Sirona Biochem CEO's Report On Progress
Published: Sep 21, 2017
VANCOUVER, BC--(Marketwired - September 21, 2017) - Sirona Biochem Corp. (TSX VENTURE: SBM) (
I would like to thank you for your continued support while we work through the negotiations for our skin lightener. The following is an update on our progress to date.
Skin Lightener, TFC-1067
We are pleased to announce that we have exchanged term sheets and advanced negotiations are ongoing with potential global partners. We will update our shareholders immediately upon any material change in the status of negotiations.
SGLT2 Inhibitor, SBM-TFC-039 (Wanbang)
Wanbang Biopharmaceuticals provided a progress report on the IND (Investigational New Drug) package that will go to the China Food and Drug Administration (CFDA). In vivo studies show that the SGLT2 Inhibitor significantly lowered blood glucose levels.
Further in vivo and in vitro studies, including toxicology, are wrapping up now and results are expected by November. CMC (chemistry, manufacturing and control) studies on pharmaceutical grade batch preparations are complete and have met reference standards for use in clinical studies.
Wanbang expects to file the IND to the CFDA by the end of this year. This will trigger another milestone payment of $500,000 USD to Sirona.
Recently, the Indian subsidiary of a global pharmaceutical company has expressed interest in licensing SBM-TFC-039 for India and have begun due diligence.
Cell Preservation and Anti-Aging (Glycoprotein) Library
In December 2016, we concluded testing of our glycoprotein compound library. Studies were successful in showing efficacy against various stressors in skin cells. There are many potential commercial applications of these compounds and interested partners requested a better understanding of the mechanism of action. We decided to go back to testing and do a full genomic study. These results will show us the pathways being affected within the cells and enable us to develop a more complete package of information for prospective companies. We are currently waiting for the report and anticipate receiving it early October 2017.
Several of the compounds have completed chemistry and we will begin preclinical testing in Q4 2017. This was moved out slightly from mid-2017 due to chemistry process optimization.
We are working to put in place a Contract Research Organization (CRO) based in Europe with expertise in Keloid research to assist us. This has been delayed due to resource allocation.
Skin Lightener, TFC-849 (Valeant)
Our skin lightener asset, TFC-849, will be transferred with the sale of Obagi to Haitong International Zhonghua Finance Acquisition Fund I LP. The transaction is expected to be completed this year and we are continuing to work with Valeant during the transition. Limited partners of the fund include China Regenerative Medicine International Ltd. CRMI is a public company, traded on the Hong Kong stock exchange and currently focuses on three major business segments: tissue engineering, cell therapy, and cosmetics. With a China based company, they are well positioned to enter the skin lightening market.
Again, we thank you for your continued support and patience during this time.
Dr. Howard Verrico, CEO
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.