A Medical Device Daily

Arteriocyte (Cleveland) reported the receipt of a fast-track Phase I/II Small Business Innovation Research Grant Award from National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health (NIH).

The grant award is the first installment of the combined $2.5 million grant from the NIH to clinically evaluate the therapeutic feasibility of treating critical limb ischemia with the company's expanded human umbilical cord blood derived stem cell therapy (ALO212) using Arteriocyte's NANEX cell expansion technology. The company's NANEX technology provides for a rapid ex-vivo culturing of hemangioblasts, an early progenitor cell shown to have potential in improving perfusion in ischemic tissues.

The company said the NIH award represents an important step in the commercialization of ALO212, its second stem cell pipeline product candidate, transitioning to clinical stage evaluation. The balance of the funding from the NHLBI is expected to be awarded, contingent on successful completion of the Phase I work.

The NANEX technology, developed by Hai-Quan Mao's research team at Johns Hopkins University (Baltimore), involves electrospun nanofibers that create a synthetic bone marrow niche environment, allowing stem cells to rapidly proliferate while maintaining their undifferentiated stem property. Arteriocyte is developing the NANEX platform technology for potential therapeutic use in a number of chronic and acute care settings including treatments for critical limb ischemia, compartment syndrome, and blood pharming – the rapid expansion of cells for the commercial manufacture of universal donor blood.

Arteriocyte develops stem cell therapies for human clinical applications.

In other grant news, Calypso Medical (Seattle) reported that it has received a $1 million grant from the University of Pennsylvania Health System (Philadelphia) to develop a compatible version of the Calypso 4D Localization System that would enable real-time tumor tracking during proton therapy for cancer treatment. This funding will go toward developing a modified version of the Calypso System, using GPS for the Body technology to function with its current high degree of accuracy in a proton therapy environment.

Calypso's GPS for the Body technology uses tiny electromagnetic transponders placed in or around the tumor to provide precise, continuous information on the location of the tumor during external beam radiation therapy. Any movement by the patient, including internal movement of the tumor, may cause the radiation to miss its intended target and hit adjacent healthy tissue.

The company said that, in contrast to other tumor targeting solutions, its GPS for the Body technology provides continuous tumor position information, objectively and without ionizing radiation, thereby optimizing the delivery of radiation to the tumor and minimizing misapplied radiation to normal tissue.

Proton therapy is an advanced form of external beam radiation whereby protons rather than photons are directed at cancerous tissue. Proton therapy in theory has a significant advantage: protons can be delivered to deposit all of their energy in a single location.

Proton therapy is highly precise and able to deliver higher doses of radiation to the tumor, lower doses of radiation to healthy tissue and a lower whole body dose compared to conventional photon therapy. As a result, when used with continuous targeting technology, proton therapy may demonstrate superior tumor control with reduced post-treatment side effects for a wide range of cancers requiring radiation therapy.

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