Clinical Data Supporting Development of ChemGenex's Ceflatonin(R) in Imatinib-Resistant CML Published in Cancer.MELBOURNE, Australia & MENLO PARK, Calif. -- ChemGenex Pharmaceuticals (ASX ASX See: Australian Stock Exchange : CXS CXS Coherent X-Ray Scattering ) (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CXSP) announced today that positive clinical results supporting the development of Ceflatonin([R]) in patients with chronic myeloid leukemia (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ), including patients who had failed treatment with Gleevec([R]) (imatinib mesylate) have been published in Cancer (the journal of the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, ). Of the five patients who received homoharringtonine (HHT HHT Hereditary Hemorrhagic Telangiectasia (Osler-Rendu-Weber disease) HHT Headquarters Troop HHT Hand-Held Terminal HHT House Hunting Trip HHT Heinrich Hertz Telescope HHT Headquarters & Headquarters Troop ) (Ceflatonin([R])) at the highest explored dose and were evaluable for response to therapy, all achieved a complete hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. response, including those with the Bcr-Abl kinase domain mutations that confer Gleevec([R]) resistance. The Phase 1/2 safety and efficacy study of the use of subcutaneous HHT included a total of 17 patients (11 in the Phase 1 portion of the study, and 6 in Phase 2) and was conducted by Dr. Jorge Cortes and colleagues at the M.D. Anderson Cancer Center in Houston, Texas and the National Cancer Institute (NCI See Liberate. ). ChemGenex is currently conducting a Phase 2/3 registration-directed study evaluating the use of Ceflatonin([R]) in CML patients who have the T315I Bcr-Abl point mutation that is associated with resistance to imatinib and other tyrosine kinase inhibitors. The key results described in the publication were: * Homoharringtonine was well tolerated when administered subcutaneously into CML patients at the same dose levels as intravenously administered drug (at dose levels that had previously been shown to be active in CML patients); * In the phase 2 portion of the study six patients were treated at the maximal tolerated dose (MTD), HHT 1.25 mg/m2subcutaneously twice daily, and five of these patients were evaluable for response to treatment; * Complete hematological remission (CHR CHR canine hypoxic rhabdomyolysis. ) was obtained in all five evaluable patients; one patient showed complete cytogenic response and three patients also showed partial cytogenic responses; * The two patients who entered the study with Bcr-Abl kinase domain mutations showed a cytogenic response, and, at the end of treatment, the kinase domain mutations were undetectable in both. * The authors noted that all patients developed some hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. toxicities (neutropenia, thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. and anemia) and that non-hematologic toxicity was mild and manageable. Three patients had their HHT dose reduced due to prolonged neutropenia, but no patients discontinued therapy. The authors concluded that "Subcutaneous HHT is well tolerated and may have clinical activity in patients with CML after imatinib failure. Importantly, its clinical benefit seems to be independent of the presence of mutations in the Bcr-Abl tyrosine kinase domain, thus offering a potential therapeutic alternative for this patient population." ChemGenex is seeking to confirm the authors' conclusions through its international registration-directed study in CML patients who are refractory to Gleevec([R]) (imatinib mesylate) and who have the T315I Bcr-Abl kinase point mutation. "The results described in this publication provide strong support for our Ceflatonin([R]) development program," said Greg Collier, Ph.D., ChemGenex's Managing Director and Chief Executive Officer. "This published study was conducted using virtually the same treatment regimen and product presentation as we are using in our ongoing registration-directed study (CML-202). Importantly, the results show that Ceflatonin([R]) provides clinical benefit in previously treated patients, including patients who have Bcr-Abl kinase mutations." "As we have previously advised," Dr. Collier noted, "the CML-202 study is currently enrolling patients in North America and Europe, and we expect to complete enrollment in the second half of 2007." About Ceflatonin([R]) Ceflatonin([R]) (HHT) is a potent inducer inducer /in·duc·er/ (in-dldbomacs´er) a molecule that causes a cell or organism to accelerate synthesis of an enzyme or sequence of enzymes in response to a developmental signal. in·duc·er n. of apoptosis (programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the ) in myeloid myeloid /my·eloid/ (mi´e-loid) 1. medullary; pertaining to, derived from, or resembling bone marrow or the spinal cord. 2. having the appearance of myelocytes, but not derived from bone marrow. cells and inhibits angiogenesis (blood vessel formation). In phase 2 studies, Ceflatonin([R]) has demonstrated clinical activity in patients with CML, both as a single agent and in combination with other chemotherapeutic drugs. ChemGenex is developing Ceflatonin([R]) for the treatment of CML, and pilot studies are underway in myelodysplastic syndrome (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ) and in acute myeloid leukemia (AML AML - A Manufacturing Language ). Ceflatonin([R]) has a different mechanism of action than tyrosine kinase inhibitors (TKI's), and ongoing and proposed clinical studies seek to determine: 1. Efficacy in treatment of CML patients who have developed resistance to tyrosine kinase inhibitor (TKI) therapy due to development of the T315I Bcr-Abl kinase domain point mutation. The T315I Bcr-Abl mutation, which develops in some CML patients treated with TKI's, is associated with resistance to Gleevec([R]) and Sprycel([R]); 2. Efficacy in CML patients who have failed therapy with two tyrosine kinase inhibitors, e.g., Gleevec([R]) and Sprycel([R]) and; 3. Efficacy as combination therapy with Gleevec([R]), for the treatment of residual disease and to prolong Gleevec([R]) sensitivity in CML patients who have developed resistance to Gleevec([R]). Ceflatonin([R]) is not approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications. Ceflatonin([R]) is a registered trademark of ChemGenex Pharmaceuticals Limited. Gleevec([R])/Glivec([R])is a registered trademark of Novartis AG. Sprycel([R]) is a registered trademark of the Bristol-Myers Squibb Company. About ChemGenex Pharmaceuticals Limited (www.chemgenex.com) ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing therapeutics in the areas of oncology, diabetes, obesity, and depression. ChemGenex harnesses the power of genomics for target discovery and validation, and in clinical trials to develop more individualized therapeutic outcomes. ChemGenex's lead compound, Ceflatonin([R]), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML) and Quinamed([R]) is in phase 2 clinical development for prostate, breast and ovarian cancers. The company has a significant portfolio of anti-cancer, diabetes, obesity and depression programs, several of which have been partnered with international pharmaceutical companies. ChemGenex currently trades on the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. under the symbol "CXS" and on NASDAQ under the symbol "CXSP". Safe Harbor Statement Certain statements made herein that use the words "estimate", "project", "intend", "expect", "believe", and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company's technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company's technology, the market for the company's products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management's current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected. |
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