Claims for Patent: 6,462,017

Summary for Patent: 6,462,017

Title:	Method of reducing side effects of chemotherapy in cancer patients
Abstract:	A method for reducing the severity of chemotherapy side effects in cancer patients by administering thymosin .alpha..sub.1 in conjunction with the administration of a chemotherapy agent to the patient. As a result of the reduction of post-chemotherapy side effects, patients experience an increase in the quality of life.
Inventor(s):	Rudolph; Alfred R. (Los Altos Hills, CA), Tam; Vincent Chung-Ying (Hong Kong, HK), Quan; Maggie Jie (Shanghai, CN)
Assignee:	SciClone Pharmaceuticals, Inc. (San Mateo, CA)
Application Number:	09/561,917
Patent Claims:	1. A method of reducing side effects of chemotherapy in a cancer patient, said side effects being selected from the group consisting of loss of appetite, loss of sleep, fatigue, reduction in daily activity, decline in overall feeling, depression, nausea and vomiting and combinations of said side effects, comprising administering to a cancer patient thymosin .alpha..sub.1 (T.alpha..sub.1), said T.alpha..sub.1 being administered prior to administration to said patient of at least one chemotherapy agent selected from the group consisting of allopurinol sodium, dolasetron mesylate, pamidronate disodium, etidronate, fluconazole, epoetin alfa, levamisole HCL, amifostine, granisetron HCL, leucovorin calcium, sargramostim, dronabinol, mesna, filgrastim, pilocarpine HCL, octreotide acetate, dexrazoxane, ondansetron HCL, ondansetron, busulfan, carboplatin, cisplatin, thiotepa, melphalan HCL, melphalan, cyclophosphamide, ifosfamide, chlorambucil, mechlorethamine HCL, carmustine, lomustine, polifeprosan 20 with carmustine implant, streptozocin, doxorubicin HCL, bleomycin sulfate, daunirubicin HCL, dactinomycin, daunorucbicin citrate, idarubicin HCL, plimycin, mitomycin, pentostatin, mitoxantrone, valrubicin, cytarabine, fludarabine phosphate, floxuridine, cladribine, methotrexate, mercaptipurine, thioguanine, capecitabine, methyltestosterone, nilutamide, testolactone, bicalutamide, flutamide, anastrozole, toremifene citrate, tamoxifen, estramustine phosphate sodium, ethinyl estradiol, estradiol, esterified estrogens, conjugated estrogens, leuprolide acetate, goserelin acetate, medroxyprogesterone acetate, megestrol acetate, levamisole HCL, aldesleukin, irinotecan HCL, dacarbazine, asparaginase, etoposide phosphate, gemcitabine HCL, trastuzumab, altretamine, topotecan HCL, hydroxyurea, interferon alfa-2b, mitotane, procarbazine HCL, vinorelbine tartrate, E. coli L-asparaginase, Erwinia L-asparaginase, vincristine sulfate, denileukin diftitox, aldesleukin, rituximab, interferon alfa-2a, paclitaxel, docetaxel, BCG live (intravesical), vinblastine sulfate, etoposide, tretinoin, teniposide, porfimer sodium, fluorouracil, betamethasone sodium phosphate and betamethasone acetate, letrozole, etoposide citrororum factor, folinic acid, calcium leucouorin, 5-fluorouricil, adriamycin, cytoxan, and diamino dichloro platinum, said chemotherapy agent in combination with thymosin .alpha..sub.1 being administered in an amount effective to reduce said side effects of chemotherapy in said patient. 2. The method of claim 1 wherein said T.alpha..sub.1 also is administered subsequent to said chemotherapy agent. 3. The method of claim 1 wherein said T.alpha..sub.1 is administered on each of a plurality of days prior to said chemotherapy agent. 4. The method of claim 1 wherein a single administration of T.alpha..sub.1 is administered one day immediately prior to administration of said chemotherapy agent. 5. The method of claim 1 wherein a single administration of T.alpha..sub.1 is administered on each of two days immediately prior to administration of said chemotherapy agent. 6. The method of claim 1 wherein a single administration of T.alpha..sub.1 is administered on each of three days immediately prior to administration of said chemotherapy agent. 7. The method of claim 1 wherein a single administration of T.alpha..sub.1 is administered on each of four days immediately prior to administration of said chemotherapy agent. 8. The method of claim 1 wherein said chemotherapy agent is selected from the group consisting of etoposide citrororum factor, folinic acid, calcium leucouorin, 5-fluorouricil, adriamycin, cytoxan, diamino dichloro platinum and combinations of said chemotherapy agent. 9. The method of claim 2 wherein a single administration of T.alpha..sub.1 is administered one day immediately subsequent to administration of said chemotherapy agent. 10. The method of claim 2 wherein a single administration of T.alpha..sub.1 is administered on each of two days immediately subsequent to said administration of said chemotherapy agent. 11. The method of claim 2 wherein T.alpha..sub.1 is administered on a plurality of days prior to and subsequent to the administration of said chemotherapy agent. 12. The method of claim 2 wherein a single administration of T.alpha..sub.1 is administered one day immediately prior to and one day immediately subsequent to administration of said chemotherapy agent. 13. The method of claim 2 wherein a single administration of T.alpha..sub.1 is administered on each of two days immediately days prior to and two days immediately subsequent to the administration of said chemotherapy agent. 14. The method of claim 1 wherein T.alpha..sub.1 is administered at a dosage within a range of about 0.1-3.2 mg. 15. The method of claim 1 wherein T.alpha..sub.1 is administered at a dosage of about 1.6 mg.

Details for Patent 6,462,017

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978		2039-02-26
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2039-02-26
Amgen, Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	06/01/1989		2039-02-26