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<p><b>NCEs in Development Phase</b></p> |
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<p><b>PLD-116</b></p> |
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<p>Approval of the German authorities was obtained to conduct the PLD-116 Phase |
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I clinical study in Germany in December 2000. Prior to that, all the activities |
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necessary to fulfill the requirements for the clinical testing of the compound |
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had been undertaken and the pre-clinical testing completed. The PLD-116 project |
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team has been established in December 1999, to develop peptide PL-10.1 into |
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a drug for the treatment of inflammatory bowel disease.</p> |
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<p><b>PLD-117</b></p> |
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<p>The peptide PLD-117 for the treatment of thrombocytopenia, a severe complication |
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of cancer chemotherapy, was brought to clinical study trials in the USA in December |
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2000. The proposed treatment is based on a unique approach using peptide that |
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activates thrombopoietin (TPO) receptor. Prior to favourable communication from |
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the FDA regarding the IND filling, and the evaluation of the clinical protocol, |
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PLIVA has signed a licensing agreement with Receptron, Inc., a Californian based |
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Biotech Company, and acquired exclusive rights to develop and market this possible |
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new drug.</p> |
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<p><b>PLD-118</b></p> |
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<p>The licensed in novel antifungal agent PLD-118 was successfully brought into |
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clinical development ahead of schedule in November 2000. PLD-118 has the potential |
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to be the first novel oral antifungal for the treatment of Candida infections |
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since the introduction of azoles in the 80's. After completing the preclinical |
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package and successful review of necessary documents by the ethics committee |
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in Germany, clinical studies started in November. According to the planned time |
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schedule, multiple dosing will be finished in May 2001, while the project team |
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will have already begun the proof of concept study, which is anticipated to |
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start in third quarter of 2001.</p> |