- No Dose-Limiting Toxicities Observed in Lymphoma and Acute Myeloid Leukemia Patients at All Dose Levels Studied To-Date -
- Early Indications of Efficacy in Assessable Patients at Multiple Dose Levels -
In the AML group, patients treated at the 22.5 mg dose level experienced no dose limiting toxicities, including no grade 3/4 neutropenias (an abnormally low count of neutrophils, a type of white blood cell). The AML group has entered the last planned dose level of 30 mg. As previously reported, significant anti-leukemic effects (i.e., greater or equal to 50 percent decrease in bone marrow blasts following GFH009 monotherapy) have been observed in AML patients treated sufficiently long enough to assess efficacy at previous dose levels.
In the lymphoma group, the 15 mg dose level cohort has completed enrollment. Safety assessments for this cohort are currently underway. In the previous 9 mg dose level cohort, one patient, with peripheral T-cell lymphoma, an aggressive type of lymphoma that develops from mature-stage T-cells and natural killer (NK) cells who was refractory to three prior lines of therapy, demonstrated a partial response as seen on a computerized tomography (CT) scan.
“We continue to see positive results in our clinical efforts for GFH009, especially in assessing the safety in patients with lymphoma and AML,” said
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This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the clinical data for GFH009, plans for further development of GFH009, and the potential for GFH009 as a drug development candidate. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the COVID-19 pandemic and its impact on the Company’s clinical plans and business strategy, risks and uncertainties associated with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
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