Bioggio, Switzerland, 16 May 2014 - Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, today announced that it has successfully completed a Phase II trial, conducted under an IND, of Vesimune (TMX-101) in CIS (carcinoma in situ) of the bladder.
The open-label Phase II clinical trial involved 12 CIS patients recruited from sites in the USA to examine the efficacy of Vesimune over six doses. The study population involved both BCG (Bacillus Calmette-Guérin) pre-treated and naïve patients and each patient received 6 weekly instillations of Vesimune into the bladder. Ten of the 12 patients were evaluable with 4 showing a response. 3 out of the 4 were complete responders and therefore reached the clinical endpoint of complete remission after only one cycle of therapy. Only mild and moderate side effects were found mostly related directly to the bladder (burning, urge to void) and comparable to other commonly used intravesical agents.
Neal Shore, MD, Medical Director, Carolina Urologic Research Center, Myrtle Beach, South Carolina and one of the Principal Investigators on this trial commented: “Bladder cancer is a disease with significant unmet therapeutic needs, with a paucity of new drug therapies for over three decades. Currently, BCG and valrubicin are the only FDA approved intravesical options for bladder cancer, and if these options fail, then surgical removal of the bladder is considered. Vesimune intravesical therapy is a promising option with an alternative and promising pathway of therapeutic activity.”
Johanna Holldack, CEO of Telormedix, added: “With this successful Phase II completed, we are now eager to speak to potential license partners we can work with to progress Vesimune to market.”
The active ingredient in Vesimune is a known immuno-modulatory molecule with a favourable safety profile and a demonstrated clinical efficacy in oncological and viral diseases. Telormedix expects that this targeted therapy will have an improved safety and efficacy profile in comparison to standard of care.
Telormedix will be conducting an investigator meeting on 17 May while also attending the American Urological Association (AUA) conference on 16-21 May in Orlando, Florida.
Telormedix (www.telormedix.com), founded in October 2007, is a biopharmaceutical company focused on targeted immunity and modulation of the innate immune system for treating cancer and inflammatory diseases. The Company’s lead product, Vesimune (TMX-101), has just successfully completed a Phase II clinical trial for the treatment of CIS (carcinoma in situ) of the bladder. In addition, Telormedix is developing two additional TLR7-targeted molecules, TMX-201 and TMX-202 both of which would make good vaccine adjuvants. As these molecules have substantially improved pharmacokinetics and pharmacodynamics profiles they have the potential to fully realise the anticancer promise of TLR 7 agonists. One of these molecules, TMX-202 has recently been selected for preclinical study for the topical treatment of skin cancers and other indications. The candidate has already successfully completed a number of in vivo studies.
For more information please contact:
+41 (0)91 610 7000
Media Enquiries – Instinctif Partners:
Robert Mayer / Cora Kaiser
+49 (0)89 3090 5189 13 / 11