Spotlight Innovation Subsidiary Celtic Biotech Iowa Receives Approval to Commence Phase I Part 2 Clinical Trial of Crotoxin
The French National Agency for the Safety of Medicines and Health Products Has Approved Additional Testing of Cancer Drug Candidate
WEST DES MOINES, Iowa, Nov. 10, 2016 /PRNewswire/ -- Spotlight Innovation Inc. (OTCQB: STLT) announced today that its subsidiary Celtic Biotech Iowa has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) to commence Part 2 of its Phase I dose escalation safety study, Crotoxin in Patients with Advanced Cancer using an Intravenous Route of Administration. The ANSM, a healthcare regulatory agency, acts on behalf of the French government to ensure patient safety. The clinical study will be conducted at Pitié-Salpêtrière Hospital in Paris. Noted French oncologist David Khayat, MD, PhD, FASCO, is the Principal Investigator.
Part 2 of the Phase I trial will build upon the dose escalation procedures employed in Part 1. The success of Part 1 allowed for the extensive revision of the Part 2 protocol, which seeks to determine whether faster dose escalation can be attained in a shortened timeframe without increased risk to patients.
Mr. Cristopher Grunewald, Spotlight Innovation's President and Chief Executive Officer, said, "We invested significant time and effort to advance our treatment paradigm using the results of Part 1. We are very pleased that our Part 2 protocol was accepted and approved by ANSM. This marks a significant milestone for Crotoxin as it enters the next stage of clinical testing."
About Spotlight Innovation Inc.
Spotlight Innovation Inc. (OTCQB: STLT) identifies and acquires rights to innovative, proprietary technologies designed to address unmet medical needs, with an emphasis on rare, emerging and neglected diseases. To find and evaluate unique opportunities, we leverage our extensive relationships with leading scientists, academic institutions and other sources. We provide value-added development capability to accelerate development progress. When scientifically significant benchmarks have been achieved, we will endeavor to partner with proven market leaders via sale, out-license or strategic alliance. For more information, visit www.spotlightinnovation.com or follow us on www.twitter.com/spotlightinno.
Forward Looking Statements
Statements in this press release that are not purely historical are forward-looking statements. Forward-looking statements herein include statements regarding Spotlight Innovation's efforts to develop and commercialize its various technologies, and to achieve its stated benchmarks. Actual outcomes and actual results could differ materially from those in such forward-looking statements. Factors that could cause actual results to differ materially include: risks and uncertainties, such as the inability to finance the planned development of the technologies; the inability to hire appropriate staff to develop the technologies; unforeseen technical difficulties in developing the technologies; the inability to obtain regulatory approval for human use; competitors' therapies proving to be more effective, cheaper or otherwise more preferable; or, the inability to market a product. All of which could, among other things, delay or prevent product release, as well as other factors expressed from time to time in Spotlight Innovation's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Spotlight Innovation's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release and Spotlight Innovation undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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SOURCE Spotlight Innovation Inc.
Released November 10, 2016