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The goal of this clinical research study is to find the highest safe dose of a liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide (L-Grb2 AS) that can be given as treatment for patients with Philadelphia Chromosome positive CML, AML, CLL and MDS. The trade name of this drug is BP-100-1.01. The response of the leukemia to this treatment will also be studied. In addition, the time needed for the body to process this drug will be evaluated.
The Philadelphia Chromosome is an unusual genetic trait found in 90-95% of patients with CML. The protein created by this unusual trait causes normal cells within the body to become cancer cells, and then causes these cells to grow and divide at a rapid rate. Researchers think that the protein Growth Factor Receptor Bound Protein-2 (Grb-2) is necessary to the growth of these cancerous cells. The drug under study may be able to prevent the cells from making this protein. Researchers hope that without this protein, the leukemia cells will die.
Between 18 and 30 patients are expected to be enrolled on this study. Between 3 and 6 patients will be treated at each dose level. Each new group will be treated at a dose higher than the previous group. If the highest safe dose of the study drug is not found after the completion of this study, additional doses or another study may be considered.
The study drug is an antisense molecule complementary to the mRNA (messenger RNA) code for the cell's expression of the protein Grb-2. The study drug is incorporated into lipid (fat) particles known as liposomes. This incorporation process is part of the manufacturing procedure and is done before the drug is administered. The liposomes (which carry the study drug) will then be injected into a vein twice a week for at least 28 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Pharmacokinetics of L-Grb-2 in Treating CML, AML, CLL and MDS
BP-100-1.01 (Liposomal Grb-2)
M. D. Anderson Cancer Center
Bio-Path Holdings, Inc.
Published on BioPortfolio: 2014-08-27T03:12:22-0400
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