“The acquisition of PHPM immediately expands Tenax’s pipeline to include a second de-risked Phase 3 ready candidate with the potential to be the first disease modifying treatment of pulmonary arterial hypertension,” Anthony DiTonno, Tenax’s CEO, said in a press release.
Imatinib is marketed as Gleevec and used to treat certain types of leukemia and other cancers of the blood. It works by blocking the actions of various proteins, including PDGF receptors and c-KIT, that promote the vascular remodeling characteristic of PAH.
PDGF, in particular, signals vascular smooth muscle cells to divide and proliferate, which is thought to hasten the disorder’s progression. By preventing this from happening, imatinib might be able to treat the underlying cause of PAH, rather than addressing its symptoms.
Past clinical studies have shown evidence that imatinib can improve the exercise capacity and blood flow of people with advanced PAH, and at least one effort is underway to deliver the therapy directly to the lungs in an inhaled formulation.
Of note, the U.S. Food and Drug Administration (FDA) has granted imatinib its orphan drug designation for the treatment of PAH, which provides various incentives to commercially develop it.
Following the acquisition, Tenax plans to conduct a pivotal trial with a delayed release oral formulation of imatinib that the company hopes will avoid the gastric irritation currently associated with the medicine.
“We believe that PHPM’s innovative clinical development plan, which includes a novel formulation that mitigates the side effects without diminishing the bioavailability, has the potential to yield positive clinical outcomes in a single pivotal Phase 3 trial requisite for regulatory approval,” DiTonno said.
Of note, as an already approved therapy for cancer, studies evaluating imatinib’s use in PAH can directly enter Phase 3 trials, shortening the amount of time needed to test it in this patient population.
Tenax appointed Stuart Rich, MD, co-founder of PHPM, as its new chief medical officer.
“In addition to this transformative asset, we are also pleased to welcome PHPM’s co-founder Dr. Rich to the Tenax management team. Dr. Rich is a pioneer in the field of pulmonary hypertension [PH] and its treatments,” DiTonno said. “In addition, his many years of experience as an FDA advisory committee member provides Tenax with extraordinary knowledge of pulmonary hypertension disease mechanisms and modern regulatory strategies.”
Rich added that the acquisition “is testament to the PHPM team’s success in developing our novel and highly innovative clinical development plan. We will now focus advancing therapeutic candidates for … pulmonary hypertension with a precision medicine approach, to allow us to achieve the optimal treatment effects in our clinical trials.”
Tenax is also developing a therapy called levosimendan for the treatment of another type of PH known as pulmonary hypertension associated with heart failure and preserved ejection fraction.
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