Phase II Trial of Belinostat (PXD101) in Combination with Velcade
CuraGen Corporation (Nasdaq: CRGN) and TopoTarget A/S announced a Phase II clinical trial evaluating the efficacy and safety of intravenous belinostat (PXD101), a small molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade(R) (bortezomib) for Injection, in multiple myeloma patients refractory to or who have rapidly relapsed from at least one previous bortezomib-containing regimen.
The Phase II clinical trial is being led by James Berenson, M.D., and will be conducted at multiple sites across the U.S. Up to 35 patients are planned for study enrollment with preliminary results anticipated by the end of 2007.
"Based on our preclinical studies that showed markedly increased anti-myeloma effects when belinostat was combined with bortezomib to treat a bortezomib-resistant myeloma in immunodeficient mice, we look forward to enrolling bortezomib-resistant multiple myeloma patients into this Phase II trial and determining whether the combination can provide clinical benefit to multiple myeloma patients that have failed, or who have relapsed on bortezomib therapy," commented Dr. Berenson. "Emerging safety results from CuraGen and NCI clinical trials that are evaluating belinostat and bortezomib have shown the combination to be generally well-tolerated. Therefore, we have initiated this Phase II study to allow relapsed and/or refractory multiple myeloma patients the ability to receive treatment with belinostat and bortezomib, and anticipate reporting preliminary results from the study by the end of the year," commented Frank Armstrong, M.D., President and Chief Executive Officer of CuraGen. " As data continues to be generated from our Phase II trials in ovarian cancer, colorectal cancer, and T-cell lymphomas, we look forward to presenting preliminary results during mid-2007, and remain on track to initiate a Phase III program during 2008 and advance belinostat towards registration."
In vitro studies published in the literature have shown that HDAC inhibitors and bortezomib, when combined, act synergistically through independent mechanisms leading to enhanced killing of cancer cells. During the 2006 ASH Annual Meeting, preclinical results evaluating belinostat in combination with bortezomib were presented in a poster entitled, "Effects of a Novel Histone Deacetylase Inhibitor, PXD101, When Used as Monotherapy or in Combination with Bortezomib on Tumor Growth in a Mouse Model of Human Multiple Myeloma." The data suggest that when mice bearing bortezomib-resistant human tumors were treated with the combination of belinostat and bortezomib, greater inhibition of both tumor growth and circulating human IgG levels were observed than when either drug was used alone, and the mice tolerated the combination well without obvious adverse effects. These results suggest that treatment with belinostat in combination with bortezomib may be an effective therapy for bortezomib-resistant multiple myeloma.
About Belinostat
Belinostat is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including 5-FU, carboplatin, paclitaxel, cis-retinoic acid, azacitidine and Velcade(R) (bortezomib) for Injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, colorectal, ovarian cancers, either alone or in combination with anti-cancer therapies. An oral formulation of belinostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors.
Safe HarborStatements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the expected benefits of belinostat in combination with Velcade(R) (bortezomib) for Injection, and the potential results of the clinical trials with belinostat designed to evaluate such benefits, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGen's stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE CuraGen Corporation
The Phase II clinical trial is being led by James Berenson, M.D., and will be conducted at multiple sites across the U.S. Up to 35 patients are planned for study enrollment with preliminary results anticipated by the end of 2007.
"Based on our preclinical studies that showed markedly increased anti-myeloma effects when belinostat was combined with bortezomib to treat a bortezomib-resistant myeloma in immunodeficient mice, we look forward to enrolling bortezomib-resistant multiple myeloma patients into this Phase II trial and determining whether the combination can provide clinical benefit to multiple myeloma patients that have failed, or who have relapsed on bortezomib therapy," commented Dr. Berenson. "Emerging safety results from CuraGen and NCI clinical trials that are evaluating belinostat and bortezomib have shown the combination to be generally well-tolerated. Therefore, we have initiated this Phase II study to allow relapsed and/or refractory multiple myeloma patients the ability to receive treatment with belinostat and bortezomib, and anticipate reporting preliminary results from the study by the end of the year," commented Frank Armstrong, M.D., President and Chief Executive Officer of CuraGen. " As data continues to be generated from our Phase II trials in ovarian cancer, colorectal cancer, and T-cell lymphomas, we look forward to presenting preliminary results during mid-2007, and remain on track to initiate a Phase III program during 2008 and advance belinostat towards registration."
In vitro studies published in the literature have shown that HDAC inhibitors and bortezomib, when combined, act synergistically through independent mechanisms leading to enhanced killing of cancer cells. During the 2006 ASH Annual Meeting, preclinical results evaluating belinostat in combination with bortezomib were presented in a poster entitled, "Effects of a Novel Histone Deacetylase Inhibitor, PXD101, When Used as Monotherapy or in Combination with Bortezomib on Tumor Growth in a Mouse Model of Human Multiple Myeloma." The data suggest that when mice bearing bortezomib-resistant human tumors were treated with the combination of belinostat and bortezomib, greater inhibition of both tumor growth and circulating human IgG levels were observed than when either drug was used alone, and the mice tolerated the combination well without obvious adverse effects. These results suggest that treatment with belinostat in combination with bortezomib may be an effective therapy for bortezomib-resistant multiple myeloma.
About Belinostat
Belinostat is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including 5-FU, carboplatin, paclitaxel, cis-retinoic acid, azacitidine and Velcade(R) (bortezomib) for Injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, colorectal, ovarian cancers, either alone or in combination with anti-cancer therapies. An oral formulation of belinostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors.
Safe HarborStatements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the expected benefits of belinostat in combination with Velcade(R) (bortezomib) for Injection, and the potential results of the clinical trials with belinostat designed to evaluate such benefits, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGen's drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGen's stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed with the Securities and Exchange Commission under the section "Risk Factors," as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company's actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE CuraGen Corporation
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