CHEMGENEX DRUG EFFICACY IN 2nd LEUKEMIA INDICATION
June 18th 2008 23:11
Tuesday June 17, 2008
Daily news on ASX-listed biotechnology companies
* ASX UP, BIOTECHS DOWN: OPTISCAN UP 19.5%, TISSUE THERAPIES DOWN 20%
* CHEMGENEX DRUG EFFICACY IN 2nd LEUKEMIA INDICATION; IP EGM
* VICTORIA, NEW ZEALAND CREATE $30m COMMERCIALIZATION FUND
* PHARMAXIS BRONCHITOL AVAILABLE VIA COMPASSION PROGRAM
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* FDA ALLOWS HALCYGEN’S IND APPLICATION
* WHO RENAMES CLINUVEL’S CUV1647 ‘AFAMELANOTIDE’
* FMR, FIDELITY DROPS 1% MORE OF COCHLEAR
* KARMELSONIX SAYS SOUND DETECTS BROCHO-DILATION
* CATHRX APPOINTS BOSTON SCIENTIFIC’S GED WALLACE PRESIDENT
* ASIC APPROVES CLINICAL CELL NAME CHANGE TO AVITA
* SUSPENDED PSIVIDA TO BE REPLACED BY PSIVIDA CORP
* AUSBIOTECH INAUGURATES BIO-BEERS
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CHEMGENEX
Chemgenex says its lead drug has shown efficacy in chronic myeloid leukemia patients who have failed therapy with two or more tyrosine kinase inhibitors.
Chemgenex said it was the first data on omacetaxine mepesuccinate (formerly known as Ceflatonin) in a phase II trial of patients with or without Bcr-Abl mutations.
Chemgenex said the data, presented at the European Haematology Association congress in Copenhagen, was separate from and complemented the findings from the phase II/III trial of omacetaxine mepesuccinate in chronic myeloid leukemia patients with the T315I mutation.
The announcement was made to the ASX yesterday (June 16) but Biotech Daily was unable to contact Chemgenex for clarification of the data prior to publication.
Of the 28 patients enrolled in the trial, the poster session data related to 12 evaluable patients: four in chronic phase, two in accelerated phase and six in blast phase.
Chemgenex said there were haematologic responses in all chronic and accelerated phase patients, with complete haematologic responses in three out of four chronic phase patients and both accelerated phase patients.
The company said the study showed cytogenetic responses in one of four chronic phase patients and one of two accelerated phase patients and two of six blast phase patients had haematological responses.
Chemgenex said omacetaxine therapy was associated with myelosuppression which was manageable and reversible.
Chemgenex chief executive officer Dr Greg Collier said the company was “delighted with this very positive early data from the multiple [tyrosine kinase inhibitors] resistance trial”.
Dr Collier said the poster at the American Society of Clinical Oncology conference in Chicago [see Biotech Daily; June 3, 2008] reported durable clinical responses in chronic myeloid leukemia patients with the T315I mutation.
He said the new data supported the belief that omacetaxine, acting through an independent mechanism of action, offered a new therapeutic alternative to the growing number of chronic myeloid leukemia patients who became resistant to tyrosine kinase inhibitor therapy.
Chemgenex said tyrosine kinase inhibitors such as imatinib, dasatinib and nilotinib target the Bcr-Abl protein and are the current approved therapies for chronic myeloid leukemia, but an increasing number of patients are developing resistance to these agents.
“The knowledge we are gaining from our two major clinical trials gives us confidence in the potential of omacetaxine to treat CML patients for whom there are few treatment options due to the limitations of tyrosine kinase inhibitor treatments,” said Dr. Collier.
He said the company was “on course” to begin filing a rolling new drug application to the US Food and Drug Administration in mid 2008, starting with the non-clinical section.
He said Chemgenex was on track to achieve its enrolment targets within the year and to complete the rolling new drug submission in mid 2009.
Separately, Chemgenex said that an extraordinary general meeting would be held to vote on the issue of 37,235,343 ordinary shares to Stragen International NV to acquire full control of the global intellectual property and commercialization rights of omacetaxine mepesuccinate (see Biotech Daily; June 10, 2008).
The meeting will be held at the offices of GBS Venture Partners at Level 5, 71 Collins Street, Melbourne on July 22, 2008 at 11am.
Chemgenex was up three cents or three percent to $1.03.
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