Osi Pharmaceuticals, Inc.

Oncogene Science, Inc.

The United States of America As Represented by the Department of Health

Kenneth K Iwata

John D Haley

John R Stephenson

J Gordon Foulkes

Stanley C Gill

Jun Wu

Helena Yu

Gregory J Riely

Leslie I Gold

Peter Ten Dijke

George J Todaro

Peter T Dijke

Charlotte M Fryling

A novel dosing regimen for erlotinib or a pharmaceutically acceptable salt thereof is described herein. The dosing regimen demonstrates impressive control of central nervous system disease, which is better than that reported with standard dose erlotinib. The use of the novel dosing regimen for treating patients in need thereof, including for controlling formation of metastatic brain, leptomeninges, or CNS lesions in a patient with non-small cell lung cancer (NSCLC) that harbors epidermal growth factor receptor (EGFR) mutation with or without pre-existing brain metastases, is also described herein.

Pulse dosing regimen and methods of treatment

This invention is directed to a chromatographically recovered polypeptide having the N-terminal amino acid sequence Ala-Leu-Asp-Thr-Asn-Tyr-Cys-Phe-Arg-Asn-Leu-Glu-Clu-Asn-Cys-Cys-Val. This polypeptide is known as TGI, TGI-1 and TGI-2. It is also referred to as TGF-&bgr;3. The invention is also directed to a compositions which comprises the chromatographically recovered polypeptide. The invention also provides a pharmaceutical compositions to inhibit the growth of epithelial cells or heal a wound or treat a burn consisting of the chromatographically recovered polypeptide. The invention is also directed to methods which comprise administering to a subject an effective amount of the chromatographically recovered so as to thereby inhibit the growth of epithelial cells, or heal the wound or treat the burn.

Tissue-derived tumor growth inhibitor

This invention is directed to a method of treating a burn or healing a wound in a mammal by administering a chromatographically recovered polypeptide having the N-terminal amino acid sequence Ala-Leu-Asp-Thr-Asn-Tyr-Cys-Phe-Arg-Asn-Leu-Glu-Glu-Asn-Cys-Cys-Val. This polypeptide is known as TGI, TGI-1 and TGI-2. It is also referred to as TGF-&bgr;3. The invention is also directed to a compositions which comprises the chromatographically recovered polypeptide. The invention also provides a pharmaceutical compositions to inhibit the growth of epithelial cells or heal a wound or treat a burn consisting of the chromatographically recovered polypeptide.

Tissue-derived tumor growth inhibitors, methods of preparation and uses thereof

The invention provides a recombinant nucleic acid vector comprising a nucleic acid encoding a polypeptide of 112 amino acids having the amino acid sequence shown in FIG. beginning with alanine at position 1 and ending with serine at position 112. The sequence of FIG. represents a member of the TGF-&bgr; family of tumor growth factors. The invention also provides a method for producing a protein which comprises culturing the host cell under conditions suitable to express the protein in the host cell and recovering the protein so produced.

The present invention provides a method for inhibiting cytotoxic poisoning of normal cells in a subject which comprises administering to the subject an amount of a Transforming Growth Factor Beta effective to slow the growth of normal cells and thereby inhibit the cytotoxic poisoning of the normal cells in the subject. Typically, administration is topical and initiated prior to anti-neoplastic therapy such as radiation treatment or chemotherapy. The invention is particularly suited for pediatric patients.

Tissue-derived tumor growth inhibitors, methods of preparation and uses

The present invention provides (1) an antibody which (a) specifically binds to human TGF-.beta.3 and (b) exhibits substantially no cross reactivity with TGF-.beta.1 or TGF-.beta.2 and (2) antibodies directed against the pro region of the TGF-.beta. precursor. Further, this invention provides a pharmaceutical composition comprising the pro region of the TGF-.beta. precursor. Also, this invention provides methods for diagnosing, detecting and treating subjects suffering from disorders associated with TGF-.beta.3.

Method for obtaining bone marrow free of tumor cells using transforming

A substantially purified substance having the property of inhibiting tumor cell growth without inhibiting the growth of normal human cells and without having antiviral effect, further having the properties of: (a) ranging from about 3,500 to 45,000 daltons in molecular weight; (b) being heat stable at about 56.degree. C. when exposed for about 30 minutes; (c) possessing isoelectric point ranging from pI 4-8; and (d) eluting on high pressure liquid chromatography at about 10-35% of 2-propanol or about 25-50% of acetonitrile gradient, has been disclosed. The substance has utility as an antitumor or antineoplastic agent. The substance may also be useful as an index or tumorgenic activity in an organism. The mitogenic and growth stimulatory activity possessed by the substance of the present invention may be useful in wound healing and treating burn-victims.

Growing community of inventors

Westbury, NY, United States of America

Kenneth K Iwata