JPWO2020243745A5 - - Google Patents
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本発明の特定の実施形態が本明細書に例示され、詳細に記載されているが、本発明はこれらに限定されない。上記の詳細な説明は、本発明の例示として提供されるものであり、本発明の何らかの限定を構成するとして解釈されるべきではない。改変は当業者に明らかであり、本発明の精神から逸脱しない全ての改変は、添付の特許請求の範囲の範囲に含まれることが意図される。
以下、本発明の実施形態を示す。
[1]癌性腫瘍を有する対象を処置する方法であって、1種以上の追加のがん治療と組み合わせた、ヘッジホッグ阻害剤(HHI)の対象への一時的な投与を含む、方法。
[2]ヘッジホッグ阻害剤(HHI)を1種以上の追加のがん治療と組み合わせてがん患者に一時的に投与する方法であって、HHIの投与が、臨床的に有意な、有害な線維芽細胞の枯渇を開始する前に中止される、方法。
[3]HHIが、少なくとも1種の追加のがん治療の実施前に投与される、[1]又は[2]に記載の方法。
[4]HHIの投与が、追加のがん治療のうちの少なくとも1種の中止前に中止される、[1]から[3]のいずれか一に記載の方法。
[5]追加のがん治療のうちの少なくとも1種が全身に送達される療法である、[1]から[4]のいずれか一に記載の方法。
[6]全身に送達される療法が化学療法、標的療法又は免疫療法である、[5]に記載の方法。
[7]追加のがん治療が、化学療法薬(CTA)の投与であり、且つ、HHIが、CTAを投与する前に投与される、[5]に記載の方法。
[8]HHIの投与がCTAの中止前に中止される、[7]に記載の方法。
[9]腫瘍が線維性腫瘍である、[1]から[8]のいずれか一に記載の方法。
[10]腫瘍が固形腫瘍である、[1]から[9]のいずれか一に記載の方法。
[11]腫瘍が高い間質量を有する、[1]から[10]のいずれか一に記載の方法。
[12]HHIが間質量を低減させる、[1]から[11]のいずれか一に記載の方法。
[13]HHIが、腫瘍内又は腫瘍周辺の血管新生を誘導する、[1]から[12]のいずれか一に記載の方法。
[14]HHIがその後に投与されるCTAの腫瘍取込みを改善する、[1]から[13]のいずれか一に記載の方法。
[15]HHIの投与が、間質の更なる低減が停止されるように又は臨床的に有意でないように中止される、[1]から[14]のいずれか一に記載の方法。
[16]HHIの投与が、腫瘍線維芽細胞の更なる枯渇が停止されるように又は臨床的に有意でないように中止される、[1]から[15]のいずれか一に記載の方法。
[17]HHIの投与が追加のがん治療の効果を改善するが、臨床的に有意な腫瘍成長を促進する前に中止される、[1]から[16]のいずれか一に記載の方法。
[18]HHIの投与が臨床的に有意なHHI誘導性転移をその後に開始しないように、HHIの投与が中止される、[1]から[17]のいずれか一に記載の方法。
[19]HHIの投与がその後の腫瘍転移の可能性を著しく増大しないように、HHIの投与が中止される、[1]から[18]のいずれか一に記載の方法。
[20]HHIの投与が、その後に実施されるがん治療の有効性を改善する、[1]から[19]のいずれか一に記載の方法。
[21]改善が、
A)代謝応答、
B)ポジトロン放出断層撮影、
C)基準に従った客観的応答、
D)無増悪生存、
E)全生存、
F)腫瘍マーカーレベルに基づく応答、
G)毒性、及び
H)腫瘍の弾性
のうちの1つ以上により証明される、[20]に記載の方法。
[22]改善が、生存の延長又は無増悪期間の延長により証明される、[20]に記載の方法。
[23]改善が、無増悪生存により証明される、[20]に記載の方法。
[24]がんが、膵がん、食道がん、扁平上皮癌、前立腺がん、結腸がん、乳がん、肝細胞癌、腎がん又は胆管細胞癌である、[1]から[23]のいずれか一に記載の方法。
[25]がんが膵管腺癌(PDAC)である、[1]から[24]のいずれか一に記載の方法。
[26]がんが肝細胞がんである、[1]から[24]のいずれか一に記載の方法。
[27]HHIがSmoアンタゴニストである、[1]から[25]のいずれか一に記載の方法。
[28]SmoアンタゴニストがTAK 441、グラスデギブ、タラデギブ、ソニデギブ、サリデギブ、パチデギブ、BMS833923、LEQ506及びこれらの組合せからなる群から選択される、[27]に記載の方法。
[29]HHIがTAK 441である、[1]~[28]のいずれか一に記載の方法。
[30]CTAが、ゲムシタビン、ナブパクリタキセル、タキソール、イリノテカン、テモゾロミド、カペシタビン、トポテカン、シスプラチン、オキサリプラチン、カルボプラチン、カンプトテシン、シタラビン、フルオロウラシル、シクロホスファミド、エトポシドリン酸塩、テニポシド、ドキソルビシン、ダウノルビシン及びペメトレキセドからなる群から選択される、[26]から[29]のいずれか一に記載の方法。
[31]CTAがナブパクリタキセル、ゲムシタビン及びシスプラチンのうちの1種以上である、[30]に記載の方法。
[32]CTAがナブパクリタキセル及びゲムシタビンのうちの1種以上である、[30]に記載の方法。
[33]HHIの投与経路が、静脈内、経口及び局所からなる群から選択される、[1]から[32]のいずれか一に記載の方法。
[34]追加のがん治療の投与経路が、静脈内、経口及び局所からなる群から選択される、[1]から[33]のいずれか一に記載の方法。
[35]HHI及び追加のがん治療の用量が、生物学的有効用量と最大耐量との間で投与される、[1]から[34]のいずれか一に記載の方法。
[36]患者が、処置サイクルを受け、且つ、追加のがん治療がCTAであり、全又は実質的に全処置サイクル中に投与される、[1]から[35]のいずれか一に記載の方法。
[37]患者が、追加のがん治療の処置サイクルを受け、且つ、HHIが、全処置サイクルより短いサイクル中に投与される、[36]に記載の方法。
[38]患者が、サイクル中に追加のがん治療の処置を受けており、且つ、1つ以上の用量のHHIが、初期処置サイクル前及びそのサイクル中にのみ投与される、[1]から[37]のいずれか一に記載の方法。
[39]1つ以上の用量のHHIが、1~5サイクルの化学療法の1~10日前にのみ投与される、[37]又は[38]に記載の方法。
[40]1つ以上の用量のHHIが、第3のサイクルまでに投与される、[39]に記載の方法。
[41]各サイクルが28日であり、且つ、HHIがサイクル1~3の各サイクルの-4日~-1日及び10~13日目に投与され、且つ、CTAが28日ごとに1日目、8日目及び15日目に投与される、[37]から[40]のいずれか一に記載の方法。
[42]HHIが800mg用量のTAK 441である、[41]に記載の方法。
[43]CTAが、1000mg/m
2
のゲムシタビン及び125mg/m
2
のナブパクリタキセルのうちの1種以上から選択される、[41]又は[42]に記載の方法。
[44]1つ以上の用量の追加のがん治療の後に、1つ以上の用量のチェックポイント阻害剤(CI)が続く、[1]から[43]のいずれか一に記載の方法。
[45]CTAが1つ以上の用量で投与されるチェックポイント阻害剤(CI)である、[1]から[29]のいずれか一に記載の方法。
[46]CIの投与経路が、静脈内、経口又は局所からなる群から選択される、[44]又は[45]に記載の方法。
[47]1つ以上の用量のCIが、生物学的有効用量と最大耐量との間で投与される、[44]~[46]のいずれか一に記載の方法。
[48]CIがCTLA 4阻害剤、PD1阻害剤又はPDL1阻害剤である、[44]から[47]のいずれか一に記載の方法。
[49]CIが、トレメリムマブ、イピリムマブ、デュルバルマブ、ニボルマブ、ペムブロリズマブ、アテゾリズマブ、セミプリマブ、AGEN1884、AGEN2034又はAGEN1181である、[48]に記載の方法。
[50]CIがイピリムマブである、[49]に記載の方法。
[51]患者がサイクルで処置を受け、且つ、1つ以上の用量のCIが、処置サイクルの終了近く又は開始近くにのみ投与される、[44]から[50]のいずれか一に記載の方法。
[52]1つ以上の用量のCIが処置サイクル終了の7日以内にのみ投与される、[51]に記載の方法。
[53]1つ以上の用量のCIが、少なくとも1、2又は3処置サイクル後にのみ投与される、[51]に記載の方法。
[54]サイクルが28日であり、且つ、CIが、サイクル4から開始して各サイクルの1日目及び21日目に投与される、[51]に記載の方法。
[55]CI用量がイピリムマブの3mg/kg IV用量である、[54]に記載の方法。
[56]それを必要とする対象においてがん又はがんの影響を処置又は改善する方法であって、有効量のヘッジホッグ阻害剤(HHI)又はその薬学的に許容される塩、及び化学療法薬(CTA)を対象に投与することを含む、方法。
[57]HHIがTAK 441である、[56]に記載の方法。
[58]CTAがナブパクリタキセルである、[56]又は[57]に記載の方法。
[59]CTAがチェックポイント阻害剤(CI)である、[57]に記載の方法。
[60]チェックポイント阻害剤(CI)の投与を更に含む、[58]に記載の方法。
[61]がんが線維性間質を有する、[56]から[60]のいずれか一に記載の方法。
[62]がんが、膵がん、食道がん、扁平上皮癌、前立腺がん、結腸がん、乳がん、肝細胞癌、腎がん又は胆管細胞癌である、[56]から[61]のいずれか一に記載の方法。
[63]がんが膵管腺癌(PDAC)である、[56]から[62]のいずれか一に記載の方法。
[64]がんが肝細胞癌である、[56]から[62]のいずれか一に記載の方法。
[65]処置の効果が腫瘍退縮により測定される、[56]から[64]のいずれか一に記載の方法。
[66]処置の効果が、
A)フルオロデオキシグルコース(FDG)により測定される代謝応答、
B)EORTC基準に従ったPET、
C)RECIST(固形癌効果判定基準)基準に従った客観的応答、
D)無増悪生存、
E)全生存、
F)腫瘍マーカー(例えばCA 19.9)レベルに基づく応答、
G)毒性(例えば有害事象用語共通毒性規準、国立がん研究所、第4.03版(NCI CTCAE v4.03)に従った)及び
H)腫瘍の弾性
からなる群のうちの1つ以上から選択される腫瘍成長阻害モデルにおける腫瘍成長阻害因子により測定される、[56]から[65]のいずれか一に記載の方法。
Although specific embodiments of the invention have been illustrated and described in detail herein, the invention is not so limited. The above detailed descriptions are provided as exemplary of the present invention and should not be construed as constituting any limitation of the invention. Modifications will be apparent to those skilled in the art, and all modifications that do not depart from the spirit of the invention are intended to be included within the scope of the appended claims.
Embodiments of the present invention are shown below.
[1] A method of treating a subject with a cancerous tumor, the method comprising interim administration to the subject of a hedgehog inhibitor (HHI) in combination with one or more additional cancer therapies.
[2] A method of temporarily administering a hedgehog inhibitor (HHI) to a cancer patient in combination with one or more additional cancer treatments, wherein administration of the HHI results in clinically significant adverse effects. A method that is terminated prior to initiating fibroblast depletion.
[3] The method of [1] or [2], wherein the HHI is administered prior to administration of at least one additional cancer treatment.
[4] The method of any one of [1] to [3], wherein administration of HHI is discontinued prior to discontinuation of at least one additional cancer therapy.
[5] The method of any one of [1] to [4], wherein at least one of the additional cancer therapies is a systemically delivered therapy.
[6] The method of [5], wherein the systemically delivered therapy is chemotherapy, targeted therapy or immunotherapy.
[7] The method of [5], wherein the additional cancer treatment is administration of a chemotherapeutic agent (CTA), and the HHI is administered prior to administering the CTA.
[8] The method of [7], wherein administration of HHI is discontinued prior to discontinuation of CTA.
[9] The method of any one of [1] to [8], wherein the tumor is a fibrous tumor.
[10] The method of any one of [1] to [9], wherein the tumor is a solid tumor.
[11] The method of any one of [1] to [10], wherein the tumor has a high intermass.
[12] The method of any one of [1] to [11], wherein the HHI reduces interstitial mass.
[13] The method of any one of [1] to [12], wherein HHI induces intratumoral or peritumoral angiogenesis.
[14] The method of any one of [1] to [13], wherein HHI improves tumor uptake of subsequently administered CTA.
[15] The method of any one of [1] to [14], wherein administration of HHI is discontinued such that further reduction in stroma is halted or is not clinically significant.
[16] The method of any one of [1] to [15], wherein administration of HHI is discontinued such that further depletion of tumor fibroblasts is halted or is not clinically significant.
[17] The method of any one of [1] to [16], wherein administration of HHI ameliorates the efficacy of additional cancer therapy but is discontinued prior to promoting clinically significant tumor growth .
[18] The method of any one of [1] to [17], wherein administration of HHI is discontinued such that administration of HHI does not subsequently initiate clinically significant HHI-induced metastasis.
[19] The method of any one of [1] to [18], wherein administration of HHI is discontinued so that administration of HHI does not significantly increase the likelihood of subsequent tumor metastasis.
[20] The method of any one of [1] to [19], wherein administration of HHI improves the efficacy of subsequently administered cancer therapy.
[21] The improvement is
A) metabolic response,
B) positron emission tomography,
C) an objective response according to criteria;
D) progression-free survival,
E) overall survival;
F) response based on tumor marker levels;
G) Toxicity, and
H) Tumor elasticity
The method of [20], as evidenced by one or more of:
[22] The method of [20], wherein improvement is evidenced by prolonged survival or prolonged time to progression.
[23] The method of [20], wherein improvement is evidenced by progression-free survival.
[24] The cancer is pancreatic cancer, esophageal cancer, squamous cell carcinoma, prostate cancer, colon cancer, breast cancer, hepatocellular carcinoma, renal cancer or cholangiocarcinoma, [1] to [23] The method according to any one of
[25] The method of any one of [1] to [24], wherein the cancer is pancreatic ductal adenocarcinoma (PDAC).
[26] The method of any one of [1] to [24], wherein the cancer is hepatocellular carcinoma.
[27] The method of any one of [1] to [25], wherein HHI is a Smo antagonist.
[28] The method of [27], wherein the Smo antagonist is selected from the group consisting of TAK 441, Gladegib, Taladegib, Sonidegib, Salidegib, Pachidegib, BMS833923, LEQ506 and combinations thereof.
[29] The method of any one of [1]-[28], wherein HHI is TAK 441.
[30] CTA is gemcitabine, nab-paclitaxel, taxol, irinotecan, temozolomide, capecitabine, topotecan, cisplatin, oxaliplatin, carboplatin, camptothecin, cytarabine, fluorouracil, cyclophosphamide, etoposide phosphate, teniposide, doxorubicin, daunorubicin and The method of any one of [26] to [29], selected from the group consisting of pemetrexed.
[31] The method of [30], wherein the CTA is one or more of nab-paclitaxel, gemcitabine and cisplatin.
[32] The method of [30], wherein the CTA is one or more of nab-paclitaxel and gemcitabine.
[33] The method of any one of [1] to [32], wherein the administration route of HHI is selected from the group consisting of intravenous, oral and topical.
[34] The method of any one of [1] to [33], wherein the administration route of the additional cancer therapy is selected from the group consisting of intravenous, oral and topical.
[35] The method of any one of [1] to [34], wherein the doses of HHI and additional cancer therapy are administered between the biologically effective dose and the maximum tolerated dose.
[36] Any one of [1] to [35], wherein the patient undergoes treatment cycles and the additional cancer therapy is CTA and is administered during all or substantially all treatment cycles the method of.
[37] The method of [36], wherein the patient receives an additional cancer therapy treatment cycle and the HHI is administered during a shorter cycle than the entire treatment cycle.
[38] the patient is receiving additional cancer therapy treatment during the cycle, and one or more doses of HHI are administered only before and during the initial treatment cycle, from [1] The method according to any one of [37].
[39] The method of [37] or [38], wherein the one or more doses of HHI is administered only 1-10 days prior to 1-5 cycles of chemotherapy.
[40] The method of [39], wherein one or more doses of HHI are administered by the third cycle.
[41] Each cycle is 28 days, and HHI is administered on days -4 to -1 and 10-13 of each cycle in cycles 1-3, and CTA is 1 day every 28 days The method of any one of [37] to [40], administered on days 1, 8 and 15.
[42] The method of [41], wherein the HHI is an 800 mg dose of TAK 441.
[43] The method of [41] or [42], wherein the CTA is selected from one or more of 1000 mg/m 2 gemcitabine and 125 mg/m 2 nab-paclitaxel.
[44] The method of any one of [1] to [43], wherein one or more doses of additional cancer treatment is followed by one or more doses of a checkpoint inhibitor (CI).
[45] The method of any one of [1] to [29], wherein the CTA is a checkpoint inhibitor (CI) administered in one or more doses.
[46] The method of [44] or [45], wherein the administration route of CI is selected from the group consisting of intravenous, oral or topical administration.
[47] The method of any one of [44]-[46], wherein one or more doses of CI are administered between the biologically effective dose and the maximum tolerated dose.
[48] The method of any one of [44] to [47], wherein CI is a CTLA 4 inhibitor, PD1 inhibitor or PDL1 inhibitor.
[49] The method of [48], wherein CI is tremelimumab, ipilimumab, durvalumab, nivolumab, pembrolizumab, atezolizumab, semiplimab, AGEN1884, AGEN2034, or AGEN1181.
[50] The method of [49], wherein CI is ipilimumab.
[51] Any one of [44] to [50], wherein the patient receives treatment in cycles and the one or more doses of CI are administered only near the end or near the beginning of the treatment cycle Method.
[52] The method of [51], wherein the one or more doses of CI is administered only within 7 days of the end of the treatment cycle.
[53] The method of [51], wherein one or more doses of CI is administered only after at least 1, 2, or 3 treatment cycles.
[54] The method of [51], wherein the cycle is 28 days and CI is administered on days 1 and 21 of each cycle starting with cycle 4.
[55] The method of [54], wherein the CI dose is 3 mg/kg IV dose of ipilimumab.
[56] A method of treating or ameliorating cancer or the effects of cancer in a subject in need thereof, comprising an effective amount of a hedgehog inhibitor (HHI) or a pharmaceutically acceptable salt thereof, and chemotherapy A method comprising administering a drug (CTA) to a subject.
[57] The method of [56], wherein HHI is TAK441.
[58] The method of [56] or [57], wherein the CTA is nab-paclitaxel.
[59] The method of [57], wherein the CTA is a checkpoint inhibitor (CI).
[60] The method of [58], further comprising administration of a checkpoint inhibitor (CI).
[61] The method of any one of [56] to [60], wherein the cancer has fibrous stroma.
[62] The cancer is pancreatic cancer, esophageal cancer, squamous cell carcinoma, prostate cancer, colon cancer, breast cancer, hepatocellular carcinoma, renal cancer or cholangiocellular carcinoma, [56] to [61] The method according to any one of
[63] The method of any one of [56] to [62], wherein the cancer is pancreatic ductal adenocarcinoma (PDAC).
[64] The method of any one of [56] to [62], wherein the cancer is hepatocellular carcinoma.
[65] The method of any one of [56] to [64], wherein efficacy of treatment is measured by tumor regression.
[66] the effect of treatment is
A) Metabolic response measured by fluorodeoxyglucose (FDG),
B) PET according to EORTC standards,
C) Objective response according to RECIST (Solid Tumor Efficacy Criteria) criteria,
D) progression-free survival,
E) overall survival;
F) response based on tumor marker (e.g. CA 19.9) levels,
G) Toxicity (e.g. according to Common Toxicity Criteria for Adverse Event Terminology, National Cancer Institute, Version 4.03 (NCI CTCAE v4.03)) and
H) Tumor elasticity
The method of any one of [56] to [65], as measured by a tumor growth inhibition factor in a tumor growth inhibition model selected from one or more of the group consisting of:
Claims (28)
1つ以上の追加の癌治療と組み合わせた、ヘッジホッグ阻害剤(HHI)としてTAK-441の対象への一時的な投与を含み、
前記1つ以上の追加の癌治療が、1以上のサイクルの処置で施され、該1以上のサイクルの処置が、
(a)前記1つ以上の追加の癌治療の実施前のTAK-441の投与;
(b)前記1つ以上の追加の癌治療の実施;及び
(c)前記1以上のサイクルの処置が完了するまでのステップ(a)及びステップ(b)の繰り返し;
を含む処置レジメンを含み、且つ、
前記TAK-441の投与が、全てのサイクルの処置を通して継続しない、
前記方法。 A method of treating a subject with a cancerous tumor, comprising:
including episodic administration to a subject of TAK-441 as a hedgehog inhibitor (HHI) in combination with one or more additional cancer treatments;
the one or more additional cancer therapies are administered in one or more cycles of treatment, wherein the one or more cycles of treatment comprise:
(a) administration of TAK-441 prior to administration of said one or more additional cancer treatments;
(b) administering said one or more additional cancer treatments; and
(c) repeating steps (a) and (b) until said one or more cycles of treatment are complete;
A treatment regimen comprising
the administration of TAK-441 does not continue through all cycles of treatment;
the aforementioned method.
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CA (1) | CA3141072A1 (en) |
IL (1) | IL288591A (en) |
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US20170326118A1 (en) * | 2001-07-02 | 2017-11-16 | Sinan Tas | Drug treatment of tumors wherein hedgehog/smoothened signaling is utilized for inhibition of apoptosis of tumor cells |
EP2470173B1 (en) * | 2009-08-25 | 2016-04-27 | Abraxis BioScience, LLC | Combination therapy with nanoparticle compositions of taxane and hedgehog inhibitors |
RU2016103126A (en) | 2010-06-07 | 2018-11-22 | АБРАКСИС БАЙОСАЙЕНС, ЭлЭлСи | METHODS OF COMBINED THERAPY FOR TREATMENT OF PROLIFERATIVE DISEASES |
US10220091B2 (en) * | 2013-04-04 | 2019-03-05 | The General Hospital Corporation | Combination treatments with sonic hedgehog inhibitors |
WO2015073691A1 (en) * | 2013-11-14 | 2015-05-21 | The Board Of Trustees Of The Leland Stanford Junior University | Methods for treating cancer by activation of bmp signaling |
WO2016141084A1 (en) * | 2015-03-03 | 2016-09-09 | The Board Of Trustees Of The Leland Stanford Junior University | Producing mesodermal cell types and methods of using the same |
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