Specialty pharmaceutical company, Tenax Therapeutics, Inc. (NASDAQ:TENX), today announced a clinical development update for its lead candidate, levosimendan.
Tenax Therapeutics, Inc. (TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported a comprehensive clinical development update for its lead candidate levosimendan.
Tenax announced today that it has enrolled 833 patients in the Phase 3 LEVO-CTS trial in cardiac surgery patients. The Company plans to complete the study at an estimated 880 total patients to ensure sufficient powering, and anticipates reaching that total around the end of October based on current enrollment trends.
Tenax also announced that the trial’s Data and Safety Monitoring Board (DSMB) recently completed the final safety review from the first 621 patients enrolled and recommended that the study continue as planned.
Once the Company completes enrollment, follow-up will be conducted on the final patient for 30 days before locking the database to begin the top-line data analysis process. In conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI), the Company now expects to release top-line results near the end of 2016, dependent upon enrollment trends during the next month.
“We are now nearing the completion of enrollment for our Phase 3 LEVO-CTS trial in cardiac surgery, our primary indication for levosimendan, and are pleased to have passed the final safety analysis from the DSMB,” said John Kelley, CEO of Tenax Therapeutics. “Sustained execution by our clinical team has allowed us to significantly increase our enrollment rate in 2016, and we are now poised to complete enrollment at an estimated 880 patients around the end of October, to enable a readout of top-line results near the end of this year. We are singularly focused on completing the remainder of this trial and ensuring the highest quality of data, and believe that levosimendan can provide a significant benefit in this critical care population.”
Following top-line data, full results from the study are expected to be presented at a medical meeting during the first half of 2017. If positive, Tenax would anticipate submitting a New Drug Application to the U.S. Food and Drug Administration during 2017.
The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality. The trial is also measuring secondary endpoints around potential pharmacoeconomic benefits and the incidence rate of LCOS. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA).
The full LEVO-CTS trial design was recently published by the study’s investigators in the American Heart Journal, in an article titled, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study Design of the LEVO-CTS Trial.”
Levosimendan in Septic Shock
Today, Anthony Gordon, M.D., Chair in Anaesthesia and Critical Care, Imperial College London, also presented results from the LeoPARDS (Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis) trial evaluating levosimendan in septic shock at the 29th Annual Congress of the European Society of Intensive Care Medicine (ESICM), held in Milan, Italy.
Results presented by Dr. Gordon show that the levosimendan treatment arm did not achieve the trial’s primary endpoint of reducing the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as the pre-specified secondary endpoints. Based upon the results seen today, Tenax does not anticipate undertaking further development with levosimendan in the septic shock indication.
“While we have not yet received the data from this study, based on today’s presentation, we do not currently plan to move forward with levosimendan in septic shock,” Kelley continued. “We want to thank lead investigator Dr. Anthony Gordon and Imperial College for undertaking this study and enabling our collaboration to provide this important, efficient clinical answer.”
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Tenax Therapeutics, Inc. (NASDAQ:TENX) shares have moved -11.72% on the news thus far today and have traded in the range of $2.04 – 2.43 during the current session. In order to take a look at where the stock might be headed longer term, investors often look to research firms that cover the stock. Sell-side research firms currently have a consensus one-year price target of $11.25 on the stock. This is according to brokerage analysts polled by Thomson Reuters First Call. The sell-side analysts are projecting earnings per share of $0.00 for the next fiscal quarter. For the current year, analysts are predicting earnings of $-0.66 per share according to First Call.
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In looking at where the stock is trading on a technical level, the stock is trading -10.64% away from its 50-day moving average of $2.36. Based on the most recent available data, the equity is -39.18% off of its 52-week high of $3.47 and +8.76% away from its 52-week low which is $1.94.
Today, the stock opened at $2.39 and the last bid at the time of writing stood at $2.11. During the session thus far, the equity dipped down to $2.04 and touched $2.43 as the high point. Tenax Therapeutics, Inc. (NASDAQ:TENX) has a market cap of $59.33M and has seen an average daily volume of 33895 over the past three months.
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