of CTI. We look forward to updating you on these and other exciting developments in the near future."
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ASCO reminder
CTI will have two of its drug candidates as the subject of American Society of Clinical Oncology (ASCO) presentations which include interim data from a study with OPAXIO™ (paclitaxel poliglumex or PPX), in patients with newly diagnosed high-grade gliomas, and interim results from a study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia ("AML"), which will be presented at the ASCO meeting, June 3-7, 2011 in Chicago, Illinois. Both studies were selected for oral poster discussion sessions.
The OPAXIO study poster will be posted on Friday, June 3, 2011 during the Central Nervous System Tumors session that will be held from 2:00 to 6:00 p.m., and will be part of an oral discussion session from 5:00 to 6:00 p.m. Central Time. The presentation, abstract #2036, is titled, "A phase II study of paclitaxel poliglumex (PPX), temozolamide (TMZ), and radiation (RT) for newly diagnosed high-grade gliomas." The tosedostat study poster will also be posted on Friday, June 3, 2011, during the Leukemia, Myelodysplasia, and Transplantation session that will be held from 2:00 to 6:00 p.m., and will be included in a discussion session from 5:00 to 6:00 p.m. Central Time. The presentation, abstract #6517, is titled, "Interim results of OPAL, a study of tosedostat in elderly relapsed/refractory AML." The study abstracts are available at www.asco.org.
CTI to host investor and analyst lunch on novel therapies for hematologic malignancies
CTI will host an investor and analyst event to discuss its drug candidate tosedostat, an oral aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials, and other novel targeted therapies for hematological malignancies.
Speakers at the event will include Hagop M. Kantarjian, M.D., Jorge Cortes, M.D., and Srdan Verstovsek, M.D., Ph.D., all of the MD Anderson Cancer Center. The event will be held Saturday, June 4, 2011, and the presentation will begin at 11:45 a.m. Central time /6:45 p.m. Central European time/ 9:45 a.m. Pacific time and conclude at approximately 1:00 p.m. Central time /8:00 p.m. Central European time/11:00 a.m. Pacific time. The presentations will be webcast live with slides at www.celltherapeutics.com.
About OPAXIO(TM)
OPAXIO™ (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX™, 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, 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 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.
About Tosedostat
Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central and South America.
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.
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert
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 OPAXIO and tosedostat include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with OPAXIO and tosedostat in particular including, without limitation, the potential failure of OPAXIO to prove safe and effective for the treatment of gliomas, including newly diagnosed high-grade gliomas, the potential failure of tosedostat to prove safe and effective for the treatment of AML, determinations by regulatory, patent, and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing, and selling OPAXIO and tosedostat, that CTI may not be able to obtain FDA and/or European Medicines Agency (the "EMA") approval of pixantrone without conducting an additional clinical trial, that CTI may not be able to obtain FDA and/or approval of pixantrone in the United States or the European Union, that CTI may not be able to FDA and/or EMA approval of pixantrone by year end, that CTI may not be able to obtain FDA approval of pixantrone within six months of resubmission of the NDA, that CTI may not be able to acquire this product candidate, that the product candidate may not activate macrophages and dendritic cells to present foreign antigens to T-killer cells and T-memory cells thus activating a tumor specific immune attack with potential lifelong immunity against the cancer, that the product candidate may not eradicate cancer, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:Dan Eramian T: 206.272.4343C: 206.854.1200E: [email protected]www.CellTherapeutics.com/press_roomInvestors Contact:Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: [email protected]www.CellTherapeutics.com/investors
SOURCE Cell Therapeutics, Inc.
