Therapeutic regimen for treating cancer

a cancer and therapy regimen technology, applied in the field of cancer therapy regimens, can solve the problems of limited success of clinicians, inability to effectively treat cancer, and inability to meet the needs of patients,

Inactive Publication Date: 2007-07-19
GENVEC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Yet, despite extensive research into the disease, effective cancer therapeutics remain elusive for the medical community.
Clinicians have realized limited success with the current standard therapies: chemotherapy, radiation therapy, and surgery.
However, each therapy has inherent limitations.
Chemotherapy and radiation therapy cause extensive damage to normal, healthy tissue, despite efforts to target such therapy to abnormal tissue (e.g., tumors).
Surgery can be effective in removing masses of cancerous cells; however, even the most talented surgeon cannot ensure complete removal of affected tissue nor are all tumors in an anatomical location amenable to surgical removal.
However, the use of TNF in humans as an anti-cancer agent has been limited by its severe systemic effects, including hypotension and respiratory insufficiency (Mauceri et al., supra).

Method used

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  • Therapeutic regimen for treating cancer
  • Therapeutic regimen for treating cancer
  • Therapeutic regimen for treating cancer

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0092] This example demonstrates the safety and efficacy of the pharmaceutical composition of the present invention comprising (i) a pharmaceutically acceptable carrier and (ii) an adenoviral vector comprising a nucleic acid sequence encoding TNF-α operably linked to a radiation-inducible promoter, wherein the dose comprises from about 4×109 to about 4×1011 particle units (pu) of adenoviral vector, in a clinically-relevant animal model.

[0093] Preclinical toxicology studies were performed in nude mice (nu / nu) bearing a human SQ-20B squamous cell carcinoma zenograft (n=80) and Balb / c mice (n=100). Ten nu / nu mice / sex / group in four groups totaling 80 mice were used in the study. The four groups consisted of: 1) vehicle control, 2) vehicle control plus radiation, 3) pharmaceutical composition comprising 4×109 pu of adenoviral vector plus radiation, and 4) pharmaceutical composition comprising 4×1010 pu of adenoviral vector plus radiation. Doses of vehicle or pharmaceutical composition c...

example 2

[0098] This example illustrates use of the inventive method to therapeutically treat cancer in a human as indicated by size reduction of tumor mass.

[0099] Patients with solid tumors accessible for repeated intratumoral injections were selected for treatment using the inventive method. These patients had failed one or more prior therapies. Patients were injected intra-tumorally with a pharmaceutical composition comprising one of five dose levels of the TNF-α coding sequence-containing adenoviral vector described in Example 1 (4×109-4×1011 pu in ½ log increments) over a maximum 6-week therapeutic period. Several patients comprised a lesion treated by radiation only, which served as a control. A single dose of pharmaceutical composition was administered via multiple injections to the tumor on day 1 and day 4 of weeks 1 and 2 of the therapeutic period, and once weekly for weeks 3-6. For each dose, the multiple injections were administered in a pattern such that the injections were equa...

example 3

[0103] This example illustrates use of the inventive method to reduce the size of a tumor associated with soft tissue sarcoma.

[0104] Patients with extremity soft tissue sarcomas are selected for treatment using the present inventive method. Patients are injected intratumorally with a pharmaceutical composition comprising one of five dose levels of the TNF-α coding sequence-containing adenoviral vector described in Example 1 (4×109-4×1012 pu in 1-½ log increments) over a 5-week therapeutic period. A single dose of pharmaceutical composition is administered via multiple injections to the tumor on day 1 and day 4 of week 1 of the therapeutic period, and once weekly for weeks 2-5. For each dose, the multiple injections are administered to the tumor in parallel lines. Concomitant radiation therapy is initiated in week 1 and administered for five consecutive days, and not administered for two days, for each week of the therapeutic period, achieving a total dose of 30-70 Gy.

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Abstract

The invention provides a method for treating cancer in a human comprising administering to the human a dose of a pharmaceutical composition comprising (i) a pharmaceutically acceptable carrier and (ii) an adenoviral vector comprising a nucleic acid sequence encoding TNF-α operably linked to a promoter, wherein the dose comprises about 1×107 to about 4×1012 particle units (pu) of replication-deficient adenoviral vector, at least once in a therapeutic period comprising up to 10 weeks, whereby the cancer in human is treated. The invention further provides a method of treating a human for multiple tumors, wherein the method comprises contacting a first tumor with a dose of the pharmaceutical composition at least once in a therapeutic period comprising up to about 10 weeks, whereby the human is treated for the first tumor and one or more additional tumors.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This patent application is a continuation of copending U.S. patent application Ser. No. 10 / 151,633, filed May 17, 2002, which is a continuation-in-part of copending U.S. patent application Ser. No. 10 / 001,017, filed Nov. 2, 2001.FIELD OF THE INVENTION [0002] This invention pertains to a method and a composition for treating cancer in a human. BACKGROUND OF THE INVENTION [0003] The desire of cancer research is the identification of a therapy effective on one or several different types of cancers. The American Cancer Society, alone, distributed approximately $1 billion last year to cancer researchers working to elucidate the mechanisms of a multitude of cancer types. Yet, despite extensive research into the disease, effective cancer therapeutics remain elusive for the medical community. Clinicians have realized limited success with the current standard therapies: chemotherapy, radiation therapy, and surgery. However, each therapy has inher...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K48/00C12N15/861A61N5/10A01N63/00A61KA61K35/76A61K35/761A61K38/00A61P35/00C12N7/00
CPCA61K38/191A61K35/761C12N2710/10332C12N2710/10341A61P35/00A61K2300/00
Inventor RASMUSSEN, HENRIK S.CHU, KAREN W.
Owner GENVEC INC
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