ROCKVILLE, Md.--(EON: Enhanced Online News)--GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that results of its Phase 1/2 clinical trial on its lead drug candidate GMI-1271 continued to show high rates of remission and favorable tolerability among study participants with acute myeloid leukemia (AML). The data are being shared today via a poster at the 58th American Society of Hematology (ASH) Annual Meeting and Expo in San Diego.
“We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for AML patients, and we are encouraged to now see potential for benefit in two distinct patient populations. We look forward to continuing to gather data in this ongoing trial.”
The company’s E-selectin antagonist, GMI-1271, showed significant progress in the Phase 1/2 clinical trial, in which clinicians are studying use of the drug candidate along with chemotherapy. For a total of 33 study participants with relapsed or refractory disease in one arm of the trial, the complete response (CR) rate was 45 percent. For 11 newly diagnosed study participants 60 or more years of age in the second arm of the trial, the CR rate was 73 percent. Thus, all study participants evaluated to date who have responded have had complete remissions; there have been no patients observed who responded with incomplete count recoveries (CRi). In addition, in elderly, newly diagnosed patients evaluated to date, the 60-day mortality rate was zero for those receiving intensive induction chemotherapy plus GMI-1271.
The results presented at the ASH meeting expand on data presented at the European Hematology Association 21st Congress in Copenhagen, Denmark, in June 2016.
“The Phase 2 data collected from the ongoing Phase 1/2 trial of GMI-2171 are very encouraging, demonstrating a high remission rate in both patient populations being treated. In addition, the combination of GMI-1271 and chemotherapy within the trial also seems to be extremely well tolerated," said Daniel J. DeAngelo, M.D., Ph.D., Director of Clinical and Translational Research, Adult Leukemia, in the Department of Medical Oncology at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School, who is serving as the clinical trial’s lead investigator. "We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for AML patients, and we are encouraged to now see potential for benefit in two distinct patient populations. We look forward to continuing to gather data in this ongoing trial."
Details of the ASH poster include:
Abstract #4049--A Phase I/II Study of GMI-1271, a Novel E-Selectin Antagonist, in Combination with Induction Chemotherapy in Relapsed/Refractory and Elderly Previously Untreated Acute Myeloid Leukemia; Results to Date. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session in the San Diego Convention Center, Hall G.
The poster is one of seven presentations on GlycoMimetics’ drug candidates being made at the ASH meeting. Data also was shared on results of pre-clinical and clinical research on the pan-selectin antagonist, rivipansel, which GlycoMimetics is developing in partnership with Pfizer, Inc.; other studies on GMI-1271; and the company’s dual E-selectin/CXCR4 antagonist, GMI-1359.
The meeting abstracts are available at ASH’s website.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics' most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics' wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial in multiple myeloma. GlycoMimetics has also recently initiated a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
This press release contains forward-looking statements regarding GlycoMimetics’ planned activities with respect to the clinical development of its drug candidate, GMI-1271. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for GlycoMimetics’ foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of GlycoMimetics’ drug candidates and other factors discussed in the “Risk Factors” section of GlycoMimetics’ Annual Report on Form 10-K that was filed with the U.S. Securities and Exchange Commission on February 29, 2016, and other filings GlycoMimetics makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent GlycoMimetics’ views as of the date hereof. GlycoMimetics anticipates that subsequent events and developments may cause its views to change. However, while GlycoMimetics may elect to update these forward-looking statements at some point in the future, GlycoMimetics specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing GlycoMimetics’ views as of any date subsequent to the date hereof.