Diffusion Pharmaceuticals Completes Dosing in Altitude Trial

Diffusion Pharmaceuticals Inc. recently announced the final participant has completed dosing in its Altitude Trial.

The Altitude Trial is a double-blind, randomized, placebo-controlled crossover study, designed to evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of arterial blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions at a simulated altitude of 15,000 feet above sea level. A total of 30 volunteers were enrolled in the trial with each participant serving as their own control by completing the experiment twice in a random, blinded order, once after placebo administration and the other time after receiving a single dose of TSC at one of three dose levels.

“I would like to express our gratitude to the esteemed investigators and the participants in this clinical study,” said Chris Galloway, MD, Chief Medical Officer of Diffusion. “We look forward to obtaining topline results within the next two months, and believe that positive results, if obtained, will support the broad clinical potential of TSC to enhance oxygenation across a spectrum of conditions complicated by hypoxia.”

Topline, unblinded data from the Altitude Trial will be available within two months. In the meantime, the clinical investigators have submitted two presentation abstracts for the Undersea & Hyperbaric Medical Society’s Annual Scientific Meeting in Reno, NV, scheduled for May 22 to 26 based on blinded, aggregated (placebo and treatment) physiology data from the first fifteen participants in the study.

The results of the Altitude Trial will be used to further inform the design of clinical trials aimed at supporting the development and approval of TSC as a treatment for conditions complicated by hypoxia. While the company intends to continue developing data to support TSC’s broad potential uses, it recently announced its intent to focus its near-term efforts on evaluating TSC as an adjunct to standard of care in the treatment of hypoxic solid tumors as a first indication.

Diffusion Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. Diffusion’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions, including hypoxic solid tumors. For more information, visit www.diffusionpharma.com.