1 |
dpavlin |
1.1 |
<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> |