Oxygen Biotherapeutics stock jumped 16 percent Monday after the Morrisville company announced details of late-stage clinical trials for its cardiovascular drug.
The phase 3 trials for Levosimendan, a drug to prevent and treat cardiac surgery patients at risk of developing low cardiac output syndrome, or LCOS, are to be conducted by Duke University’s Clinicla Research Institute. They will include 760 patients at about 50 major cardiac surgery centers in North American.
Oxygen Bio expects to begin enrolling its first patients later this year. Phase 3 clinical trials are the final phase required before seeking regulatory approval. Oxygen Bio believes Levosimendan targets a $600 million market in the U.S.
In October, the company acquired the rights to Levosimendan for $4.8 million in stock from Phyxius Pharma, a privately held Texas company. It’s stock rose 30 percent in a single day after the deal was announced.
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Oxygen Bio also added three Phyxius Pharma executives to its management team. John Kelly, co-founder and CEO of Phyxius Pharma, became Oxygen Bio’s CEO.
“We are excited to communicate the details of our innovative and efficient trial design , and we look forward to enrolling the first patients in this important trial later this year,” Kelly said in a statement Monday.
Levosimendan has been granted fast-track status by the Food and Drug Administration, a designation that accelerates the review process for drugs that have the potential to offer significant improvement in treatment compared to products already on the market.
Oxygen Bio is also developing several experimental drugs.
It is partnering with Wilmington-based PPD to complete the second phase of clinical trials of Oxycyte, a treatment for traumatic brain injury. The company is also conducting preclinical trials of a substance for healing wounds and sells an over-the-counter cosmetic line, Dermacyte, which is used to treat fine lines and wrinkles.
Oxygen Bio shares closed Monday at $5.50, up 76 cents.