Sorrento Therapeutics (NSDQ:SRNE) has received the go-ahead from the Brazilian Health Regulatory Agency (ANVISA) for a Phase 2a study involving its COVI-MSC allogeneic adipose-derived mesenchymal stromal cells.
The company hopes the experimental treatment will benefit patients with so-called “long COVID,” a syndrome linked with a variety of symptoms ranging from fatigue to pulmonary compromise.
The study’s primary outcome measure will be change in six-minute walk distance at day 60.
In addition, the study will several secondary outcome measures, including relief of symptoms, change in pulmonary function and change in biomarker levels at day 30 and day 60
The study will test up to three infusions of COVI-MSC in approximately 60 participants.
“We expect this next Phase 2 study to confirm the clinical benefits for long-hauler patients. Long-hauler syndrome is likely to be the next major challenge for medical systems in a post-COVID era, and we intend to be the leaders in addressing this future unmet need,” said Dr. Henry Ji, CEO of Sorrento, in a statement.
Brazilian regulators authorize Sorrento Phase 2 clinical trial of COVI-MSC in COVID-19 long-haulers
Sorrento Therapeutics (NSDQ:SRNE) has received the go-ahead from the Brazilian Health Regulatory Agency (ANVISA) for a Phase 2a study involving its COVI-MSC allogeneic adipose-derived mesenchymal stromal cells.
The company hopes the experimental treatment will benefit patients with so-called “long COVID,” a syndrome linked with a variety of symptoms ranging from fatigue to pulmonary compromise.
The study’s primary outcome measure will be change in six-minute walk distance at day 60.
In addition, the study will several secondary outcome measures, including relief of symptoms, change in pulmonary function and change in biomarker levels at day 30 and day 60
The study will test up to three infusions of COVI-MSC in approximately 60 participants.
“We expect this next Phase 2 study to confirm the clinical benefits for long-hauler patients. Long-hauler syndrome is likely to be the next major challenge for medical systems in a post-COVID era, and we intend to be the leaders in addressing this future unmet need,” said Dr. Henry Ji, CEO of Sorrento, in a statement.
Filed Under: Oncology
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