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Bio-Path Holdings’ Initial Phase I Data In Leukemia Clinical Trial Demonstrates That Its Neutral Lipid Delivery Technology Antisense Drug BP-100-1.01 (Liposomal Grb-2) Is Well Tolerated With Activity Seen At Low Starting Dose

Bio-Path Holdings, Inc. (OTC BB: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, announced that results from Cohort 1 of the Phase I clinical trial of its lead product candidate, BP-100-1.01 (Liposomal Grb-2), were disclosed yesterday in a poster presentation at the 53 rd Annual Meeting of the American Society of Hematology (ASH) held in San Diego, California. BP-100-1.01 is a novel, systemic liposomal antisense treatment for blood cancers including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The trial is being conducted at The University of Texas MD Anderson Cancer Center. The drug was well tolerated with no treatment-related serious adverse events reported and data suggests some possible anti-leukemia activity at a low starting dose.

In a poster presentation entitled, “Safety, Pharmacokinetics, and Efficacy of BP-100-1.01 (L-Grb-2 Antisense Oligonucleotide) in Patients with Refractory or Relapsed Acute Myeloid Leukemia (AML), Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), and Myelodysplastic Syndrome (MDS),” Jorge Cortes, M.D., Professor at the MD Anderson Cancer Center, lead author and Principal Investigator for the clinical trial, reported that preliminary results suggest that BP-100-1.01 at a dose of 5 mg/m 2 is well tolerated and there is suggestion of some possible anti-leukemia activity. Lab parameters for the six evaluable patients show each of these patients experienced transient reductions for blasts and bone marrow results. Two patients had transient improvement and/or stable disease and received a total of five cycles each. Two patients also had transient improvements in leukemia cutis lesions. In addition to the six evaluable patients, one patient with CML blast phase who had failed all available tyrosine kinase inhibitors and other experimental options showed a significant reduction in blasts from 81 percent to four percent. Unfortunately, this patient discontinued study treatment due to progression in central nervous system disorder, unrelated to drug, and had to discontinue therapy. The study continues to accrue patients and Cohort 2 is currently open with dosing at 10 mg/m 2.

In commenting on the initial results from the trial, Dr. Cortes said, “BP-100-1.01 has a novel mechanism of action with potential to become an important therapy for patients with CML and other leukemias. The early data, with some suggestions of activity at very low doses, are very encouraging.”

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