Spexis announces positive renal impairment clinical trial results with balixafortide
ALLSCHWIL, Switzerland, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced the results of a Phase 1 clinical trial with balixafortide (“BLX”), a potent, specific and highly selective macrocycle inhibitor of CXCR4. This study was undertaken to investigate whether dosing of BLX needs to be adjusted in patients with renal impairment as part of any future market approval submission.
The Phase 1 trial was designed to investigate the pharmacokinetics, safety and tolerability of BLX in subjects with mild (n=8), moderate (n=8), or severe (n=7) renal impairment compared to a control group (n=8) with normal renal function. Each person received a single 2-hour intravenous infusion at the previously studied clinical dose of 5.5 mg/kg BLX.
In this trial, BLX was shown to be safe and well tolerated in all subjects, with only transient and mild-to-moderate manageable hypersensitivity-like events known to occur during initial drug infusion with CXCR4 inhibitors that were independent of renal impairment grade. With increasing grades of renal impairment, BLX administration resulted in more and longer-persisting circulating white blood cell levels, including neutrophils. Previous clinical trials with BLX at lower doses had demonstrated the ability to stimulate stem cell mobilization in healthy volunteers and in patients with advanced hematologic malignancies. The data from this renal impairment trial indicate that BLX doses substantially higher than 5.5 mg/kg, the highest dose previously tested, can potentially be safely administered, stimulate higher levels of stem cell mobilization and for longer durations well beyond 24 hours.
“The safety and pharmacokinetic findings in the renal impairment trial with balixafortide and data from previous nonclinical toxicity studies support potential dose levels of up to 16.5 mg/kg, which is threefold higher than previously studied dose levels. In addition, we are encouraged by the increases we observed in white blood cells and neutrophils, which support further clinical testing of balixafortide at higher dosing levels to assess its full potential in generating stem cell mobilization. Based on the results observed to date, we believe balixafortide may have the potential to generate more powerful stem cell mobilization than previously observed with CXCR4 inhibitors,” said Juergen Froehlich, MD, Chief Medical Officer of Spexis. “Patients with hematologic malignancies worldwide need additional highly effective treatment options in preparing for hematopoietic stem cell transplantation after treatment with high-dose chemotherapy. We look forward to further investigating the role balixafortide could play in this important area of cancer treatment.”
Increase of functional stem cell, also called mobilization, is an important prerequisite to the collection and transplantation of bone marrow cells in patients with hematologic malignancies. CXCR4 inhibition has been shown to be a viable approach to increase the yield of collecting stem cells from peripheral blood.1 Hematologic malignancies occur due to uncontrolled growth of blood cells and lymphoid tissues and account for 6.5 % of cancers worldwide and approximately 9 % in Europe and the United States.2
About Balixafortide (“BLX”)
About Spexis’ Macrocycle Platform: