Sorrento Announced FDA Authorization Of IND To Commence Clinical Trial Of RTX In Intractable Cancer Pain
June 29, 2017
By Mark Terry, BioSpace.com Breaking News Staff
TiGenix NV (TIG), headquartered in Leuven, Belgium, announced that it is opening an office in Cambridge, Mass.
The company focuses on the anti-inflammatory aspects of donor-derived stem cells to develop new drugs. Its lead product is Cx601 to treat complex perianal fistulas in Crohn’s disease patients.
The company’s U.S. operations will be based at the Cambridge Innovation Center in Kendall Square. It is still in the process of appointing a senior support team for the U.S. and Canadian launch of its worldwide Phase III clinical trial for Cx601. The trial started in Europe and Israel in June 2017.
“It is very exciting to be establishing TiGenix at the heart of one of the world’s leading biotechnology hubs,” said Eduardo BravoTiGenix’ chief executive officer, in a statement. “We are working hard to progress the development of Cx601 in the U.S. and having a team based in Cambridge will add further momentum to these efforts to bring a new treatment option to U.S. patients suffering from this severe and debilitating complication of Crohn’s disease.”
TiGenix launched an initial public offering (IPO) in December 2016, and has rocketed by 40 percent since. And the company inked a licensing deal with Japanese company Takeda over rights to Cx601 outside the U.S. for $400 million-plus. TiGenix kept all U.S. rights.
Logribel Biostocks, writing for Seeking Alpha, says, “If approved, Cx601 would be the first major medical innovation for over a decade in the treatment of what is an extremely debilitating side-effect of Crohn’s disease. Today, patients suffering from refractory, complex perianal fistulas are typically treated with antiTNFalpha drugs (Remicade being the only approved treatment after patients have failed conventional drugs) and an estimated 80 percent of those patients end up being refractory to the drug at one point, leaving them with surgery as a last resort—a painful procedure with high risks of relapse and anal incontinence.”
Christophe Weber, the chief executive officer of Takeda, during the company’s first-quarter 2017 earnings call, discussed Cx601, saying, “It’s a very innovative way of intervening, the number of patients is much—is very limited, but the medical need is very, very significant because there is very little alternative except surgery. So I think for the moment, we are very much working on preparing the launch, working out the supply chain because it’s a new field with stem cell therapy. That’s also what is very attractive in our mind is that this is potentially helping us to learn how to manage this type of product which will—there will be more and more of this product in the future. So I think that’s very exciting. And we’ll continue to see whether we want to expand the partnership beyond Europe.”
Logribel Biostocks projects potential peak worldwide sales of Cx601 to range from $475 million to almost $1 billion.
Logribel Biostocks cites several potential catalysts for TiGenix, with the earliest being the European approval of Cx601 by the end of this year, with news of potential RMAT designation in early 2018 or an Orphan Drug Designation in the third quarter of this year.
RMAT is a new designation that came out of the 21st Century Cures Act, signed into law on December 13, 2016. It stands for Regenerative Medicine Advanced Therapy Designation. Companies of certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combo products, may obtain the
SAN DIEGO, June 29, 2017 /PRNewswire/ -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug Application (IND) for Resiniferatoxin (RTX), a non-opioid, TRPV1 agonist that selectively targets afferent nerve activation involved in chronic pain states. Sorrento intends to promptly initiate a multicenter, Phase 1b clinical trial of RTX administered by epidural injection for the treatment of intractable pain associated with cancer. RTX has been granted FDA Orphan Drug Status for pain associated with end stage disease.
"Given its unique mechanism of action, we view RTX as a franchise molecule, uniquely positioned to halt the neurogenic inflammation cycle in a number of clinical indications. Our intention is to commence our clinical path in cancer since more than 80% of cancer patients experience uncontrolled pain during their disease and 20% of these patients remain unresponsive or intolerant to mainstay, opioid therapyi. We are confident in RTX providing meaningful relief to these patients given previous pre-clinical and clinical findings demonstrating that a single injection of RTX could safely and effectively reduce severe pain as well as the use of concomitant analgesics," said Dr. Henry Ji, President and Chief Executive Officer of Sorrento Therapeutics, Inc.
RTX has been extensively tested in animals and is currently the subject of a Phase I clinical trial at the National Institute of Health (NIH) under a Cooperative Research and Development Agreement (CRADA). To date, 12 patients with terminal cancer pain have been treated. When injected intrathecally, RTX has been shown to directly interact with nerve cells expressing TRPV1 receptors without affecting normal sensation (touch and vibration sense) or muscle function. Preliminary results from the NIH trial demonstrate that a single injection of RTX was well tolerated at the dose levels tested and provided clinically meaningful reductions in pain and a reduced dependence on opioids. In contrast to opioids, RTX treatment did not result in systemic adverse events such as cognitive impairment, sedation or respiratory depression, and enabled patients to increase their activity levels.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for immuno-oncology, inflammation and autoimmune diseases. Sorrento's lead product candidates include immunotherapies focused on the treatment of both solid tumors and hematological malignancies, as well as late stage pain products.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the outcome of the data from a clinical trial for RTX, and Scintilla's prospects, Sorrento's M&A strategy and Sorrento's ability to accelerate the development of its lead programs, particularly in oncology, in the clinic. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to that RTX may not meet all endpoints of the clinical study, that the data may not support an NDA submission and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2016, as amended. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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i Currow DC et al. Defining refractory pain in cancer for clinicians and researchers. J Palliat Med 2012; 15(1):5-6.
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