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pharmafile | July 2, 2007 | News story | Research and Development |Â Â Â
Biovest reports encouraging interim results for cancer vaccine
Biovest International, a majority-owned subsidiary of Accentia Biopharmaceuticals, has revealed positive interim data from its phase III clinical trial of BiovaxID for non-Hodgkin's lymphoma.
The interim blinded data covers 122 patients who have received either BiovaxID or control vaccine. The trial showed that approximately 40% of the evaluable patients in the study remained disease-free from 40 months to almost 70 months.
BiovaxID is an anticancer vaccine undergoing testing in a fast-tracked pivotal phase III clinical trial for a target indication of non-Hodgkin's lymphoma. BiovaxID is a personalised, patient-specific vaccine designed to stimulate the patient's own immune system to recognise and destroy residual cancerous B-cells that remain after the patient has undergone chemotherapy.
Unlike many other approaches to treating non-Hodgkin's lymphoma, BiovaxID is designed to target only cancerous B-cells. The BiovaxID phase III clinical trial is being conducted at 14 US oncology centers and eight centres in Russia.
Applications for accelerated conditional approval of BiovaxID are planned to be submitted to both the FDA and EMEA by mid-2008. If conditionally approved, BiovaxID could become commercially available in early 2009.
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Millennium reports high survival rates for patients on Velcade
Millennium Pharmaceuticals said that four clinical trials of Velcade-based therapies showed consistently high survival rates in newly diagnosed multiple myeloma patients.
A study evaluating Velcade, melphalan and prednisone demonstrated a complete response (CR) rate of 43%, the strongest rate ever reported for a melphalan-prednisone combination therapy, Millennium said. At 38 months, 85% of patients were alive. This is the highest reported three-year survival rate in the front-line treatment setting, the company said.
In another trial, Velcade, adriamycin and dexamethasone showed a CR rate of 29% prior to stem cell transplantation (SCT), which further improved to 57% following SCT. At one year, 100% of patients were alive, and at two years, 95% of patients were alive – the highest reported two-year survival rate in the front-line treatment setting.
A Velcade, Doxil and dexamethasone combination showed a CR rate of 43% prior to SCT, which increased to 65% following SCT. At 16 months, 100% of patients were alive. In the final trial, Velcade, lenalidomide and dexamethasone showed an overall response rate of 100%, including a CR rate of 20%.
In the US, Velcade is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy and for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
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Pfizer starts pivotal study for colorectal cancer drug
Pfizer has started a phase III clinical trial to evaluate the safety and efficacy of sunitinib malate, in combination with a standard chemotherapy regimen, in patients with metastatic colorectal cancer.
In addition, new data from a phase I study showed that sunitinib malate is active and generally well-tolerated in combination with a standard chemotherapy regimen, Folfiri, in previously untreated patients with metastatic colorectal cancer (mCRC). This data supports further evaluation of sunitinib malate in mCRC in a phase III program, according to Pfizer.
A multi-national phase III study is currently open and enrolling in Europe, Canada, Asia and South America and will include more than 700 patients.
Sunitinib malate is a multi-kinase inhibitor which works by inhibiting angiogenesis, the process by which tumours acquire blood vessels bringing oxygen and nutrients needed for growth, and proliferation, the process by which cells multiply.
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Speedel reports positive phase II results for hypertension drug
Swiss biopharmaceutical company Speedel has reported positive results for its hypertension drug in a phase II clinical trial.
Based on the results, which demonstrated strong efficacy and good tolerability, the company says it will continue developing SPP635 in phase II in a special population of diabetic patients with mild-to-moderate hypertension.
This compound is the first of a next generation of renin inhibitors following Speedel's lead product SPP100, which is partnered with Novartis and recently obtained US marketing approval from the FDA.
The trial had a double-blind, placebo-controlled, randomised, parallel design and evaluated patients treated with a single dosage level of SPP635 once-daily for four weeks. It studied the safety and efficacy of SPP635 in 35 male and female patients (20 patients receiving SPP635 and 15 receiving placebo) with mild-to-moderate hypertension by measuring office and ambulatory blood pressure.
According to Speedel, SPP635 was safe and well tolerated over the four-week period, and significantly reduced systolic and diastolic blood pressure.
The company expects to conclude the whole phase II test series in the second half of 2008.
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Stem cell breakthrough could accelerate research
Researchers have discovered a new type of embryonic stem cell in mice and rats that is the closest counterpart yet to human embryonic stem cells, bringing scientists closer to realising the potential of stem cells in treatments for disease.
The scientists from Oxford University, in collaboration with the US National Institutes of Health, said that the cells are expected to serve as an improved model for human stem cells in studies of regeneration, disease pathology and basic stem cell biology.
Up until now, embryonic stem cells derived in humans and mice had looked different and behaved differently. In the new research, the team found that when mouse stem cells were derived from slightly older mouse embryos, they looked very similar to human embryonic stem cells under the microscope and had many of the same properties. Importantly, these new mouse stem cells could be maintained using the same growth factors as those used in the culture of human embryonic stem cells.
The discovery is likely to accelerate understanding of stem cell development and help the derivation of stem cells in other species, including livestock and disease-prone mice used in research, thereby providing better models for researchers involved in stem cell research.
The Oxford paper was published simultaneously with a paper from a team at Cambridge demonstrating independently the same findings.
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