MESOBLAST BEGINS PHASE I/II US BONE MARROW TRANSPLANT TRIAL
November 8th 2008 02:43
Wednesday November 5, 2008
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MESOBLAST
Mesoblast has begun a phase I/II clinical trial in the US of up to 30 patients with haematologic malignancies undergoing bone marrow transplantation.
Mesoblast said the clinical trial will evaluate the safety and effectiveness of allogeneic or off-the-shelf mesenchymal precursor cells to increase the rate and speed of bone marrow engraftment following transplantation of haematopoietic stem and progenitor cells.
The company said the trial followed US Food and Drug Administration clearance of an investigational new drug submission and ethics approval by the institutional review board at the University of Texas MD Anderson Cancer Center in Houston.
The trial will be funded through a grant from the US National Institutes of Health.
The trial's principal investigator is Prof Elizabeth J Shpall.
Mesoblast said the mesenchymal precursor cells product used in the trial would be developed under the FDA orphan drug designation granted to Mesoblast's US-based sister company Angioblast Systems Inc for treating patients with haematologic malignancies requiring increased haematopoietic stem and progenitor cell production.
The company said orphan drug designation was for conditions affecting up to 200,000 patients a year in the US and allowed for an accelerated review process by the FDA, seven-year market exclusivity in the US on obtaining authorization, tax benefits and exemption from user fees.
For patients with haematologic malignancies, transplantation of haematopoietic stem and progenitor cells from the bone marrow of a healthy donor is a life-saving procedure as they rebuild bone marrow damaged and destroyed by cancer treatments, Mesoblast said.
About 30 percentof patients who could benefit from such a procedure have a genetically matched sibling and for the rest receiving a bone marrow transplant from an unrelated donor carries a high risk of potentially fatal graft-versus-host disease.
Mesoblast said umbilical cord blood was a preferred source of haematopoietic stem and progenitor cells because it has a reduced likelihood of causing graft-versus-host disease compared with bone marrow from an unrelated adult.
“However, the major limitation to cord blood use in adults is the limited number of haematopoietic stem and progenitor cells compared with bone marrow obtained from an adult,” the company said.
“This often results in delay or inability to achieve satisfactory bone marrow reconstitution, resulting in increased rate of graft failure, infections, bleeding and death,” Mesoblast said.
Mesoblast said Prof Shpall and her colleagues at the MD Anderson Cancer Center had been developing procedures for the ex-vivo expansion of cord blood for the past 10 years.
In a collaborative study with Angioblast, Prof Shpall showed that the proprietary allogeneic mesenchymal precursor cells (MPCs) could be used “to rapidly and significantly expand the number of haematopoietic progenitor cells present in cord blood”.
“The most promising results we have generated to date are with Angioblast's proprietary off-the-shelf MPCs,” Prof Shpall said.
“Haematopoietic progenitor cells present in cord blood can be expanded by over 20-fold following simple culture with the company's proprietary MPCs,” Prof Shpall said.
“Angioblast's off-the-shelf MPCs provide a very reproducible and standardized product for these gravely ill patients,” she said.
“As important, since time is critical in these procedures, these allogeneic MPCs are available for immediate use,” Prof Shpall said.
“We hope that these advantages will translate into faster and more effective bone marrow engraftment and improved patient outcomes,” she said.
Mesoblast climbed five cents or five percent to $1.05.
SIZE=2]To read all these articles in full, subscribe to Biotech Daily at the link above or at www.biotechdaily.com.au [/SIZE]
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