LOS ANGELES, CA — (Marketwired) — 02/11/16 — Endonovo Therapeutics, Inc. (OTCQB: ENDV) (“Endonovo” or the “Company”), an innovative biotechnology company developing bioelectronics-based products and therapies for regenerative medicine, announced it has retained Holland & Knight to prepare and file the paperwork necessary to obtain an orphan drug designation for Endonovo’s proprietary Cytotronics™ product.
Endonovo is requesting the United States Food and Drug Administration (FDA) grant an orphan drug designation to its next-generation, off-the-shelf treatment for Graft-Versus-Host Disease (GVHD) using Cytotronics™ expanded and ex vivo enhanced stem cells from the human umbilical cord.
Orphan drug designation is granted by the FDA to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The designation provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials. The orphan drug designation also would entitle Endonovo to a seven-year period of marketing exclusivity in the United States for the Company’s orphan indication should Endonovo receive FDA approval for the treatment of GVHD. Therapies with orphan drug status are also not subject to a prescription drug user fee for the orphan indication.
Upon the FDA granting Endonovo an orphan drug designation for the treatment of GVHD, the Company intends to demonstrate the safety and effectiveness of our Cytotronics™ product through adequate and well-controlled studies satisfying the FDA’s requirements for Premarket Approval.
Alan Collier, President and CEO, commented, this is the first of many steps for Endonovo receiving FDA approval to market its Cytotronics™ product for the treatment of GVHD. Upon Premarket Approval we will expediently engage new studies to further illustrate our technology’s capability in treating a wide-array of other conditions with our biologically potent, off-the-shelf, allogeneic treatment where currently human leukocyte antigen (HLA) markers prevent a recipient from obtaining a matching transplant (graft).
About Graft-Versus-Host Disease (GVHD)
GVHD is a rare complication following allogeneic tissue transplants, including bone marrow and cord blood transplants, wherein immune cells in the transplanted tissue (the graft) recognize the recipient (the host) as “foreign” and begin to attack the host’s cells. Acute GVHD can result in significant damage to the liver, skin, mucosa and the gastrointestinal tract and is a major issue associated with high morbidity and mortality in transplants.
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is an innovative biotechnology company developing bioelectronic devices and therapies for regenerative medicine. Endonovo’s Immunotronics™ platform is a non-invasive, non-implantable bioelectronic device for treating/preventing vital organ failure through the reduction of inflammation, cell death and the promotion of regeneration. Endonovo’s Cytotronics™ platform provides for a method of expanding and enhancing the biological and therapeutic properties of cells for the development of next-generation cell therapies. The Company’s initial concentration is on the treatment of acute and chronic inflammatory conditions of the liver using its proprietary Immunotronics™ platform and the treatment of Graft-Versus-Host Disease using its ex vivo expanded and enhanced stem cells.
Safe Harbor Statement
This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, trends, analysis, and other information contained in this press release including words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” and other similar expressions of opinion, constitute forward-looking statements. Any such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any future results described within the forward-looking statements. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company’s reports filed with the Securities and Exchange Commission. The forward-looking information provided herein represents the Company’s estimates as of the date of the press release, and subsequent events and developments may cause the Company’s estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company’s estimates of its future financial performance as of any date subsequent to the date of this press release.