Particles of paclitaxel and albumin in combination with bevacizumab against cancer

A nanoparticle, bevacizumab technology, applied in peptide/protein components, antibodies, drug combinations, etc., can solve problems such as affecting albumin transport

Inactive Publication Date: 2009-11-04
ABRAXIS BIOSCI LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, it has been shown that and 80 all strongly inhibit the binding of paclitaxel to albumin, possibly affecting albumin-based transport (Desai et al., EORTC-NCI-AACR, 2004)

Method used

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  • Particles of paclitaxel and albumin in combination with bevacizumab against cancer
  • Particles of paclitaxel and albumin in combination with bevacizumab against cancer
  • Particles of paclitaxel and albumin in combination with bevacizumab against cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0268] Example 1. Administered every three weeks In Phase III studies, compared to improved response and reduced toxicity

[0269] [000237] Significantly lower rates of neutropenia and hypersensitivity reactions, no need for steroid premedication, shorter duration of neuropathy, shorter infusion times, and higher doses.

[0270] [000238] In individuals with metastatic breast cancer (MBC), ABI-007 - the first biologically interacting nab-paclitaxel in the form of nanoparticles without any solvent, and based on Paclitaxel Compare. This Phase III study was conducted to corroborate preclinical studies demonstrating that ABI-007 interacts with Superior efficacy and reduced toxicity compared to Subjects were randomized to a 3-week cycle or ABI-007 260mg / m administered (iv) over a 30-minute period 2 Without predosing (n=229), or given intravenously over a 3-hour period 175mg / m 2 , predosed (n=225). and In contrast, ABI-007 showed a significantly higher response r...

Embodiment 2

[0271] Example 2. In individuals with taxane-refractory metastatic breast cancer, weekly dosing

[0272] [000239] A recent phase II clinical study showed that in individuals with metastatic breast cancer, at a dose of 125 mg / m 2 give weekly (nanoparticle albumin-bound paclitaxel) produces long-term disease control, the patient's disease in the application or Progression despite treatment (ie, the individual is taxane refractory).

[0273] 【000240】 Believed to represent the first biologically interacting composition utilizing a receptor-mediated (gp60) pathway found to be integral to obtaining high intracellular tumor concentrations of the active ingredient, paclitaxel. The phase II study included 75 individuals with taxane-refractory metastatic breast cancer. 125mg / m per week 2 Administered by 30-minute infusion No preadministration of steroids / antihistamines or G-CSF prophylaxis. Subjects received three weekly doses followed by 1 week off, repeated every 28 day...

Embodiment 3

[0281] Example 3. In MDA-MB-435 human tumor xenografts, (ABI-007) synergizes with targeted anti-angiogenic pro-apoptotic peptide (HKP)

[0282][000248] The anti-angiogenic activity of a small synthetic pro-apoptotic peptide consisting of two functional domains has been reported, one targeting the CD 13 receptor (aminopeptidase N) on tumor microvessels and the other functional Domain interferes with mitochondrial membranes after internalization. See, Nat Med. 1999 Sep;5(9):1032-8. Discovery of the second generation dimer peptide CNGRC-GG-d(KLAKLAK) 2 ——Named as HKP (Hunter Killer Peptide), it has improved anti-tumor activity. Due to anti-angiogenic agents such as Exhibiting synergy with cytotoxic agents such as 5-fluorouracil, we evaluated the anti-angiogenic agents HKP and (ABI-007) in combination, Paclitaxel, an albumin nanoparticle, is transported by gp60 receptors in the vascular endothelium (Desai, SABCS 2003).

[0283] [000249] method: with an average tumor vol...

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Abstract

The present invention provides combination therapy methods of treating proliferative diseases (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include, for example, radiation, surgery, administration of chemotherapeutic agents (such as an anti-VEGF antibody), or combinations thereof. Also provided are methods of administering to an individual a drug taxane in a nanoparticle composition based on a metronomic dosing regime.

Description

technical field [0001] [0001] The present invention relates to methods and compositions for the treatment of proliferative diseases comprising the administration of a taxane and at least one other therapeutic agent in combination with other therapeutic modalities for the treatment of proliferative diseases. In particular, the present invention relates to the use of nanoparticles comprising paclitaxel and albumin (e.g. ) in combination with other chemotherapeutic agents or radiotherapy, which can be used to treat cancer. Background technique [0002] [0002] A large number of tumors do not respond to drugs and / or radiation therapy, which is a serious problem in cancer treatment. In fact, despite some advances in the field of chemotherapy, the aforementioned problem is one of the main reasons why many of the most prevalent forms of human cancer remain resistant to effective chemotherapy interventions. [0003] [0003] Currently, one or a combination of three main therapies ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K39/395A61K45/06A61P35/04A61P35/00A61K33/243
CPCA61K33/24A61K31/337A61K45/06A61K39/395A61K31/7072A61K9/0019A61K31/282A61K9/5169A61P35/00A61P35/02A61P35/04A61P43/00A61K33/243A61K2300/00A61K38/38A61K35/00A61K35/04
Inventor N·P·德塞P·孙一雄
Owner ABRAXIS BIOSCI LLC
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