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Project Name
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Novel polymer-conjugated docetaxel nanoparticle ( MaRS )
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Project Information
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Cellax™ is a proprietary and novel polymer-based nanoparticle drug-delivery technology designed to improve the efficacy and safety of cancer therapy by accumulating in solid tumours via the enhanced permeability and retention effect and releasing cytotoxic drugs intracellularly. Cellax delivers docetaxel (DTX), a leading anticancer drug, and in preclinical evaluation has demonstrated superior safety and efficacy compared to approved taxane therapeutics, including Taxotere® (native DTX) and Abraxane® (albumin-bound paclitaxel; the only FDA-approved taxane nanoparticle).
Cellax is prepared by coupling DTX and polyethylene glycol (PEG) to a biocompatible acetylated carboxymethylcellulose (CMC-Ac) polymer, a non-toxic excipient commonly used in pharmaceutical formulations. Cellaxis optimized to self-assemble into defined and stable 120 nm nanoparticles in normal saline. Unlike Taxotere®, Cellax can be administered without detergents or organic solvents.
Compared to Taxotere® and Abraxane®, Cellax increases systemic drug exposure by 40 fold, controls release for sustained exposure, improves the tumour delivery by >5.5 fold and enhances the specificity of biodistribution to the tumour. Cellax interacts with tumour stroma cells and causes >50 percent depletion of α-SMA-positive cells and matrix, key drivers of tumour growth and metastases. Taxotere® and Abraxane® display little to moderate anti-stromal activity. These enhancements significantly improve the safety and efficacy profiles of DTX treatment in multiple orthotopic and metastatic animal models.
Taxane therapies are a multi-billion dollar market. Taxanes are effective anti-cancer drugs indicated for lung, breast, prostate and ovarian cancer, but induce serious side effects in patients, including fluid retention, hypersensitivity reactions, neutropenia, neuropathy, skin toxicity and severe weakness/fatigue.
Worldwide reformulation efforts aim to reduce taxane toxicities while increasing the dose that may be safely administered.The success of Abraxane® suggests that a corresponding DTX formulation, such as Cellax, is more effective and safer, which will generate substantial patient pull and capture a significant portion of the taxane market.
While the Cellax platform is designed to deliver different hydrophobic drugs to solid tumours, the most immediately viable commercial application for the Cellax technology is to deliver docetaxel. Taxotere® and Abraxane® are approved and broadly-indicated taxane formulations that induce distinct side effects.
Based on our preclinical data, we expect that the Cellax docetaxelformulation will induce fewer side effects and exhibit improved anti-tumour activity in taxane-approved cancer indications, and compete for the Taxotere® and Abraxane® markets.
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IPR
A provisional patent application covering the composition-of-matter of Cellax, the self-assembling aspect of the nanoparticle, and the method of synthesis,was filed in the USPTO on February 2, 2011 (US61/438,842) and was converted to a PCT application (PCT/CA2012/000082) on February 1, 2012. A corresponding U.S. patent application (US13/363,822) was also filed on February 1, 2012 to expedite prosecution for the larger U.S. market.
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The project will be expired in three months, for more project information, please contact: services@beijing-ontario.org