Full Press Release Details
Tenax Therapeutics, Inc. Announces Transformative Acquisition of PH
Expands pipeline into Pulmonary Arterial Hypertension (PAH), a
progressive, fatal orphan disease without a cure
Imatinib, a tyrosine kinase inhibitor (TKI), has been shown to
block critical disease promoting pathways and has demonstrated
improved exercise capacity and hemodynamics in patients with
Acquisition strengthens leadership team with appointment of Dr.
Stuart Rich as Chief Medical Officer
Morrisville, NC, January 19, 2021 - Tenax Therapeutics, Inc.
specialty pharmaceutical company focused on identifying,
developing, and commercializing products for the critical care
market, today announced the acquisition of PH Precision Med (PHPM),
a privately-held clinical stage biotech company focused on
developing imatinib for the treatment of pulmonary arterial
hypertension (PAH). The FDA has granted Orphan Drug Designation for
imatinib for the treatment of PAH, an indication with a high unmet
acquisition expands Tenax's pulmonary hypertension pipeline
with the addition of imatinib, a Phase 3 ready candidate. Imatinib
is a tyrosine kinase inhibitor (TKI) that transformed the treatment
of cancer by blocking the underlying pathways resulting in long
lasting remissions. Subsequent preclinical and clinical studies in
PAH indicate that imatinib may provide antiproliferative and
disease-modifying effects in PAH patients through its ability to
inhibit several growth factors including platelet-derived growth
factor (PDGF). PDGF regulates vascular smooth muscle cell
proliferation in PAH and is thought to be associated with the
disease progression. Multiple clinical studies of imatinib in PAH
patients provide convincing evidence that imatinib can provide
impressive improvements in exercise capacity and hemodynamics in
patients with advanced PAH. The strong efficacy results from these
trials, combined with imatinib's antiproliferative mechanism
action, have raised the possibility that imatinib may work by
modifying the underlying PAH disease process. Pursuant to the
acquisition, Tenax's clincial development plan includes
advancing a delayed release oral formulation of imatinib, designed
to avoid the gastric irritation, into a single pivotal trial
pursuant to the 505(b)(2) pathway.
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, said Anthony DiTonno, Chief Executive
Officer of Tenax. The previous clinical trial designs led to
high dropout rates and raised questions related to safety and
tolerability, which limited further development of imatinib in PAH.
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.
Rich, MD, co-founder of PHDM, has been appointed Chief Medical
Officer of Tenax Therapeutics. Dr. Rich currently serves as
Professor of Medicine at Northwestern University Feinberg School of
Medicine, and Director of the Pulmonary Vascular Disease Program at
the Bluhm Cardiovascular Institute. He previously served as FDA
Cardio-Renal Advisory Committee Member.
DiTonno continued, 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 and its treatments. 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. I am confident
this strengthened team is well positioned to maximize the clinical
potential of imatinib and advance the clinical development of
levosimendan for PH-HFpEF, which together have the potential to
address significant unmet needs and large market
next regularly scheduled Board meeting, Dr. Rich is expected to be
appointed to Tenax's Board of Directors. In addition, in
connection with Tenax's 2021 Annual Meeting of Stockholders,
two additional co-founders of PHPM, Declan Doogan, MD and Michael
Davidson, MD, are expected to be nominated to join to Tenax's
Board of Directors. Dr. Doogan is a drug development executive with
more than 30 years of experience in the pharmaceutical industry.
After retiring from Pfizer in 2007 as the Senior VP Head of World
Drug Development he was Head of R&D at Amarin where he helped
raised $100 million to fund the reorganization leading to
completion of a Phase 3 program and approval for Vascepa. He is
cofounder and Chair of Biohaven (BHVN: NYSE) and co-founder of the
healthy aging company Juvenescence. Dr. Davidson was founder of
Omthera Pharmaceuticals, co-founder of Corvidia Therapeutics, Inc.,
and is currently Chief Executive Officer of New Amsterdam Pharma.
Together they bring extensive experience of successful biotech
development and leadership.
Dr. Rich remarked, This
acquisition by Tenax, a clinical-stage publicly traded company with
a pulmonary hypertension focus, 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 Group 1 and Group 2 pulmonary hypertension with a
precision medicine approach, to allow us to achieve the optimal
treatment effects in our clinical trials. I look forward to joining
the Tenax team to unlock the clinical potential of imatinib for
patients with severe PAH.
connection with his appointment, on January 15, 2021, Dr. Rich was
awarded an option to purchase 250,000 shares of the Company's
common stock. This award was made in accordance with the employment
inducement award exemption provided by Nasdaq Rule 5635(c)(4) and
was therefore not awarded under the Company's stockholder
approved equity plan. The option award will vest as follows: 25%
upon initiation of a Phase 3 trial; 25% upon database lock; 25%