News Column

Patent Issued for Targeted Delivery of Therapeutic Agents with Lyophilized Matrices

February 6, 2014



By a News Reporter-Staff News Editor at Gene Therapy Weekly -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Awad, Hani A. (Rochester, NY); Schwarz, Edward M. (Rochester, NY), filed on October 31, 2007, was published online on January 21, 2014 (see also University of Rochester).

The assignee for this patent, patent number 8632797, is University of Rochester (Rochester, NY).

Reporters obtained the following quote from the background information supplied by the inventors: "Tendon, ligament, and joint capsular injuries represent 45% of the almost 33 million musculoskeletal injuries each year in the United States, and hand injuries account for 5-10% of annual emergency department visits nationwide (Praemer et al., 1999). Common among these injuries are flexor tendon lacerations, concomitant with injury to adjacent structures, as well as ruptures, especially in individuals active in sports (Leddy, 1988). Successful repair of ruptured flexor tendons, as measured by return of gliding function, is a great challenge to hand surgeons because of the nature of tendon repair, which often results in indiscriminate adherence of the tendon to surrounding tissue (Schneider & Hunter, 1988).

"The surgeon's objective in repair is to create an environment in which the injured tendon can heal with a minimal amount of fibrosis and tissue reaction, and then following an initial protection period, to undergo controlled physical therapy regimens to mobilize the repaired tendon, and ensure restoration of the gliding function, while minimizing the risk of re-injury (Leddy, 1988; Schneider & Hunter, 1988)."

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventors' summary information for this patent: "The challenge in effecting successful soft tissue repair is largely due to the variability and unpredictability in the process of tendon repair, that almost invariably leads to significant adhesions resulting from as little insult as the passing of a suture through the tendon (Lindsay et al., 1960).

"Accordingly, there is provided in some embodiments, a surgical graft, for use in promoting healing of a diseased or injured tissue, comprising: a nonviable, substantially acellular, lyophilized, biologically derived matrix; and at least one therapeutic agent, releasably coupled to the matrix; wherein the graft is sized and shaped to be placed in a patient's body in proximity to a diseased or injured tissue; wherein, when the graft is placed in the body, the at least one therapeutic agent is released into the tissue; and wherein the at least one therapeutic agent is effective to promote healing of the tissue.

"In some embodiments, the healing comprises at least one of tissue remodeling, accelerating wound healing, achieving a reduced adhesion coefficient, and enhancing cell repopulation. In some embodiments, the healing comprises at least one of improving joint flexion, improving joint range of motion, and improving tendon gliding.

"In some embodiments, the matrix comprises a collagen. In some embodiments, the collagen is derived from at least one of tendon and ligament.

"In some embodiments, the at least one therapeutic agent is adsorbed to the matrix. In some embodiments, release of the at least one therapeutic agent is a sustained release.

"In some embodiments, the at least one therapeutic agent comprises: an expression system, configured to result in expression of at least one therapeutic protein; wherein the expression system comprises at least one of a virus, a plasmid, a bacteriophage, a chromosome, a yeast artificial chromosome, a cosmid, and a linear DNA fragment.

"In some embodiments, the therapeutic agent comprises a recombinant adeno-associated virus. In some embodiments, the expression system comprises a nucleic acid comprising at least about 80% sequence identity to (a) a nucleic acid from about position 500 to about position 2020 of SEQ ID NO: 1, or (b) the complement of the nucleotide sequence of (a).

"In some embodiments, the expression system comprises a nucleic acid encoding a protein having at least about 80% sequence identity to a protein defined by SEQ ID NO: 2.

"In some embodiments, the at least one therapeutic agent comprises a GDF5 receptor agonist. In some embodiments, the GDF5 receptor agonist comprises a protein having substantial homology to a protein as defined by SEQ ID NO: 2. In some embodiments, the GDF5 receptor agonist comprises an antibody configured to bind and activate a GDF5 receptor. In some embodiments, the at least one therapeutic agent comprises a protein having at least about 80% sequence identity to a protein as defined by SEQ ID NO: 2.

"In some embodiments there is provided a method, of promoting healing of a diseased or injured tissue, comprising: providing a graft, comprising: a nonviable, substantially acellular, lyophilized, biologically derived matrix; and at least one therapeutic agent, releasably coupled to the matrix; wherein the graft is sized and shaped to be placed in a patient's body in proximity to a diseased or injured tissue; wherein the at least one therapeutic agent is effective to promote healing of the tissue; and placing the graft in the body, such that the at least one therapeutic agent is released into the tissue.

"In some embodiments of the method, the healing comprises at least one of tissue remodeling, accelerating wound healing, achieving a reduced adhesion coefficient, and enhancing cell repopulation. In some embodiments of the method, the healing comprises at least one of improving joint flexion, improving joint range of motion, and improving tendon gliding.

"In some embodiments of the method, the matrix comprises a collagen.

"In some embodiments of the method, the at least one therapeutic agent comprises: an expression system, configured to result in expression of at least one therapeutic protein; wherein the expression system comprises at least one of a virus, a plasmid, a bacteriophage, a chromosome, a yeast artificial chromosome, a cosmid, and a linear DNA fragment. In some embodiments of the method, the therapeutic agent comprises a recombinant adeno-associated virus.

"In some embodiments of the method, the expression system comprises a nucleic acid comprising at least about 80% sequence identity to (a) a nucleic acid from about position 500 to about position 2020 of SEQ ID NO: 1, or (b) the complement of the nucleotide sequence of (a).

"In some embodiments of the method, the at least one therapeutic agent comprises a GDF5 receptor agonist.

"In some embodiments of the method, the at least one therapeutic agent comprises a protein having at least about 80% sequence identity to a protein as defined by SEQ ID NO: 2.

"In some embodiments of the method, the diseased or injured tissue comprises at least one of a rotator cuff, an Achilles tendon, a flexor tendon, an extensor tendon, a ligament, a bone, and cartilage."

For more information, see this patent: Awad, Hani A.; Schwarz, Edward M.. Targeted Delivery of Therapeutic Agents with Lyophilized Matrices. U.S. Patent Number 8632797, filed October 31, 2007, and published online on January 21, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=68&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3375&f=G&l=50&co1=AND&d=PTXT&s1=20140121.PD.&OS=ISD/20140121&RS=ISD/20140121

Keywords for this news article include: Biotechnology, Viruses, Virology, Chromosomes, Cell Nucleus, Gene Therapy, Bioengineering, Intranuclear Space, Cellular Structures, Intracellular Space, University of Rochester, Extracellular Matrix Proteins.

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Source: Gene Therapy Weekly


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