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pharmafile | December 18, 2007 | News story | Research and Development |
BioMS's multiple sclerosis trial receives positive review from DSMB
The Data Safety Monitoring Board has reviewed data from BioMS Medical's ongoing MAESTRO-03 US pivotal Phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis and recommended that the trial continue.
This was the first of several regularly scheduled reviews by the Data Safety Monitoring Board (DSMB) that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
The MAESTRO-03 trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the expanded disability status scale, in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all multiple sclerosis patients are HLA-DR2 and/or HLA-DR4 positive).
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BioWa and Lonza collaborate for new antibody technology
BioWa and Lonza have signed a strategic research collaboration agreement to combine BioWa's Potelligent technology with Lonza's GS gene expression system and CHOK1SV cell line.
Under the terms of the agreement, the parties intend to make the new Potelligent CHOK1SV cell line available for licensing and it will be offered as part of Lonza's development services in combination with Lonza's GS gene expression system. This is expected to generate a new technology platform to produce more potent antibodies with greatly enhanced antibody-dependent cellular cytotoxicity (ADCC) in a high-yield mammalian expression system for industry-wide use. The two companies will jointly market the new technology platform.
Masamichi Koike, president and CEO of BioWa, said: "We believe that combining both parties' technologies addresses a clear market need to improve production yields and can significantly aid the development of more effective targeted treatments for cancer and other life-threatening and debilitating diseases."
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Ceregene's drug shows reduction in Parkinson's symptoms
Ceregene has presented positive long-term follow-up data from a Phase I clinical trial of CERE-120 in 12 patients with advanced Parkinson's disease. Long-term follow up assessments at 18 and 24 months post treatment, suggest a sustained reduction in Parkinson's symptoms.
The Phase I trial was an open-label study conducted in 12 patients with advanced Parkinson's disease at two clinical trial sites. It was previously reported that an average of 36% reduction in Parkinson's symptoms was seen 12 months after CERE-120 administration. Of the 12 subjects treated, nine had shown a clinically meaningful reduction in symptoms at 12 months, and the mean improvement of these responders at 12 months was 46%.
The data showed that the eight evaluable responders exhibited a persistent mean improvement in symptoms of 52% at their longest time of follow-up (24 months for low-dose cohort and 18 months for high-dose cohort).
Jeffrey Ostrove, president and CEO of Ceregene, said: "We are pleased to see that the statistically significant improvement in motor symptoms seen in the Parkinson's patients 12 months after CERE-120 treatment appears to be persisting over longer time points. These positive clinical data offer further support for our recently enrolled multicenter Phase II trial for CERE-120 in the US as well as our plans to initiate another Phase II trial that will begin in the Q3 of 2008 which will be conducted in several European countries in collaboration with Genzyme."
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Chroma's leukemia drug meets Phase I goals
Chroma Therapeutics has reported positive data from a Phase I study with its oral, once-daily experimental cancer therapy CHR-2797 in the treatment of patients with acute myeloid leukemia, myelodysplastic syndromes and multiple myelomas who have failed on, or who are unsuitable for, chemotherapy.
The results demonstrated that out of 13 acute myeloid leukemia (AML) patients treated in this study, three showed a complete response and one further AML patient became transfusion-independent; one multiple myelomas (MM) patient (out of two treated in this study) remained in stable disease after six months of treatment with CHR-2797; and the drug was very well-tolerated during the study.
Chroma is currently assessing CHR-2797 in AML and myelodysplastic syndrome patients in the Phase II portion of this trial. This trial is now fully recruited and results are expected in the first half of 2008.
Ian Nicholson, CEO of Chroma, said: "We are very encouraged by the efficacy we have seen in this Phase I study and look forward to further exploring how patients with this debilitating disease might be treated with CHR-2797."
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