In groundbreaking nanomedicine research, nanoparticles are zapping tumors in humans

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BOSTON — A team of scientists, engineers and physicians led by Brigham and Women’s Hospital, Dana-Farber Cancer Institute, and Harvard Medical School have found promising effects of a first-in-class targeted cancer drug called BIND-014 in treating solid tumors.

BIND-014 is the first targeted and programmed nanomedicine to enter human clinical studies.

In the study, the researchers demonstrate BIND-014’s ability to effectively target a receptor expressed in tumors to achieve high tumor drug concentrations, as well as show remarkable efficacy, safety and pharmacological properties compared to the parent chemotherapeutic drug, docetaxel (Taxotere).

Groundbreaking

“BIND-014 demonstrates for the first time that it is possible to generate medicines with both targeted and programmable properties that can concentrate the therapeutic effect directly at the site of disease, potentially revolutionizing how complex diseases such as cancer are treated,” said Omid Farokhzad, a physician-scientist at Brigham and Women’s Hospital and study co- senior author.

“Previous attempts to develop targeted nanoparticles have not successfully translated into human clinical studies because of the inherent difficulty of designing and scaling up a particle capable of targeting, long-circulation via immune-response evasion, and controlled drug release,” said Robert Langer, David H. Koch Institute Professor, MIT and study co-senior author.

Clinical evaluation

According to the researchers, the drug is the first of its kind to reach clinical evaluation and demonstrates a differentially high drug concentration in tumors by targeting drug encapsulated nanoparticles directly to the site of tumors.

In the study, the researchers produced data that include pharmacokinetic characteristics consistent with prolonged circulation and controlled drug release with plasma concentrations remaining up to at least 100-fold higher than conventional docetaxel for over 24 hours, as well as up to a 10-fold increase in intratumoral drug concentrations with prolonged and enhanced tumor growth suppression in multiple tumor models compared with conventional docetaxel.

Moreover, initial clinical data in a heavily pretreated patient population with 17 patients with advanced or metastatic solid tumor cancers indicated that BIND-014 displays pharmacological characteristics consistent with preclinical findings of differentiated pharmacokinetics and accumulation at tumor sites with clinical effects seen at doses as low as 20 percent of the normally prescribed docetaxel dose and in cancers in which docetaxel has minimal activity (e.g., cervical cancer).

“The development of BIND-014 demonstrates that drug properties such as solubility, metabolism, plasma binding, biodistribution and target tissue accumulation will no longer be constrained to the same extent by the drug chemical composition. It will also become the function of the physicochemical properties of nanoparticles.” said Farokhzad.

To date, the researchers note that BIND-014 has been administered at doses of up to 75 mg/m2 and dose escalation is ongoing. It has been well-tolerated with no new toxicities observed.

‘Revolutionary.’

The emerging BIND-014 clinical data showing signals of efficacy even at relatively low doses validates the potential for the revolutionary impact of nanomedicines and is a paradigm shift for the treatment of cancer.” said Philip W. Kantoff, MD, chief clinical research officer at DFCI, professor of medicine at Harvard Medical School, and study co-author.

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