KR20020080383A - 바이러스 주 - Google Patents
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- KR20020080383A KR20020080383A KR1020027009410A KR20027009410A KR20020080383A KR 20020080383 A KR20020080383 A KR 20020080383A KR 1020027009410 A KR1020027009410 A KR 1020027009410A KR 20027009410 A KR20027009410 A KR 20027009410A KR 20020080383 A KR20020080383 A KR 20020080383A
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Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
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- A—HUMAN NECESSITIES
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Abstract
Description
세포주 | 감염 후 경과시간 | JS=1MOI=0.1 MOI=1 | 17MOI=0.1 MOI=1 | BL1MOI=0.1 MOI=1 | |||
비감염된 대조 웰에 대한 살아있는 세포 수의 퍼센트 | |||||||
SK-MEL-28 | 24시간복제 시료 | 4133.7 | 87 | 57.362.6 | 1919.3 | 43.739 | 6.676.33 |
48시간 | 5.515.05 | 1.90.8 | 7.47.1 | 3.72.6 | 4.54.8 | 0.81.1 | |
72시간 | 00 | 00 | 00 | 00 | 00 | 00 | |
MDA-MB-231 | 24시간 | 44.9144.02 | 16.716.96 | 69.3765.8 | 36.3434.55 | 55.6360.45 | 26.7925.27 |
48시간 | 14.113.5 | 4.73.8 | 27.927 | 8.38.5 | 1820 | 6.78.3 | |
72시간 | 00 | 00 | 2.912.91 | 0.731.27 | 1.461.64 | 00 | |
HT-29 | 24시간 | 37.5339.24 | 1515 | 47.2845.76 | 23.6124.24 | 42.2243.04 | 22.1521.33 |
48시간 | 13.214 | 2.33 | 29.427.7 | 4.24.7 | 18.421.2 | 4.43.7 | |
72시간 | 00 | 00 | 1.571.89 | 00 | 1.641.57 | 00 |
Claims (61)
- 변이된 종양분해 비실험실 바이러스 주(modified, oncolytic, non-laboratory virus strain)의 암의 종양분해 치료(oncolytic treatment)를 위한 약물의 제조를 위한 용도.
- 제 1항에 있어서,(a) 숙주로부터 비변이된 전구 균주(unmodified precursor strain)의 분리 이후에 일년 또는 그 이하의 배양을 거치거나,(b) 숙주로부터 비변이된 전구 균주의 분리 이후에 100회 또는 그 이하의 연속된 계대를 거치거나,(c) 종양세포를 감염시키거나 종양세포에서 복제하거나, 종양세포를 죽이거나 조직내 세포간에 전파되는, 등가의 변이를 갖는 참조 실험실 주(reference laboratory strain)보다 더 강력한 능력을 갖거나, 또는(d) (c)에서 정의된 성질의 하나 또는 그 이상의 측면에서 비변이된 전구 균주의 실질적인 능력을 갖는 비실험실 주를 포함하는,암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 2항에 있어서,(c)에서의 전기 더 강력한 능력은 통계적으로 현저히 강력한 능력을 나타내거나, 또는 (d)에서의 전기 실질적인 능력은 통계적으로 동일한 능력 또는 현저히 다르지 아니한 능력을 나타내는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 1항 내지 제 3항의 어느 하나의 항에 있어서,전기 비실험실 주는 허피스 바이러스(herpes virus), 아데노바이러스(adenovirus), 피코나바이러스(picornavirus), 레트로바이러스(retrovirus) 또는 알파바이러스(alphavirus) 균주 중의 어느 한 균주임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 4항에 있어서,전기 비실험실 주는 허피스 바이러스 주임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 5항에 있어서,전기 비실험실 주는 허피스 단순포진 바이러스(herpes simplex virus, HSV) 주임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 6항에 있어서,HSV 균주는 HSV1 또는 HSV2 균주임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 5항 내지 제 7항의 어느 하나의 항에 있어서,HSV 균주에서 기능성 ICP34.5-코딩 유전자, 기능성 ICP6-코딩 유전자, 기능성 당단백질 H-코딩 유전자, 기능성 티미딘 키나제(thymidine kinase)-코딩 유전자 중의 하나 또는 그 이상이 결핍되거나; 또는, 비HSV 균주에서 전기 HSV 유전자 중 하나와 등가물인 기능성 유전자가 결핍되도록, 변이되는 것을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 5항 내지 제 8항의 어느 하나의 항에 있어서,균주는 HSV 균주이고, 바이러스는 기능성 ICP34.5-코딩 유전자가 결핍됨을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 9항에 있어서,바이러스는 기능성 ICP47 유전자가 추가적으로 결핍됨을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 1항 내지 제 10항의 어느 하나의 항에 있어서,전기 비실험실 주는 외래유전자(heterologous gene)를 추가적으로 포함하는 것을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 11항에 있어서,전기 외래유전자는 면역반응을 변형시킬 수 있는 유전자임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 12항에 있어서,전기 면역반응을 변형시킬 수 있는 외래유전자는, 면역촉진 폴리펩티드 또는 면역반응을 변형시킬 수 있는 다른 유전자 산물, 프로드러그 활성화제(prodrug activator), 종양억제제(tumour suppressor) 또는 프로-주하수증 유전자 산물(pro-apoptotic gene product)을 암호화하는 것을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 13항에 있어서,전기 면역촉진 폴리펩티드는 과립구 마크로파지 콜로니-생성촉진인자 (granulocyte macrophage colony-stimulating factor, GM-CSF), 다른 시토카인(cytokine) 또는 케모카인(chemokine), RANTES, B7.1 또는 B7.2 또는 IL12이거나, 프로드러그 활성화제는 니트로 환원효소(nitroreductase) 또는 시토크롬(cytochrome) P450이거나, 종양억제제는 p53인 것을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 제 2항 내지 제 14항의 어느 하나의 항에 있어서,비실험실 주는 HSV 균주이고, 제 2항에서 정의된 참조균주는 비실험실 주에 등가의 변이를 갖는 HSV1 균주 17+, HSV 균주 F 또는 HSV1 균주 KOS임을 특징으로 하는암의 종양분해 치료를 위한 약물의 제조를 위한 용도.
- 외래유전자를 포함하는 변이된 복제능력이 없는(replication incompetent) 비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 16항에 있어서,(a) 숙주로부터 비변이된 전구 균주의 분리 이후에 일년 또는 그 이하의 배양을 거치거나,(b) 숙주로부터 비변이된 전구 균주의 분리 이후에 100회 또는 그 이하의 연속된 계대를 거치거나,(c) 목적세포의 감염에 있어서, 등가의 변이를 갖는 참조 실험실 주 보다 더 강력한 능력을 갖거나,(d) 신경세포(neuron)를 감염시키거나 신경조직내의 세포간에 전파되거나 수상(dendritic cell)를 감염시키거나 또는 면역반응을 유도하는, 등가의 변이를 갖는 참조 실험실 주 보다 더 강력한 능력을 갖거나, 또는(e) (c) 또는 (d)에서 정의된 성질의 하나 또는 그 이상의 측면에서 비변이된 전구 균주와 실질적으로 동일한 능력을 갖는,비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 17항에 있어서,(c)에서의 전기 더 강력한 능력은 통계적으로 현저히 강력한 능력을 나타내거나, 또는 (d)에서의 전기 실질적인 능력은 통계적으로 동일한 능력 또는 현저히 다르지 아니한 능력을 나타내는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 18항에 있어서,비실험실 주는 제 4항 내지 제 7항의 어느 하나의 항에서 정의된 균주에 해당하는 것을 특징으로 하는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 19항에 있어서,HSV 균주에서 기능성 ICP27-코딩 유전자, 기능성 ICP4-코딩 유전자, 기능성 ICP0-코딩 유전자 또는 ICP22-코딩 유전자의 하나, 둘, 셋 또는 모든 것이 결핍되거나; 또는, 비HSV 균주에서 전기 HSV 유전자 중 하나와 등가물인 기능성 유전자가 결핍되거나; 및/또는, HSV 균주에서 기능성 vmw65 유전자의 돌연변이로 인한 결핍에 의하여, 전사촉진 활성이 중단되거나; 또는, 비HSV 균주에서 기능성 vmw65 유전자의 돌연변이로 인한 결핍에 의하여, 전사촉진 활성이 중단되도록 변이되는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 16항 내지 제 20항의 어느 하나의 항에 있어서,약물은 약물을 말초신경에 투여함에 의하여 말초신경계 질병을 치료하거나 예방하기 위한 용도이고, 전기 외래유전자는 전기 말초신경계 질병의 치료에 있어서 치료용도의 폴리펩티드 또는 안티센스 RNA(antisense RNA)를 코딩하는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- (ⅰ) 외래유전자를 포함하는 제 16항 내지 제 21항의 어느 하나의 항에서 정의된 복제능력이 없는 허피스 바이러스를 말초신경에 접종하는 단계; 및,(ⅱ) 질병에 관련된 전기 유전자의 효과를 측정하기 위하여, 질병의 표현형 또는 전기 세포의 유전자 발현효과를 모니터링하는 단계를 포함하는, 유전자가 말초신경계 질병과 연관된 표현형 또는 말초신경계 질병과 관련된 말초신경계 세포에 효과가 있는지를 측정하는 방법.
- 제 16항 내지 제 20항의 어느 하나의 항에 있어서,약물은 중추신경계 질병을 치료하거나 예방하기 위한 용도이고, 외래유전자는 전기 질병을 치료하는데 있어서, 치료용도의 폴리펩티드 또는 안티센스 RNA를 암호화하며, 복제능력이 없는 허피스 바이러스는(a) 적어도 2개의 급발성초기 유전자(immediate early gene)의 발현을 억제하거나 감소시키는 하나 또는 그 이상의 돌연변이; 및,(b) 허피스 바이러스의 잠복기 동안에 활발하게 작동하는 프로모터에 작동가능하게 연결된 외래유전자(heterologous gene)를 포함하는,비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 27항에 있어서,전기 균주는 HSV 균주이고, 전기 급발성초기 유전자는 ICP0, ICP4, ICP22 및 ICP27을 암호화하는 유전자의 하나, 둘, 셋 또는 모든 것임을 특징으로 하는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- (ⅰ) 제 23항 또는 제 24항에서 정의된 복제능력이 없는 허피스 바이러스를 중추신경계의 세포에 접종하는 단계; 및,(ⅱ) 유전자가 전기 세포 또는 표현형에 효과가 있는지를 측정하기 위하여, 질병의 표현형 또는 전기 세포의 유전자 발현효과를 모니터링하는 단계를 포함하는, 유전자가 중추신경계 질병과 연관된 표현형 또는 중추신경계 질병과 관련된 중추신경계 세포에 효과가 있는지를 측정하는 방법.
- 제 16항 내지 제 20항의 어느 하나의 항에 있어서,허피스 바이러스는 감염된 세포가 면역반응을 촉진하는 것을 억제하지 않으면서, 수상세포에 효율적으로 감염할 수 있는 약화된(attenuated) 허피스 바이러스이고; 약물은 병원성 감염이나 암을 치료하거나 예방하는 방법에 사용하기 위한 용도이고; 전기 방법은 전기 바이러스로 수상세포를 감염시키는 단계를 포함하고;및, 외래유전자는 전기 감염 또는 암과 연관된 항원을 암호화하는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 26항에 있어서,HSV 균주에서 기능성 UL43 유전자, 및/또는 기능성vhs유전자, 또는 비HSV 균주에서 UL43 및/또는vhs의 기능적 등가물이 결핍되며; 및, 선택적으로 HSV 균주에서 추가적으로 기능성 ICP34.5 유전자 또는 비HSV 균주에서 ICP34.5의 기능적 등가물이 결핍되며; 및, 선택적으로 HSV 균주에서 vmw65 유전자의 돌연변이로 인한 결핍으로 전사촉진 활성이 중단되거나 비HSV 균주에서 vmw65 유전자와 등가물인 기능성 유전자의 돌연변이로 인한 결핍으로 전자촉진 활성이 중단되며; 및, 선택적으로 급발성초기 유전자의 적어도 하나가 결핍되는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 27항에 있어서,전기 균주는 HSV 균주이고, 전기 급발성초기 유전자 또는 유전자들은 ICP0, ICP4, ICP22 및 ICP27을 암호화하는 유전자의 하나, 둘, 셋 또는 모든 것임을 특징으로 하는비실험실 주의 전기 유전자를 개체에게 전달하기 위한 약물의 제조를 위한 용도.
- 제 26항 내지 제 28항의 어느 하나의 항에서 정의된 바이러스로 수상세포 또는 마크로파지를 감염시키는 단계 및, 유전자가 감염 또는 암과 연관된 항원을 암호화하는지와 유전자 자체가 치료적 잠재능력을 갖거나 치료적 중계를 위한 목표가 되는지를 결정하기 위하여, 유전자의 폴리펩티드 산물의 항원제시(antigen presentation) 또는 전기 유전자의 발현효과 또는 병원성 감염 또는 암의 표현형을 모니터링하는 단계를 포함하는, 유전자가 병원성 감염 또는 암과 연관된 항원을 암호화하는지를 측정하는 방법.
- (ⅰ) 선택적으로, 숙주로부터 비실험실 바이러스 주를 분리하는 단계;(ⅱ) 전기 비실험실 바이러스 주를 제공하는 단계;(ⅲ) 제 2항의 (c) 또는 (d) 혹은 제 17항의 (d) 또는 (e)에서 정의된 특성의 하나 또는 그 이상의 측면에서 전기 바이러스의 특성을 평가하는 단계; 및 선택적으로,(ⅳ) 바람직한 성질을 갖는 변이 바이러스 주를 선별하는 단계를 포함하는,비실험실 바이러스 주가 제 1항 내지 제 29항의 어느 하나의 항에서 정의된 변이 균주로의 변이가 적합한지를 측정하는 방법.
- (ⅰ) 선택적으로, 숙주로부터 비실험실 바이러스 주를 분리하는 단계;(ⅱ) 종양세포의 하나 또는 그 이상의 종류에서 바이러스의 성장을 평가하는 단계; 및 선택적으로,(ⅲ) 높은 성장속도를 나타내는 변이 바이러스 주를 선별하는 단계를 포함하는, 비실험실 바이러스 주가 제 1항 내지 제 15항의 어느 하나의 항에서 정의된 변이된 종양분해 균주(oncolytic strain)로의 변이가 적합한지를 측정하는 방법.
- 제 31항에 있어서,바이러스는 제 4항 내지 제 7항의 어느 하나의 항에서 정의된 것임을 특징으로 하는비실험실 바이러스 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- (ⅰ) 비실험실 바이러스 주, 또는 선택적으로 제 31항 또는 제 32항의 단계(ⅱ)에 따른 방법에 의하여 선별된 균주를 제공하는 단계;(ⅱ) 종양분해를 하도록 전기 균주를 변이시키는 단계; 및(ⅲ) 전기 변이된 종양분해 비실험실 주가 종양세포를 죽이는 능력을 평가하는 단계; 및 선택적으로(ⅳ) 추가적인 변이를 위한 고종양 세포-죽이는 능력을 나타내는 균주를 선별하는 단계; 및 선택적으로,(ⅴ) 추가적인 변이를 수행하는 단계를 포함하는, 비실험실 바이러스 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- 제 33항에 있어서,바이러스는 제 4항 내지 제 7항의 어느 하나의 항에서 정의된 것임을 특징으로 하는비실험실 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- 제 33항에 있어서,바이러스는 허피스 바이러스이고, HSV 균주에서 ICP34.5, ICP6 및 티미딘 키나제를 암호화하는 유전자로부터 선택된 하나 또는 그 이상의 유전자가 비기능적이 되도록 변이되거나; 또는 비HSV 균주에서 전기 HSV 유전자 또는 유전자들의 등가물인 유전자 또는 유전자들이 비기능적이 되도록 변이되는비실험실 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- 제 33항 내지 제 35항의 어느 하나의 항에 있어서,전기 변이된 종양분해 비실험실 주가 종양세포를 죽이는 능력은, 비기능적이 된 전기 유전자나 유전자들과 동일한 유전자를 갖는 참조 실험실 주가 종양세포를 죽이는 능력과의 비교에 의하여 측정되는비실험실 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- 제 36항에 있어서,비실험실 주는 HSV 균주이고, 참조균주는 HSV 균주 17+, HSV 균주 F 또는 HSV 균주 KOS인 것을 특징으로 하는비실험실 주가 변이된 종양분해 균주로의 변이가 적합한지를 측정하는 방법.
- (ⅰ) 제 1항 내지 제 15항의 어느 항에서 정의된 변이된 종양분해 비실험실 주를 제공하는 단계;(ⅱ) 외래유전자인 전기 유전자를 바이러스내로 삽입하는 단계; 및,(ⅲ) 전기 변이된 종양분해 비실험실 주가 종양세포를 죽이는 능력과 단계 (ⅰ)에서 제공된 최초 균주의 능력을 비교하여 평가하는 단계를 포함하는, 유전자가 바어러스의 항종양 효과를 증진시키는지를 측정하는 방법.
- (ⅰ) 숙주로부터 바이러스의 비실험실 주를 분리하는 단계;(ⅱ) 선택적으로, 제 33항에서 수행된 변이의 적합성을 측정하는 단계; 및(ⅲ) 전기 균주를 종양분해하도록 변이시키는 단계 및 선택적으로,(ⅳ) 추가적인 변이를 수행하는 단계를 포함하는, 변이된 종양분해 비실험실 바이러스 주를 생산하는 방법.
- 제 39항에 있어서,최종적인 변이된 종양분해 비실험실 바이러스는 제 2항 내지 제 15항의 어느 하나의 항에서 정의된 것임을 특징으로 하는변이된 종양분해 비실험실 바이러스 주를 생산하는 방법.
- (ⅰ) 비실험실 바이러스 주를 제공하는 단계;(ⅱ) 전기 균주를 복제능력이 없도록 변이시키는 단계 및,(ⅲ) 외래유전자를 삽입하는 단계를 포함하는, 변이된 비실험실 바이러스 주를 생산하는 방법.
- 제 41항에 있어서,최종적인 변이된 비실험실 바이러스 주는 제 16항 내지 제 29항의 어느 하나의 항에서 정의된 것임을 특징으로 하는변이된 비실험실 바이러스 주를 생산하는 방법.
- 제 1항 내지 제 15항의 어느 하나의 항에서 정의된 변이된 종양분해 비실험실 바이러스 주.
- 제 16항 내지 제 29항의 어느 하나의 항에서 정의된 외래유전자를 포함하는 변이된 비실험실 바이러스 주.
- 허피스 바이러스 주로 제 43항 또는 제 44항에 따른 변이된 비실험실 바이러스 주.
- 허피스 단순포진 바이러스(HSV) 균주로 제 45항에 따른 변이된 비실험실 바이러스 주.
- 제 22항에 따른 방법에 의한, 말초신경계 질병과 연관된 표현형 또는 말초신경계 질병과 관련있는 말초신경계 세포에 효과가 있음이 확인된 유전자, 또는 전기 유전자에 의하여 암호화되는 유전자 산물의 말초신경계 질병의 치료를 위한 약물의 제조를 위한 용도.
- 제 23항에 따른 방법에 의한, 중추신경계 질병과 연관된 표현형 또는 중추신경계 질병과 관련있는 중추신경계 세포에 효과가 있음이 확인된 유전자, 또는 전기 유전자에 의하여 암호화되는 유전자 산물의 중추신경계 질병의 치료를 위한 약물의 제조를 위한 용도.
- 제 29항에 따른 방법에 의한, 병원성 감염 또는 암과 연관된 항원을 암호화하는 것으로 확인된 유전자, 또는 전기 유전자에 의하여 암호화되는 항원의 전기감염 또는 암의 치료 또는 예방을 위한 약물의 제조를 위한 용도.
- 제 30항 내지 제 42항의 어느 하나의 항에 따른 방법에 의하여 동정(identification)되거나 전기 방법에 따라 생성된 비실험실 바이러스 주.
- 제 38항에 따른 방법에 의하여 바이러스의 항종양 효과를 증진시키는 것으로 확인된 유전자, 또는 전기 유전자에 의하여 암호화되는 유전자 산물의 암의 치료 또는 예방을 위한 약물의 제조를 위한 용도.
- 제 39항 내지 제 42항의 어느 하나의 항에 따른 방법에 의하여 얻어지거나 얻어질 수 있는 변이된 비실험실 바이러스 주.
- 가기탁번호(provisional accession number) 01010209로 유럽종균협회(European Collection of Cell Cultures, ECACC)에 기탁된 HSV1 균주 JS1 또는 이들로부터 유래된 HSV1 균주.
- 제 53항에서 정의되고 제 2항 내지 제 29항의 어느 하나의 항에서 개시된 특성을 갖는 JS1으로부터 유도된 HSV1 균주.
- 제 54항에서 정의되고 기능성 ICP34.5 유전자 및, 선택적으로 기능성 ICP47 유전자가 결핍되도록 변이되고; 및, 선택적으로 GMCSF를 암호화하는 외래유전자를 추가적으로 포함하는, JS1으로부터 변이된 HSV1 균주.
- 제 53항 또는 제 55항의 어느 하나의 항에서 정의된 바이러스를 포함하는 약학조성물.
- 제 53항 내지 제 55항의 어느 하나의 항에서 정의된 바이러스의 사람 또는 동물 몸체의 치료를 위한 용도.
- 제 1항에서 정의된 바이러스의 유효량을 사람에게 투여하는 단계를 포함하는, 전기 사람의 종양을 치료하는 방법.
- 제 16항에서 정의된 바이러스의 유효량을 사람에게 투여하는 단계를 포함하는, 유전자를 전기 사람에게 전달하는 방법.
- 제 21항에서 정의된 바이러스의 유효량을 이를 필요로하는 사람의 말초신경에 투여하는 단계를 포함하는, 말초신경계 질병을 치료하거나 예방하는 방법.
- 제 23항에서 정의된 바이러스의 유효량을 이를 필요로하는 사람에게 투여하는 단계를 포함하는, 중추신경계 질병을 치료하거나 예방하는 방법.
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