|
||
| |||||||
Dose
finding studies contribute significantly to the overall clinical development
time of new therapeutics agents. Even worse if inappropriate doses are selected,
development may be halted due to apparently excessive adverse effects or
insufficient efficacy. Dose optimization, especially on a patient-by-patient
basis, will increase drug development speed; and technology that facilitates
this could transform clinical research. Addressing this unmet need, Petra Biotek
today announce that initial testing of their revolutionary Cycle Dose
Modification (CDM)TM system has been successfully completed. This technology is
now being offered to companies wishing to accelerate the development of clinical
stage candidates. Over
the past two decades a number of "artificial intelligence" systems
have been developed in an attempt to improve the accuracy with which clinicians
can modify the dose of approved drugs administered to their patients. Early
studies demonstrated that compared to intuitive dose modification by the
physician, computer-based optimization of immunosuppressant dosage in organ
transplant recipients reduces the number of organs lost to rejection by as much
as 20%, while at the same time affording considerable pharmacoeconomic
potential by reducing hospital stay time by 50%. Advancing
early systems, Petra Biotek's CDMTM system uses modelling
technology to predict dose changes required to modify efficacy or adverse effect
marker values based on earlier dose response data. The technology employs
advanced mathmatical modelling
to fine-tune dose predictions to match the responsiveness of individual
patients. This new technology displays significant improvements over existing
tools. In
particular, for the first time CDMTM is a truly patient-centered approach whic
factors into the new dose calculation the overall clinical status of the
patient, an appreciation of the unique pharmacology of the therapeutic agents
and their relationship to surrogate markers of both efficacy and toxicity. The
CDMTM system can suggest dose adjustments for agents administered in a single or
multi-agent pharmacologic intervention by attributing the relative effect of
each agent within the therapy on multiple markers of efficacy and/or toxicity.
This allows the prescriber to precisely balance the
composition of the therapy to optimize outcome by maximizing agent exposure and
limiting adverse events. The system can also be used to modify utilization of
non-pharmacologic interventions such as life-style modification. The system
operates on a user friendly MS ExcelTM platform. Although
CDMTM is of benefit in the management of approved drugs the potential provided
by this technology would be even greater when applied to clinical development
by: decreasing the time to complete dose escalation studies; minimizing patient
drop out by limiting adverse events; improving the prediction of maximum
tolerated doses and; better identifying efficacy through improved control of
agent exposure. Alternatively
CDMTM could resurrect agents that have failed in prior trials due to an
inability to accurately determine their therapeutic window, or, this new
technology could extend and protect product life-cycle exclusivity by virtue of
its ability to optimize new formulations or combination therapies. The
possibility that CDMTM technology may positively impact the clinical development
process by dramatically reducing the cost, time frame and failure rates of
clinical trial has led the FDA to make favorable comments on this technology. In
a scientific presentation session meeting with FDA CDER (Centre for Drug
Evaluation and Research), regulatory officials expressed that they would
"Welcome the opportunity to review a submission utilizing this exciting new
technology". Following
the completion of successful proof of concept studies and in response to the
demonstrative need for such technology, CDMTM is now available for licensing.
Collaborative development partners will have first chance to evaluate the CDMTM
in formal proof of concept studies of their selected agents and develop
exclusive licensing options. Source: www.LeadDiscovery.co.uk To subscribe to DailyUpdates - click here! LeadDiscovery Reports - click here |
|
| ||||||||