PBI-1402 Improves Numbers of Reticulocytes as well as Burst-Forming Unit-Erythroid Cells
Mar 11, 2005 - 7:25:00 AM
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"The effect of a PBI-1402 and erythropoietin combination observed on human bone marrow during in vitro experiments is of great interest and will be further examined during clinical trials in anemic patients "
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By Akanksha, Pharmacology Correspondent,
[RxPG] ProMetic Life Sciences Inc. announced additional positive data resulting from further analysis following a Phase I clinical study with PBI-1402. The analysis, performed by two external firms, confirms that the drug, taken orally, not only increases the absolute and relative number of reticulocytes in blood but also the number of burst-forming unit-erythroid cells (BFU-E), the precursors of reticulocytes. This strengthens the expected use of PBI-1402 for the treatment of anemia, a market expected to reach US$9.3 billion in 2005, in the United States alone.
The increased number of reticulocytes observed at day 21 of treatment in cohort 5 was statistically significant from the placebo group (p (less than) 0.0001).
"The safety profile demonstrated by PBI-1402 during this trial suggests that the drug will be well tolerated during chronic therapy," said Dr. Christopher Penney, Chief Scientific Officer and Vice- President of Research and Development, Therapeutics. "Obtaining early evidence of biological activity in a Phase I trial is a major bonus," added Dr. Penney.
"This new drug could play a major role in the treatment of anemia induced by chemotherapy and renal dialysis," said Dr. Denis Claude Roy, Hematologist and Director, Cellular Therapy Laboratory at Maisonneuve-Rosemont Hospital, and principal investigator of this study. "The follow-up trials will be designed to demonstrate clinical efficacy of PBI-1402 alone or in combination with erythropoietin."
PBI-1402 leads the way in novel drug discovery that could potentially be of help to further increase the efficacy of existing anemia treatments such as erythropoietin, while reducing the cost to the healthcare system. "The effect of a PBI-1402 and erythropoietin combination observed on human bone marrow during in vitro experiments is of great interest and will be further examined during clinical trials in anemic patients," stated Dr. Lyne Gagnon, Director of Biology, Therapeutics.
More on the next clinical trials
We cannot conclude from these preliminary results whether the maximal effect was obtained with PBI-1402. ProMetic has already received authorization from Heath Canada to perform two additional cohorts at higher doses and for a longer treatment period in healthy volunteers.
The data generated with these two cohorts will provide complementary information with regards to the effect of the duration of treatment on the formation of reticulocytes and on the dose- response curve.
ProMetic believes it is possible that the dose required to obtain a similar increase in the reticulocytes count in anemic patients will be lower than that required for healthy volunteers. A study where PBI-1402 will be administered to anemic patients undergoing chemotherapy is scheduled to start in the second quarter of this year, in parallel with the completion of the two additional cohorts.
Chemotherapy for cancer patients, dialysis and zidovudine treatment for HIV patients are leading factors that can cause anemia. Generally, these factors induce the destruction or inhibition of production of red blood cells, leading to the need for supportive care for patients such as treatment with erythropoietin. Erythropoietin induces the formation and the maturation of red blood cells in the bone marrow.
The randomized, double blind, dose-escalating Phase I study included five cohorts of eight subjects randomized to receive PBI-1402 and placebo. The objectives of the study were to gain early evidence of the efficacy and to confirm the safety and tolerability of PBI-1402 in healthy volunteers.
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Additional information about the news article
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ProMetic Life Sciences Inc. (TSX: PLI.SV) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Enabling Technology, the Mimetic Ligand(TM). This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in Therapeutic Drug Development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of inflammation and cancer. Its drug discovery platform is focussed on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D and manufacturing facilities in the UK and business development activities in the US, Europe, Asia and MENA countries (Middle East and North Africa).
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