Telesta Therapeutics
Formerly called | Bioniche Life Sciences Inc. |
|---|---|
| Public | |
| Traded as | TSX: TST (formerly TSX: BNC) |
| Industry | pharmaceutical |
Key people | Michael Berendt (CEO, CSO) |
Telesta Therapeutics Inc. is a publicly traded, Canadian pharmaceutical company based in Montreal, Quebec.[1] CEO Michael Berendt; prior to joining Telesta, was the president and CEO of Aegera Therapeutics.[2]
As part of the strategic push to focus on late stage human therapeutics, effective May 2014, the company divested its Animal Health unit to Vétoquinol, a family-owned, global animal health company led by CEO Matthieu Frechin.[3]
In 2014, a court decision involving a group of Bioniche shareholders and the Bioniche board of directors established a precedent in the Canadian court system for conditions under which a board may choose not to select the date proposed by shareholders for an Annual Meeting, but rather schedule on a date of the board's choosing, thus confirming "that directors have wide latitude to manage corporate affairs."[4]
Telesta is listed on the Toronto Stock Exchange under the symbol TST.[1] Prior to the name change for the company, trading was done under the symbol BNC.[5]
As of December 2014, the strategic focus of Telesta was on the commercialization of "Mycobacterium phlei cell-wall - nucleic acid complex" (MCNA) for the treatment of bladder cancer.[6] The company pursued but did not secure orphan drug status via the United States Food and Drug Administration.[7]
Telesta's Biologic license application for the drug MCNA (Mycobacterium phlei Cell Wall-Nucleic Acid Complex), formerly "Urocidin", is currently under the FDA Fast Track Development Program. MCNA could come available for patients in February 2016.[8]
MCNA's safety profile is superior to the other available treatments after BCG-failure (1.5% Adverse event for MNCA compared to >30% AEs for Valrubicin (Valstar)). The drug MCNA had a 100% - 250% higher efficacy in the pivotal clinical trial than Valstar (<10% DFS for Valstar, 25% DFS for MCNA) and MCNA had a 35% DFS after a one year treatment on papillary-only patients with NMIBC, which is 90% of all NMIBC cases.[9]
With MCNA there is also the unique possibility for urologists to administer the drug immediately following TURBT, as opposed to weeks after with either BCG or Mitomycyn C. This means MCNA could kill free floating cancer cells and not give them the opportunity adhere to the bladder walls, after tumors have been removed.
References
- 1 2 "Company Information". Stock Market Quotes. TMX Group.
- ↑ Slatko, Joshua (December 2013). "BMS changes senior management team". People on the Move: Pharma. Med Ad News. p. 27.
- ↑ Staff (1 April 2014). "Vétoquinol Acquires Animal Health Business of Bioniche Life Sciences". DVM Newsmagazine. Advanstar – via Highbeam Research.
- ↑ White, Guy (26 April 2014). "Proactive Business Judgment in Proxy Contests". Mondaq Business Briefing. Mondaq – via Highbeam Research.
- ↑ "Bioniche". Telesta. Retrieved 24 January 2015.
The Company is publicly traded on the Toronto Stock Exchange and, effective on Monday, December 1st, its ticker will change to TSX:TST from TSX.BNC.
- ↑ Staff (14 December 2014). "Bioniche Life Sciences Inc. Rebrands as Telesta Therapeutics Inc". Health & Medicine Week. NewsRx – via Highbeam Research.
- ↑ Staff (19 November 2014). "Orphan Drug Designation Update and Annual General Meeting Reminder". Biotech Week – via Highbeam Research.
- ↑ "Telesta Receives FDA BLA Filing Notification Letter and Priority Review Designation for MCNA1" (PDF). Aug 2015.
- ↑ "Bioniche Life Sciences Inc. to Publish Comprehensive Phase 3 Clinical Trial Results In The Journal of Urology" (PDF). Oct 2014.