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April 16, 2014
08:12 EDTCBLICleveland BioLabs announces successful completion of Phase 1 study of CBL0102
Cleveland BioLabs announced the achievement of all objectives in a Phase 1 clinical trial of CBL0102, or quinacrine, an orally administered small molecule. The study was performed in patients with advanced cancers for which no standard care exists or which had become resistant to conventional therapies. All patients had tumors involving the liver. CBL0102 is being developed by Incuron, a joint venture between Bioprocess Capital Ventures and Cleveland BioLabs. The primary objective of the study was to evaluate for a maximum tolerated dose and dose-limiting toxicities of CBL0102 in patients with advanced cancers. Secondary objectives were to characterize the drug's safety and to profile its pharmacokinetics. The study also assessed for preliminary evidence of CBL0102 antitumor activity. In particular, the study was designed to explore potential effects related to CBL0102's high relative biodistribution into the liver and therefore included only patients with primary or metastatic liver cancers. Patients were enrolled to receive sequentially higher starting doses of CBL0102 in seven cohorts. Study participants were treated with CBL0102 given orally daily. Patients could continue therapy for eight weeks, or longer if they appeared to be benefiting from therapy.
News For CBLI From The Last 14 Days
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September 15, 2014
07:10 EDTCBLICleveland BioLabs announces approval to start CBLB612 Phase 1 study in Russia
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September 10, 2014
07:37 EDTCBLICleveland BioLabs announces extra 180 days to regain NASDAQ compliance
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September 8, 2014
07:06 EDTCBLICleveland BioLabs, Sabby announce resolution of litigation
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September 3, 2014
14:09 EDTCBLICleveland BioLabs up 41% in afternoon trading following FDA opinion on entolimod
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07:23 EDTCBLICleveland BioLabs to host conference call
Conference call to discuss update of July FDA meeting will be held on September 3 at 11 am. Webcast Link
07:06 EDTCBLICleveland BioLabs to submit pre-EUA application for entolimod
Cleveland BioLabs announced that the minutes from its meeting with the FDA in July confirmed that the company's existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-Emergency Use Authorization, or pre-EUA, submission for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster. The FDA has granted Fast Track status to entolimod and Orphan Drug status for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

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