FDA WARNING PROMPTS MESOBLAST PIVOTAL SPINAL FUSION TRIAL
August 22nd 2008 22:40
Thursday August 21, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: POLARTECHNICS UP 9%, NOVOGEN DOWN 6%
* FDA WARNING PROMPTS MESOBLAST PIVOTAL SPINAL FUSION TRIAL
* HEARTWARE IMPLANTS 1st US HEART PUMP; BARCLAYS TAKES 6%
* PROTEOME FOCUSES ON DIAGNOSTICS, EXITS THERAPEUTICS
* GBS VENTURES INCREASES TO 22% OF PORTLAND ORTHOPAEDIC
* AUSBIOTECH MEETS IN GEELONG
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MESOBLAST
Mesoblast says a US Food and Drug Administration warning on its main competitor’s technology will accelerate its cervical spine fusion application process.
Mesoblast said in a media release to the ASX that the FDA provided a notification “alerting healthcare practitioners to reports of life-threatening complications associated with recombinant human bone morphogenetic protein (rhBMP) when used in the cervical spine”.
The July 1, 2008 warning is at Really Long Link
Mesoblast executive director Prof Silviu Itescu says the FDA warning, along with a Monash University trial of cervical fusion in sheep completed last week and early data from a phase II human clinical trial for lumbar spine fusion, has accelerated plans to seek FDA for approval a pivotal phase II/III cervical spine human trial for his company’s allogeneic (off-the-shelf) adult stem cells.
Prof Itescu told Biotech Daily that Medtronic had $US800 million sales of bone morphogenetic protein “of which the vast majority is for spinal fusion”.
He said spinal fusion was 40 percent of off-label use for bone morphogenetic protein.
Prof Itescu said the material was used to encourage bone growth and was not present in his company’s stem cell material.
The FDA describes the response to the protein as “life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine”.
Symptoms include “difficulty breathing or swallowing, or swelling of the neck, tongue, mouth, throat and shoulders or upper chest area …and [patients] need to seek medical attention immediately at the first sign of an airway complication”.
“The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use,” the FDA said.
Prof Itescu said Medtronic was the “number one competitor in the market” and although the safety results from the human lumbar spinal fusion trial were based on very low numbers there were no adverse events and Mesoblast was requesting the FDA expand approval for the trial from single centre to up to 10 sites in a multicentre trial.
Along with the cervical spine fusion safety data in sheep “we can take that data to the FDA now for a cervical spine phase II trial” Prof Itescu told Biotech Daily.
In its media release Mesoblast said its allogeneic cell therapy product was safe and highly effective in preclinical trials for inter-body fusion of the cervical spine in the neck.
“These results provide Mesoblast with a major clinical and commercial opportunity in light of the recent notification by the [FDA],” the company said.
Mesoblast quoted the FDA recommending “that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies”.
“Given the limited treatment options available for patients in need of cervical fusion, Mesoblast believes that this clinical indication may provide an accelerated path to regulatory market approval of its product,” the company said.
Mesoblast said the Monash University trial of 24 ewes showed its allogeneic stem cell therapy in cervical fusion to be safe and indicated “superior fusion outcomes”.
“Significantly, no cell-related adverse events were noted at any time throughout the study,” Mesoblast said. “Groups receiving either dose of Mesoblast's allogeneic cells had earlier and more robust fusion than the other groups.”
“In view of the FDA notification concerning life threatening complications of rhBMP in cervical fusion, we are encouraged that the profile of our allogeneic cells in the cervical space may translate into a safe and effective clinical alternative,” Prof Itescu said.
Mesoblast was up 1.5 cents or 1.17 percent to $1.295.
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