Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
Zhittya is developing a family of biological drugs to treat diseases characterized by diminished blood flow, or perfusion, to specific tissues or organs. Perfusion leads to the slow starvation of neurons and initiates Parkinson’s, along with Alzheimer’s disease and multiple sclerosis, according Zhittya’s CEO, Daniel Montano.
The stimulation of new blood vessel growth, what a Zhittya white paper refers to as “therapeutic angiogenesis,” by a biological drug can succeed in overcoming the lack of blood flow in Parkinson’s patients. Zhittya is developing a fibroblast growth factor-1 (FGF-1) protein for the study. The drug is designed to stimulate new blood vessel growth that will in turn remove metabolic waste products and ultimately reestablish normal cellular functions.
Montano said the company has a portfolio of 19 medical indications it is targeting, including coronary heart disease, diabetic foot ulcers, stroke recovery and 14 additional major medical disorders characterized by insufficient blood perfusion.
“The people we use in Mexico comply with U.S. FDA standards, so the data we gather will be acceptable to the FDA, though I’m sure they’ll want more,” Montano told BioWorld. “One issue we have to deal with is that no one has ever done what we are doing. It’s the first in humans, so the FDA obviously is cautious because it’s never been done.”
For the study, three ascending doses will be tested in patients with mild to moderately severe Parkinson’s. No placebo will be used.
The company’s biological growth factor has shown it can stop the decline and enhance motor skills of animals, Montano said. The animal data were acceptable to Cofepris to clear a phase I trial. Plus, cost is always a consideration.
“If we’re wrong, we did it for one-fourth the price,” he added.
Zhittya, the Ukrainian word for “life,” also has an application to test its FGF-1 in Mexico to treat amyotrophic lateral sclerosis. It plans to file applications to test it in patients with chronic stroke and major depressive disorder. Montano said all the indications the company is pursuing can be classified as unmet medical needs.
Others are using FGF-1 in their work, including Trefoil Therapeutics Inc.’s TTHX-1114, an engineered form of FGF-1 to restore lost vision in patients with corneal diseases by regenerating corneal tissue. Hutchison China Meditech Ltd., of Hong Kong, has surufatinib, a combination of an FGF-1 receptor antagonist, a CSF-1 antagonist and a pan-VEGF receptor antagonist, in a phase III trial for treating pancreatic neuroendocrine tumors.
Cambridge Research Biochemicals Ltd. and Leidos Biomedical Research Inc., of Frederick, Md., are developing reagents to evaluate eFGF-1, a compound that can promote repair and regeneration of damaged tissues such as those involved in Fuchs dystrophy.
Incyte Corp., of Wilmington, Del., is using pemigatinib, an FGF-1/2/3 receptor antagonist to treat cholangiocarcinoma. Updated phase II data from last fall showed a 36% objective response rate and median progression-free survival of 6.9 months.
Las Vegas-based Zhittya, which has 17 employees, subcontracts everything it possibly can, according to Montano.
“I’m not a big believer in overhead or fixed expenses,” Montano said. “Almost everything in biotech can be subcontracted.”
Montano said he put $26 million into the company, which also received funding from “a small group of people for a long time that believe in what we’re doing.”
In late January, Zhittya signed a $151.5 million international marketing partnership agreement with Regenerative Medicine of Latin America Inc. for the exclusive rights to market and sell all biological drugs developed by Zhittya during a 30-year time period. The payments include an initial up-front payment valued at $76.5 million with the additional $75 million to be amortized through future milestone payments.