Accelerating Drug Development and Limiting Failure of Phase I and II Clinical Trials

[] :  Limitations in the ability to optimize dose modification within the clinical trial setting represents a serious bottleneck in the drug development process. This barrier increases development time, causes the unnecessary early termination of valuable candidates and adds up to $300 million/drug in costs. Petra Biotek are set to knock down these barriers through their computer-based Cycle Dose Modification system. The positive impact that this technology is expected to have on the clinical development process has led the FDA to make favorable comments and in a scientific presentation session meeting with the 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 the technology is now available for licensing.

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 .co.uk