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Methods for drug delivery

a drug delivery and method technology, applied in the field of drug delivery, can solve the problems of drug candidates that many drug candidates fail in preclinical tests, and most of them fail to advan

Inactive Publication Date: 2014-10-30
PRESAGE BIOSCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The use of microdialysis probes as a delivery tool has several advantages, including enclosed system, efficient delivery, uniform distribution, and limited dosage. The amount of agents delivered can be accurately determined, and the probes can be customized for different target zones. The probes can also be used to induce cell death or activate cell signal pathways. The patent text suggests that microdialysis probes have promising applications in targeted tumor treatment and drug development.

Problems solved by technology

Numerous cancer-related therapeutics are under preclinical, phase I or phase II clinical trial and evaluations at any particular time; however, most of them will fail to advance.
In fact, numerous drug candidates fail in the preclinical test, and it is estimated that more than 90% of cancer-related therapeutics will fail phase I or II clinical trial evaluation.
The failure rate in phase III trials is almost 50%, and the cost of new drug development from discovery through phase III trials is between $0.8 billion and $1.7 billion and can take between eight and ten years.
In addition, many subjects fail to respond even to standard drugs that have been shown to be efficacious.
For reasons that are not currently well understood or easily evaluated, individual subjects may not respond to standard drug therapy.
One significant challenge in the field of oncology is to exclude treatment selection for individual subjects having cell autonomous resistance to a candidate drug to reduce the risk of unnecessary side effects.
A related problem is that excessive systemic concentrations are required for many oncology drug candidates in efforts to achieve a desired concentration at a tumor site, an issue compounded by poor drug penetration in many under-vascularized tumors (Tunggal et al., 1999 Clin. Canc. Res. 5:1583).

Method used

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Examples

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example 1

[0179]FIG. 7. shows an example of targeting the viable EBC-1 tumor epithelium expressing the target of interest (c-Met) using a linear array of microdialysis probes. The length of the probe / membrane can be controlled, allowing delivery of the therapeutic agents mainly to the proliferative zone of the tumor. The image is of an H&E stained slice from an EBC-1 cell line xenograft. EBC-1 cells are a lung cancer cell line with a c-Met amplification. These xenografts grow rapidly in nude mice and develop central regions of necrosis and a-cellularity as shown in white. To assess the action of a compound meant to target c-met it is necessary to direct the compound to the actively proliferating zone near the periphery of the tumor. The drawing demonstrates how microdialysis probes can be strung through the tumor and placed in only the peripheral area of the tumor, thus allowing for proper assessment of a compound(s) activity on only the tissue of interest and not regions of the tumor irrelev...

example 2

[0180]FIG. 8 shows an example of sampling multiple zones / microenvironments in solid xenograft tumors using long microdialysis membranes. Through the use of long microdialysis membranes, the entire dimension of the solid tumor and the proliferative gradient and multiple microenvironments are dosed. This represents a more complete 3-dimensional dosing than current techniques. In this image the outer circle represents the typically more proliferative zone of a tumor and the inner circle represents the often less active and more tightly packed center of a tumor. Here the drawing shows how longer microdialysis probes can be strung through the entire length of the tumor, thus allowing for delivery of compound into each of the various tissues / zones of a single tumor to evaluate differential effects of a compound or multiple compounds given variations in local tumor environment.

example 3

[0181]FIG. 9 shows a diagrammatic view of dose determination using microdialysis probes. By running a continuous loop of drug for a fixed time, the total dialysate from tubing can be collected and analyzed using HPLC, fluorescence / absorbance, etc. to determine the amount of therapeutic agents delivered through passive diffusion. In this drawing the tumor is represented by the two shaded circles, one inside the other. The microdialysis probe is shown as the column strung from one side of the tumor to the other with a closed loop of tubing connected to the microdialysis probe and passing through a peristaltic pump represented by the wheel at the bottom. This set up allows for a known concentration of compound to be introduced into the closed system. In this system one can deliver compound either passively or actively to the tumor as well as collect signaling molecules from the tumor into the closed loop system. Thus after a given amount of time the fluid in the closed system can be co...

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Abstract

Methods and devices for delivering an agent to a solid tissue in vivo for assessment of efficacy are described. One method involves withdrawing of a needle from and injecting of the agent into the solid tissue; another method involves delivering the agent using a plurality of microdialysis probes to a solid tissue.

Description

CROSS-REFERENCE[0001]This application claims the benefit of priority under 35 U.S.C. section 119(e) to U.S. Provisional Application 61 / 553,003, filed Oct. 28, 2011; and U.S. Provisional Application 61 / 680,847, filed Aug. 8, 2012; the contents of which are incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]Numerous cancer-related therapeutics are under preclinical, phase I or phase II clinical trial and evaluations at any particular time; however, most of them will fail to advance. In fact, numerous drug candidates fail in the preclinical test, and it is estimated that more than 90% of cancer-related therapeutics will fail phase I or II clinical trial evaluation. The failure rate in phase III trials is almost 50%, and the cost of new drug development from discovery through phase III trials is between $0.8 billion and $1.7 billion and can take between eight and ten years.[0003]In addition, many subjects fail to respond even to standard drugs that have been sh...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M5/00A61B10/02A61B10/00
CPCA61M5/00A61B10/02A61B10/00A61M37/0015A61K31/4745A61M5/1452A61K49/0017A61M5/427G01N33/5011
Inventor FRAZIER, JASONHOFFER, RICHARDGRENLEY, MARC
Owner PRESAGE BIOSCI
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