Monday, April 09, 2007

New drug SNS-032

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced today the dosing of the first patient in a Phase 1 clinical trial of SNS-032 in patients with advanced B-cell malignancies. SNS-032, a novel, selective and potent small-molecule inhibitor of cyclin-dependent kinases (CDK) 2, 7 and 9, has been shown in preclinical and clinical studies to deplete cells of myeloid cell leukemia sequence 1, or MCL-1, a protein associated with cell survival, particularly in lymphomas and other B-lymphoid malignancies.

"Based on non-clinical and Phase 1 pharmacodynamic data of SNS-032 from our ongoing trial in patients with advanced solid tumors, we are eager to learn more about this promising anticancer compound in patients with hematological cancers," said Daniel C. Adelman, M.D., Senior Vice President, Research & Development at Sunesis. "SNS-032 targets both cell-cycle and transcriptional-regulation pathways crucial to cancer cell growth and survival. SNS-032 is selective and potent, with IC50s for CDK2, 7 and 9 in the low nanomolar range. We are enthusiastic about initiating clinical trials in B-cell malignancies as we have seen evidence that SNS-032's mechanism of action may be particularly well-suited to indications including multiple myeloma, chronic lymphocytic leukemia, and mantle-cell lymphoma."

This Phase 1 trial is designed to examine the safety and tolerability, as well as the preliminary anti-tumor activity, of SNS-032 in patients with B- cell malignancies. The trial is a dose-escalation study to establish a maximum-tolerated dose in this setting. The clinical trial will enroll approximately 30-40 patients at three centers in the United States. Sunesis hopes to obtain initial safety results from this study by year end.

SNS-032 is a novel targeted inhibitor of CDKs 2, 7 and 9, which are critical in the communication and relay of signals to promote cellular growth and function. CDK2 is involved in cellular proliferation by regulating the initiation of and progression through the DNA-synthesis phase of the cell cycle. CDK7 and CDK9 are involved in transcriptional regulation of certain proteins involved in cell survival. Inappropriate activity by these CDKs can lead to unregulated proliferation, avoidance of apoptosis and increased cell survival, all of which are hallmarks of cancer. By selectively targeting these CDKs, SNS-032 may halt both aberrant cell proliferation and induce apoptosis.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties. Sunesis may not actually achieve the plans, intentions or expectations contained in such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations contained in such forward-looking statements. Sunesis does not assume any obligation to update any such forward-looking statements.

Sunesis Pharmaceuticals, Inc. http://www.sunesis.com/

Wednesday, April 04, 2007

MMRF reports on Revlimid plus Dex trial

Today, the National Cancer Institute (NCI) and Celgene reported that, according to a preliminary analysis of a large, randomized Phase III trial in newly diagnosed multiple myeloma patients, REVLIMID (lenalidomide) in combination with low-dose dexamethasone was associated with improved survival when compared with a treatment regimen that included REVLIMID plus standard-dose dexamethasone. Specifically, after one year, the survival in the low-dose arm was 96 percent as compared to 86 in the standard-dose arm. In addition, there were fewer side effects associated with the REVLIMID and low-dose dexamethasone arm.

Detailed results from this trial will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in early June.

The trial was sponsored by the NCI, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).

While these results are incredibly exciting for myeloma patients, the MMRF reminds patients not to make any changes in their treatment regimen without speaking to their doctor first. This study was conducted in a newly diagnosed population, and it is important to understand that the results cannot necessarily be extrapolated to treatment for any other stage of the disease.

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