| HIV (MIV-310)
Medivir pursues very extensive research into compounds against HIV
based on its knowledge of proteases and polymerases. During the year,
scientists produced a CD (candidate drug) in the NNRTI group and
embarked on clinical phase IIa trials with the compound MIV-310.
CD Selection
Medivir produced a series of new NNRTI compounds during the year from its
HIV research program. In the autumn, Medivir selected the compound
MV026048 as a CD from this series.MV026048 is highly active compared to
competing preparations, and demonstrates good efficacy against viruses
resistant to other pharmaceuticals. The compound has good pharmaceutical
qualities and oral bioavailability and is likely to be functional in
small dosages, which is a major patient benefit. Medivir is now preparing
for forthcoming clinical trials including the development of synthesis
methodologies for the compound, and the start of toxicity trials during
the year.
MIV-310
MIV-310, alovudine, active against multiresistant HIV is a patented
pharmaceutical compound in the NRTI class. When HIV RT builds strands of
DNA, one of its building blocks is thymidine. MIV-310 mimics thymidine,
but prevents further construction of the strand if embedded in it.
Normally, the virus mutates and develops resistance when it recognizes a
pharmaceutical, but MIV-310 is such a good mimic of the regular building
block, that the virus polymerase (RT) has problems distinguishing
between MIV-310 and thymidine. The polymerase therefore accepts MIV-310,
into the virus DNA, thereby disabling it.
In autumn 2001, a proof of concept phase IIa trial began. If successful,
Medivir will out license MIV-310 for onward development. The next step
is a phase IIb trial. Previous trials have demonstrated that MIV-310
elicits dosage-dependent reversible side-effects on the blood .Phase IIb
trials will be directed towards identifying the optimal dosage to
maximize virus reduction with acceptable side-effects. The market has an
acute need for NRTI pharmaceuticals as part of the combination treatment
used against HIV. Resistance development is increasing – explosively in
some Western countries – and because MIV-310 is primarily directed
towards multiresistant virus, there is a clear market.
MIV-310 is quite unlike the other market’s other offerings and may
confer Medivir with major competitive advantages. |

MIV-310 against multiresistant HIV
– activities in 2001
Compilation of IND documentation;
Summary of clinical data;
Assessment of patient risk/benefit;
Choice of trial centres and preparation
of Investigator Brochure (IB), information for the trial centres;
Ethical Committee approval to initiate
phase IIa trials (June)
Phase IIa trials began in October, and
continue
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