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Thu Feb 22 20:51:23 2001 UTC (23 years, 2 months ago) by dpavlin
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ostatak rnd update-a

1 <p><b>NCEs in Development Phase</b></p>
2 <p><b>PLD-116</b></p>
3 <p>Approval of the German authorities was obtained to conduct the PLD-116 Phase
4 I clinical study in Germany in December 2000. Prior to that, all the activities
5 necessary to fulfill the requirements for the clinical testing of the compound
6 had been undertaken and the pre-clinical testing completed. The PLD-116 project
7 team has been established in December 1999, to develop peptide PL-10.1 into
8 a drug for the treatment of inflammatory bowel disease.</p>
9 <p><b>PLD-117</b></p>
10 <p>The peptide PLD-117 for the treatment of thrombocytopenia, a severe complication
11 of cancer chemotherapy, was brought to clinical study trials in the USA in December
12 2000. The proposed treatment is based on a unique approach using peptide that
13 activates thrombopoietin (TPO) receptor. Prior to favourable communication from
14 the FDA regarding the IND filling, and the evaluation of the clinical protocol,
15 PLIVA has signed a licensing agreement with Receptron, Inc., a Californian based
16 Biotech Company, and acquired exclusive rights to develop and market this possible
17 new drug.</p>
18 <p><b>PLD-118</b></p>
19 <p>The licensed in novel antifungal agent PLD-118 was successfully brought into
20 clinical development ahead of schedule in November 2000. PLD-118 has the potential
21 to be the first novel oral antifungal for the treatment of Candida infections
22 since the introduction of azoles in the 80's. After completing the preclinical
23 package and successful review of necessary documents by the ethics committee
24 in Germany, clinical studies started in November. According to the planned time
25 schedule, multiple dosing will be finished in May 2001, while the project team
26 will have already begun the proof of concept study, which is anticipated to
27 start in third quarter of 2001.</p>

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