Healios Focusing on Stem Cell Trials in Asia

At the Biotech Showcase in San Francisco, the Investing News Network (INN) spoke with Healios’ (TSE:4593) director, David Smith, about its stem cell trials and what the future holds for the company.

Stroke and acute respiratory distress syndrome are two of the company’s main focuses. Another program is for liver, backed by Healios’ organ-bud technology, while AMD is Healios’ ocular regeneration program. Smith added the company will continue to acquire new licenses that drive the company’s portfolio in certain areas.

Healios currently has a pivotal trial for ischemic stroke, which has 220 patients: half are on the active and the other half are on the placebo. It’s expected to finish patient enrollment around the end of 2019, and means the trial should finish late 2020 or early 2021.

This indication has Sakigake designation, which is Japan’s version of Breakthrough Therapy Designation from the US Food and Drug Administration. This gives the company the ability to submit the application for approval and get rapid review.

If approved, around 60,000 patients in Japan would fit the criteria of this drug and revenue could start building up in 2022 onwards. The other trial is for acute respiratory distress syndrome (ARDS), with 30 patients, broken up into 20 on the treatment and 10 with the standard of care.

Athersys (NASDAQ:ATHX), Healios’ partner, released data on its exploratory study for ARDS on January 24, which included positive results from its exploratory clinical study for the MultiStem cell therapy for acute respiratory distress syndrome. The MultiStem treatment group had a lower mortality rate, high amount of ventilator-free days, higher amount of ICE-free days and more.

For Healios’ initiative on treating liver disease, the company is pursuing 3D organs to improve liver function. The technique the company uses brings vascular endothelial cells, Induced Pluripotent Stem Cells and mesenchymal stem cells to develop an organ bud. This could be implanted anywhere in the body that has high vascularization, Smith said. He adding there is already impressive mice models on this data.

The MultiStem product is in-licensed from Athersys. Healios is also negotiating with Athersys for the option to license the drug for indications in China, expanding the platform further.

Smith said the company’s biggest focus is using the Japanese market to grow the entire business. Although, Smith added “the value to the company is driven by having global rights.”

Healios began from licensing intellectual property from the Riken Institute, a research institute in Japan. Healios continues to negotiate and acquire licenses and products from other companies or research institutions, and managing other partnerships. All of these strategies has brought the company to have a number of products around stem cells, Smith said.

On the finance side, Smith said the company has a relatively low burn rate. Healios’ biggest investor is still its founder and CEO Dr. Hardy Kagimoto.

Healios doesn’t currently have any future plans to list on another exchange, but will continue its initiatives to drive its stem cell pipeline in Japan and, ultimately, globally. For investors interested in more news from Healios, follow on the company’s site.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.