Latest news from Datamonitor
pharmafile | January 15, 2008 | News story | Research and Development |
Competitive obtains license rights for breast cancer test
Competitive Technologies has signed a license and commercialization agreement for rights to the patented breast cancer diagnostic technology, Early Breastest.
According to Competitive Technologies, Early Breastest, a non-invasive technology, generates an analysis that detects angiogenesis, an early predictor of the possibility of cancer. The agreement provides for sharing of revenue derived from the technology.
John Nano, chairman, president and CEO of Competitive Technologies, said: "The Early Breastest technology is another part of our rapidly developing medical strategy, an example of a Competitive Technologies technology being at the forefront of the paradigm shift to treat individuals with integrative medicine, combining both traditional medicine and holistic medicine."
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FDA extends review period for Progenics and Wyeth's bowel drug
The FDA has extended by three months the action date for its review of the new drug application from Progenics Pharmaceuticals and Wyeth Pharmaceuticals for subcutaneous methylnaltrexone, which is being reviewed for the treatment of opioid-induced constipation in patients receiving palliative care.
The FDA's revised action date for methylnaltrexone is now April 30, 2008. The FDA, in its review of this new drug application (NDA), requested the results from a recently completed QT study of intravenous methylnaltrexone. This study, which was submitted to the FDA, reported that there was no evidence of an effect of methylnaltrexone on QT prolongation. The FDA recently notified Progenics that it needs the extended time to review fully this study.
Paul Maddon, founder, CEO and chief science officer, Progenics, said: "We, along with our collaborator, Wyeth, are confident in our subcutaneous methylnaltrexone submission. We are enthusiastic about the entire methylnaltrexone program and plan to submit an NDA for the intravenous formulation of methylnaltrexone for the management of post-operative ileus later this year."
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Transgene's cancer vaccine yields positive Phase II results
Transgene has reported promising preliminary data from the randomized, open-label and controlled Phase IIb trial evaluating its therapeutic vaccine TG4010 as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer.
This ongoing trial has been designed to assess the efficacy of TG4010 (MVA-MUC1-IL2) in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The patients in the trial had non-small cell lung cancer (NSCLC) expressing MUC1, either stage IIIB with effusion or stage IV, and had not received prior systemic treatment for their advanced disease. Half of the patients received the combination regimen (TG 4010 vaccine plus chemotherapy) and the other half of the patients received chemotherapy alone.
The trial confirmed the favorable safety profile of TG4010 when associated to chemotherapy: most adverse events observed so far were considered related to chemotherapy as well as to the underlying disease. Hematological toxicity was equivalent in both treatment groups.
Philippe Archinard, CEO of Transgene, said: "We report today encouraging trends on the preliminary results of our Phase IIb trial with TG4010 in NSCLC. We expect to present data during the second quarter of this year and final data by the fourth quarter of 2008."
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