- Poster presented at the 2015 American Society of Clinical Oncology Annual Meeting -
SALT LAKE CITY--(BUSINESS WIRE)--Tolero Pharmaceuticals, Inc., a clinical-stage company developing treatments for serious hematological diseases, and Eutropics, Inc. (Cambridge, MA), a clinical diagnostic company, announced today the details of a biomarker-driven clinical development strategy for the CDK9 inhibitor, alvocidib, in patients with acute myeloid leukemia (AML). The analysis of clinical samples utilized Eutropics’ novel companion diagnostic platform, PraediCare Dx, to analyze bone marrow to determine if a single marker was enriched in patients who went on to achieve a complete remission after treatment with an alvocidib-containing regimen. The results from this analysis demonstrated that patients whose bone marrow samples had high activity levels of the pro-apoptotic protein, NOXA, were most likely to attain a complete remission from the alvocidib regimen. These findings were presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting.
“The PraediCare Dx platform demonstrated strong predictive power in this analysis and further supports our goals to make sure patients are matched to the right therapies that will benefit them the most”
The analysis of NOXA sensitivity may be used to further support the development of alvocidib, which has demonstrated compelling clinical activity in patients with AML when combined with standard chemotherapy agents, such as cytarabine and mitoxantrone. The companies plan to validate the patient enrichment strategy of using Eutropics’ companion diagnostic test as a way to identify patients with a very high probability of attaining a complete remission when treated with alvocidib-based regimens.
“High NOXA sensitivity in these patients samples strongly correlated with the patient achieving a complete remission on alvocidib-based treatment. This analysis may provide a powerful tool to ensure that patients treated with alvocidib have a greatly increased potential to achieve a complete remission and potentially enjoy a positive long-term outcome,” said David J. Bearss, PhD, CEO of Tolero. “Furthermore, the link of NOXA sensitivity to the function of MCL-1 further substantiates the clinical mechanism of action of alvocidib through CDK9-dependent suppression of MCL-1 expression, a major signaling pathway in the biology of AML.”
“The PraediCare Dx platform demonstrated strong predictive power in this analysis and further supports our goals to make sure patients are matched to the right therapies that will benefit them the most,” said Michael Cardone, PhD, CEO of Eutropics.
About Alvocidib
Alvocidib is a potent small molecule inhibitor of cyclin-dependent kinases (CDKs) in development as a combination therapy for frontline and relapsed/refractory AML. CDKs are regulatory proteins that are critical to cellular replication and regulation of gene expression. Given the key role CDK de-regulation plays in unchecked cell division, proliferation and expression of cancer-associated genes, CDKs are an attractive target for the treatment of various cancers.
About Eutropics
Eutropics is a clinical diagnostics company that is utilizing a novel approach for guiding the use of established and experimental therapeutics, enabling the delivery of personalized medicines to patients suffering from cancer. Eutropics' PraediCare Dx platform delivers medically useful CLIA certified in vitro diagnostic assays. Eutropics (www.eutropics.com) is a privately held company located in Cambridge, MA.
About Tolero
Tolero Pharmaceuticals is a clinical stage biopharmaceutical company developing treatments to improve and extend the lives of patients with serious oncological and hematological diseases. Our diverse pipeline targets important biological drivers of blood disorders to treat leukemias and anemia as well as important targets of drug resistance and transcriptional control.
Contacts
Tolero Pharmaceuticals, Inc.
Joe Nilson, 801-285-6003
bizdev@toleropharma.com
