NST's agent for molecular imaging of apoptosis wins FDA approval for Phase I/II trials

July 25, 2008 -- NeuroSurvival Technologies Ltd. (Petch-Tikva, Israel), says that the U.S. Food and Drug Administration has issued a "safe to proceed" letter for its APOSENSE [18F]-ML-10 Investigational New Drug application. The company, which goes by the initials NST, develops molecular imaging agents and drugs to identify and target cells undergoing apoptosis. Apoptosis is a genetically-controlled process of cell death, associated with medical disorders in such areas as oncology, neurology and cardiology.

Once APOSENSE molecular probes detect apoptosis-specific changes on the cell membrane, they undergo a change that lets them enter and accumulate within the dying cell from the early stages of the death process. The [18F]-ML-10 is labeled with the radioisotope 18F for molecular imaging of programmed cell death in "real-time" with positron emission tomography (PET).

"This is a major step for our company as we now can expand our APOSENSE clinical program into the largest healthcare market in the world," said Yoram Ashery, CEO of NST NeuroSurvival Technologies. "Initial clinical data for our [18F]-ML-10 compound for molecular imaging of apoptosis suggest that we may be able to deliver on the promise of personalized medicine by using real-time images of cell death to monitor disease activity and patient response to treatment."

Pre-clinical studies with [18F]-ML-10 and other APOSENSE compounds showed selective uptake in apoptotic cells in a variety of disease models, including solid tumors undergoing radio- and chemo-therapy, different ischemic and inflammatory conditions, neuro-degenerative disorders, atherosclerosis, acute myocardial infarction and others.

A phase I clinical study conducted in Europe evaluated the safety, dosimetry and biodistribution of [18F]-ML-10 in normal healthy volunteers, and its suitability for imaging of cell death in the region of the infarct in patients with acute ischemic cerebral stroke. In both parts of the study, the company says, [18F]-ML-10 manifested an excellent safety profile and efficacy in imaging cell death. A phase IIa study was recently initiated in Israel in patients with metastatic brain tumors, a serious complication found in up to 25% of patients with advanced cancer. The study evaluates [18F]-ML-10 in early assessment of response to radiotherapy, compared to MRI which typically can evaluate response only two months or longer after treatment has been completed.

Following the FDA's "safe-to-proceed" letter for the [18F]-ML-10 IND, NST will expand its clinical programs in neurovascular disorders and cancer into the U.S. The first protocol already submitted to the FDA evaluates [18F]-ML-10 in visualizing apoptosis and neurovascular damage in patients with relapsing-remitting multiple sclerosis, as well as the safety of administering [18F]-ML-10. NST intends to submit additional protocols in the near term for evaluating [18F]-ML-10 in detecting and monitoring tumor response to anticancer therapy.

Get All the BioOptics World News Delivered to Your Inbox

Subscribe to BioOptics World Magazine or email newsletter today at no cost and receive the latest news and information.

 Subscribe Now
Related Articles

(SLIDE SHOW) Photonics on the brain

Photonics are helping to measure, manipulate, and follow molecular events in living neurons, which could lead to treatments, cures, and possibly even preventions of brain disorders and diseases.

LightWorks Optical Systems named finalist in high-tech awards program

The Orange County Technology Alliance (OC Tech Alliance) has named optics maker LightWorks Optical Systems as a finalist in the Hardware Device category of their annual High-Tech Innovation Awards ...

NIR spectroscopy instrument assists in monitoring brain injuries

Researchers at the Nałęcz Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of Sciences (IBBE PAS) are developing a near-infrared (NIR) spectroscopy instrument that enabl...

(SLIDESHOW) View the July/August 2013 issue

BLOGS

Neuro15 exhibitors meet exacting demands: Part 2

Increasingly, neuroscientists are working with researchers in disciplines such as chemistry and p...

Why be free?

A successful career contributed to keeping OpticalRayTracer—an optical design software program—fr...

LASER Munich 2015 is bio-bent

LASER World of Photonics 2015 included the European Conferences on Biomedical Optics among its si...

White Papers

Understanding Optical Filters

Optical filters can be used to attenuate or enhance an image, transmit or reflect specific wavele...

How can I find the right digital camera for my microscopy application?

Nowadays, image processing is found in a wide range of optical microscopy applications. Examples ...

CONNECT WITH US

            

Twitter- BioOptics World

Copyright © 2007-2016. PennWell Corporation, Tulsa, OK. All Rights Reserved.PRIVACY POLICY | TERMS AND CONDITIONS