AU632528B2 - Use of certain gamma interferons in the preparation of pharmaceutical compositions intended for the treatment of cancer of the ovary by intra-peritoneal route - Google Patents
Use of certain gamma interferons in the preparation of pharmaceutical compositions intended for the treatment of cancer of the ovary by intra-peritoneal route Download PDFInfo
- Publication number
- AU632528B2 AU632528B2 AU48953/90A AU4895390A AU632528B2 AU 632528 B2 AU632528 B2 AU 632528B2 AU 48953/90 A AU48953/90 A AU 48953/90A AU 4895390 A AU4895390 A AU 4895390A AU 632528 B2 AU632528 B2 AU 632528B2
- Authority
- AU
- Australia
- Prior art keywords
- polypeptide
- cancer
- treatment
- ovary
- gamma interferon
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
- 206010061535 Ovarian neoplasm Diseases 0.000 title claims abstract description 13
- 206010033128 Ovarian cancer Diseases 0.000 title claims abstract description 12
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 6
- 238000007912 intraperitoneal administration Methods 0.000 title description 9
- 238000002360 preparation method Methods 0.000 title description 6
- 102000014150 Interferons Human genes 0.000 title description 5
- 108010050904 Interferons Proteins 0.000 title description 5
- 229940047124 interferons Drugs 0.000 title description 5
- 102000008070 Interferon-gamma Human genes 0.000 claims abstract description 24
- 108010074328 Interferon-gamma Proteins 0.000 claims abstract description 24
- 229940044627 gamma-interferon Drugs 0.000 claims abstract description 24
- 229920001184 polypeptide Polymers 0.000 claims abstract description 14
- 102000004196 processed proteins & peptides Human genes 0.000 claims abstract description 14
- 108090000765 processed proteins & peptides Proteins 0.000 claims abstract description 14
- 230000010412 perfusion Effects 0.000 claims abstract description 8
- 230000000694 effects Effects 0.000 claims abstract description 7
- 238000000034 method Methods 0.000 claims description 11
- 238000002347 injection Methods 0.000 claims description 9
- 239000007924 injection Substances 0.000 claims description 9
- 206010028980 Neoplasm Diseases 0.000 description 5
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 201000011510 cancer Diseases 0.000 description 3
- 230000003902 lesion Effects 0.000 description 3
- 208000007660 Residual Neoplasm Diseases 0.000 description 2
- 230000000840 anti-viral effect Effects 0.000 description 2
- 238000001574 biopsy Methods 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 238000010562 histological examination Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000011780 sodium chloride Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 108700028369 Alleles Proteins 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 108020004511 Recombinant DNA Proteins 0.000 description 1
- 241000711975 Vesicular stomatitis virus Species 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000001093 anti-cancer Effects 0.000 description 1
- 230000001028 anti-proliverative effect Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000010367 cloning Methods 0.000 description 1
- 230000009089 cytolysis Effects 0.000 description 1
- 239000000385 dialysis solution Substances 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 210000005260 human cell Anatomy 0.000 description 1
- 230000002519 immonomodulatory effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000002350 laparotomy Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 229930182817 methionine Natural products 0.000 description 1
- 125000001360 methionine group Chemical group N[C@@H](CCSC)C(=O)* 0.000 description 1
- 210000001539 phagocyte Anatomy 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 210000004881 tumor cell Anatomy 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/217—IFN-gamma
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Use of a recombinant polypeptide having an activity of the human gamma-interferon type for preparing a pharmaceutical composition which can be administered intraperitoneally in perfusion and is intended for the effective treatment of ovarian cancer.
Description
Fr
AUSTRALIA
PATENTS ACT 1952 Form COMPLETE SPECIFIC.ATION
(ORIGINAL)
63 252- FOR OFFICE USE Short Title: Int. Cl: Application Nunmber: Lodged: C' CSiplete Specificatlon LDAged: 0 Accepted: 0 Lapsed: Published: Ydrpl)y Related Art: 1 0 0 a NGrne of Applicant: Address ofl; Applicant: Actual irtventoro: Address fDY Service: TO BE COMPLETED BY APPLICANT
ROUSSEL-UCLAF
35, Boulevard des Inwdildes, 75007, Paris, France IMAUD BRANDELY and DANIELLE LANDO CALLINAN LAWRIE, Patent Attorneys, 278 High Street, K~ew, Victoria 3101, Australia.
Complete Specification for the Invent Oon 3ntitled: USE OF CERTAIN GAMMA INTERFERONS IN THlE PREPARATION OF PHARMACEUTICAL C01MW)-SITIONS INTENDED FOR THE TREATMENT OF CANCER OF THE OVARY BY INTIXA-PEiUTONEAL ROUTE The following statement is a full description of this invention, including the best method of performing It known to me,-- 4 -5 rror~un la USE OF CERTAIN GAMMA INTERFERDNS IN THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS INTENDED TO THE TREATMENT OF CANCER OF THE OVARY BY INTRA-PERITONEAL ROUTE Use of certain gamma interferons in the preparation of pharmaceutical compositions intended for the treatment of cancer of the ovary by intra-peritoneal route.
Gamma interferon, in addition to its anti-viral and anti-proliferative properties, possesses a powerful immunomodulatory activity which distinguishes it from the alpha and beta interferons. It stimulates the phagocytic cells, enabling in particular the lysis of certain tumour cells. The study of the tolerance of gamma interferon in patients at the terminal stage of cancer has not led to observations of remissions from these cancers (Vadhan-Raj, S et al. (1986) J. Clin.
S Oncol. 4 137-146 or Van Der Burg, M et al. (1985) J. Biol. Resp. Mod. 4 (264o, 15 272)).
o a The effectiveness of gamma interferon on various fresh, human cancer cells, according to the so-called "human tumor cloning system" test described by S Hamburger et al., was shown in Patent Application WO 87/05518, notably on ovarian cancer colonies. Following these observations, clinical studies were carried out, in particular with patients having cancer of the ovary. However, the effectiveness of the gamma interferon in viv, was not observed either for administration by intravenous route (Welander, C.E. et al. Am. J. Clin. Oncol.
(1988) 11 465-4b9), or according to a protocol using administration by intraperitoneal route [(D'Acquisto, R et al. J. Clin. Oncol. (1988) 6 (689-695)]. In a let I I lb general way, it is recognized that the anti-cancerous action of gamma interferon necessitates its use in combination with other therapeutic agents [(Saito, T et al., Cancer Chemother. Pharmacol. (1989) 19 (233-239)]. Now the Applicant has just obtained results showing that, in certain conditions of use, certain gamma interferons show an activity on cancer of the ovary.
Therefore the invention relates to a method for treating cancer of the ovary in a patient requiring such treatment which method comprises intraperitoneally administering to said patient by perfusion a recombinant polypeptide of human gamma interferon type with a specific activity at least equal to 1 x 10 7 U/mg, o <~-~rzt~rrzt7v'zv 2 -efeeft-i-ve-tr-ea tment-o- ovar-ian- cancer-eharaeter-i-d -poIlypeptide used is a product having a-specf±cacts±-at s equalt--to- These results are contrary to the absence of effectiveness reported by D'Acquisto, R, for a recombinant gamma interferon administered through perfusion by intra-peritoneal route in the treatment of refractory ovarian cancers. The invention describes the use of human gamma interferon in a treatment, the effectivene.ss of which is shown by a response rate of 58%, for an administration by intra-peritoneal route through perfusion, in patients with ovarian cancer having residual tumour lesions after exeresis surgery and chemotherapy. The specific activity of the recombinant products used 7 in the invention is at least equal to 1.10 U/mg, determined according to ',he standard test by measurement of the anti-viral activity relative to an NIH scale on Wish human cells infected by the vesicular stomatitis virus, and enables the administration of effective doses which are lower than the tolerated maximum dose expressed in mg of product. The use according to the invention therefore makes use of recombinant pilypeptides having an activity of gamma interferon type and possessing a high degree of puri.ty. The pharmaceutical compositions prepared according to the invention preferably contain a recombinant human gamma interferon, that is, obtained by the technology of recombinant DNA, for example as described by Gray et al.
in Nature (1982) 295 503-500 or in Patent Application EP 77670, alleles or derivatives of these products as described for example in Patent Application EP 161504. Purification techniques known to an expert are then used, which enable the preparation of iigh-purity products. The gamma interferon is notably that obtained starting with a strain of E. coli and containing 143 amino acids corresponding to the sequence of natural gamma interferon with a supplementary Nterminal methionine.
In particular a subject of the invention is the use, characterized in that the polypeptide employed, preferably gamma interferon, is administered at a dose of 10 to 50.10 U/M per injection and more particularly the use characterized in that the polypeptide employed, preferably gamma interferon, is administered at a dose of 20.10 U/M2 per injection.
I 7 ~iPI 3 Notably a subject of the invention is the use, characterized in that the polypeptide employed, preferably gamma interferon, is administered repeatedly for at least two non-consecutive days per week and quite especially the use characterized in that the polypeptide employed, preferably gamma interferon, is administered repeatedly for at least two months, for example for three months.
The dose administered, the frequency of the inject-on and the ouration of the triatment vary as a function of the condition of the patient.
The polypeptide employed, preferably gamma interferon, is contained in a pharmaceutical composition, preferably lyophilized in dropping bottles containing from 0.2 to 1 mg of active principle and which is re-constituted with distilled water for injection. The solution obtained is immediately diluted with a solute which contributes to the stability of the active principle during perfusion, for example sodium chloride at 0.9%.
By way of example, a preparation was made for intra-peritoneal perfusion of formula: gamma interferon 1 mg excipient 50 mg sterilized wat"r 4.1 ml sodium chloride at 0.9% 250 ,l According to the preferred use of the invention, the polypeptide used, preferably gamma interferon, has a specific activity of 7 6 2 2.10 U/mg, the dose is 20.10 U/M the frequency of the injection is twice weekly and the duration of the administration is 4 months, representing in total about 720.106 U/M 2 and 36 mg/M 2 of gamma interferon administered to the patient by intra-peritoneal route.
The following results illustrate the invention without however limiting it: The study includes patients having residual tumour lesions the size of which varies from microscopic to more than 20 mm after treatment by chemotherapy and exeresis surgery, the effectiveness of which was evaluated at 20% of complete response after a histological examination carried out during a second operation.
The gamma interferon compositions prepared according to the I IILP-L- ~II HF.-~ hC"" 4 invention allow the injection of doses of 20.10 U/M that is 1 mg/M per injection, at a rate of 2 injections per week for 2 to 4 months, by intra-peritoneal route according to an ambulatory method. The compositions described above are used, containing 1 mg of active principle which is perfused in the patient for a time not exceeding 2 hours, after previous perfusion of dialysis fluid varying, according to the condition of the patient, from 1 to 2 litres and constituted bI Dianeal 137 with 1.36% of glucose from TRAVENOL.
The evaluation of the patients' responses is effected during a laparotomy by macroscopic and histological examinations with biopsies of the previously affected sites and biopsie.: at random.
For 12 re-evaluated patients, the following responses were obtained: Patient 201 301 503 801 803 1001 1002 1004 1101 1102 1901 1902
S
P
CR
PR
Size of lesions 1 20 micro micro 5 20 20 20 5 micro micro micro micro stabilization progression complete response partial response Duration of treatment (months) 4 months 3 months 4 months 4 months 3 months 4 months 3 months 2.5 months 4 months 4 months 4 months 4 months Response
S
P
CR
P
PR
S
CR
CR
CR
P
PR
PR
The results show 4 complete responses and 3 partial responses, that is a response tate of 58%.
Claims (4)
1. A method for treating cancer of the ovary in a patient requiring such treatment which method comprises intraperitoneally administering to said patient by perfusion a recombinant polypeptide of human gamma interferon type with a specific activity at least equal to 1 x 107 U/mg.
2. The method of claim 1, wherein said polypeptide is gamma interferon.
3. The method of claim 1 or claim 2, wherein said polypeptide is administered at a dose of 10 to 50 x 106 U/M 2 per injection.
4. The method of claim 1 or claim 2, wherein said polypeptide is administered Sat a dose of 20 x 10 6 U/M 2 per injection. The method of any one of claims 1 to 4, wherein said polypeptide is administered twice a week on non-consecutive days per week. 6, The method of any one of claims 1 to 5, wherein said polypeptide is 0 administered repeatedly for at least two months. DATED this 14th day of October 1992. ROUSSEL-UCLAF By their Patent Attorneys: CALLINAN LAWRIE q'1ltiAO. b W^>SjS~jw
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR8901346A FR2644067B1 (en) | 1989-02-02 | 1989-02-02 | USE OF CERTAIN GAMMA INTERFERONS FOR THE PREPARATION OF PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF OVARY CANCER BY THE INTRAPERITONEAL ROUTE |
| FR8901346 | 1989-02-02 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU4895390A AU4895390A (en) | 1990-08-09 |
| AU632528B2 true AU632528B2 (en) | 1993-01-07 |
Family
ID=9378406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU48953/90A Expired AU632528B2 (en) | 1989-02-02 | 1990-02-01 | Use of certain gamma interferons in the preparation of pharmaceutical compositions intended for the treatment of cancer of the ovary by intra-peritoneal route |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP0381584B1 (en) |
| JP (1) | JPH0772137B2 (en) |
| KR (1) | KR100203316B1 (en) |
| AT (1) | ATE99954T1 (en) |
| AU (1) | AU632528B2 (en) |
| CA (1) | CA2009106A1 (en) |
| DE (1) | DE69005837T2 (en) |
| DK (1) | DK0381584T3 (en) |
| FR (1) | FR2644067B1 (en) |
| HU (1) | HU204711B (en) |
| OA (1) | OA09191A (en) |
| ZA (1) | ZA90671B (en) |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL76591A0 (en) * | 1984-10-05 | 1986-02-28 | Bioferon Biochem Substanz | Pharmaceutical compositions containing ifn-ypsilon and processes for the preparation thereof |
| EP0302862A1 (en) * | 1986-03-17 | 1989-02-15 | Schering Corporation | Treatment of cancers with gamma interferon |
-
1989
- 1989-02-02 FR FR8901346A patent/FR2644067B1/en not_active Expired - Fee Related
-
1990
- 1990-01-19 HU HU90202A patent/HU204711B/en not_active IP Right Cessation
- 1990-01-24 JP JP2012778A patent/JPH0772137B2/en not_active Expired - Lifetime
- 1990-01-30 ZA ZA90671A patent/ZA90671B/en unknown
- 1990-02-01 AT AT90400266T patent/ATE99954T1/en not_active IP Right Cessation
- 1990-02-01 DE DE90400266T patent/DE69005837T2/en not_active Expired - Lifetime
- 1990-02-01 DK DK90400266.4T patent/DK0381584T3/en active
- 1990-02-01 AU AU48953/90A patent/AU632528B2/en not_active Expired
- 1990-02-01 EP EP90400266A patent/EP0381584B1/en not_active Expired - Lifetime
- 1990-02-01 CA CA002009106A patent/CA2009106A1/en not_active Abandoned
- 1990-02-01 KR KR1019900001167A patent/KR100203316B1/en not_active Expired - Lifetime
- 1990-02-02 OA OA59732A patent/OA09191A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0772137B2 (en) | 1995-08-02 |
| EP0381584A2 (en) | 1990-08-08 |
| FR2644067B1 (en) | 1993-02-05 |
| ZA90671B (en) | 1991-04-24 |
| HUT54302A (en) | 1991-02-28 |
| CA2009106A1 (en) | 1990-08-02 |
| KR100203316B1 (en) | 1999-06-15 |
| JPH02235818A (en) | 1990-09-18 |
| HU204711B (en) | 1992-02-28 |
| EP0381584B1 (en) | 1994-01-12 |
| DE69005837D1 (en) | 1994-02-24 |
| OA09191A (en) | 1992-06-30 |
| ATE99954T1 (en) | 1994-01-15 |
| EP0381584A3 (en) | 1991-11-06 |
| KR900012628A (en) | 1990-09-01 |
| DK0381584T3 (en) | 1994-02-14 |
| HU900202D0 (en) | 1990-03-28 |
| DE69005837T2 (en) | 1994-05-11 |
| FR2644067A1 (en) | 1990-09-14 |
| AU4895390A (en) | 1990-08-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PC | Assignment registered |
Owner name: AVENTIS PHARMA S.A. Free format text: FORMER OWNER WAS: HOECHST MARION ROUSSEL |