Bioggio, Switzerland, 11 March 2013 - Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, today announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
The planned Phase II study with TMX-101 will involve a small number of CIS patients recruited from private urology clinics in the USA to examine the efficacy of the drug over six doses. Full details of the trial design are available at www.clinicaltrials.gov ID: NCT01731652.
Patients with high-grade tumors or CIS currently most often receive treatment with Bacillus Calmette-Guérin (BCG), an intravesical immunotherapy that is unfortunately often accompanied by prolonged bladder irritation, fever, and bleeding which may force the doctor to decrease the BCG dosage or to discontinue the therapy.
Dr Johanna Holldack, CEO of Telormedix, commented:
“It is great to be starting 2013 with significant progress in advancing our product TMX-101 in the clinic, as we believe that it will offer several advantages over the current standard treatment with BCG. Our specialist oncology CRO, Medelis, is also doing superb work on this trial and has been supporting us through the whole IND set up process.”
Neal D. Shore, M.D., the Medical Director of the Carolina Urologic Research Center and principal investigator in this trial, added:
“TMX-101 has already demonstrated a strong disease-modifying cytokine response in a clinical trial involving patients with non-muscle invasive bladder cancer (NMIBC). CIS is obviously a more aggressive cancer, but we do know that it responds well to immunotherapeutic interventions. We are therefore extremely hopeful that targeting TLR-7 with TMX-101 will prove to be a successful and efficacious treatment option in these patients.”
Johanna Holldack, Telormedix’s Chief Executive Officer, will be attending BIOEurope Spring in Barcelona, Spain on March 11th and 12th and will be available to speak to media and any other interested parties attending the conference.
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 autoimmune diseases. The Company’s lead product, TMX-101, is currently in a Phase II clinical trial for the treatment of CIS (carcinoma in situ) in the bladder. In addition, Telormedix is developing novel TLR7-targeted agonists. One of these molecules, TMX-202, has recently been selected for preclinical study for the topical treatment of skin cancers and other indications. Telormedix also has a pipeline of programs for inflammatory and autoimmune diseases, which includes TMX-302, a TLR7-binding small molecule showing anti-inflammatory properties in vivo.
Located in Switzerland, Telormedix is led by a highly experienced management team and backed by an international consortium of venture capitalists including Aravis Venture (Basel, Switzerland) and Proquest Investments (Princeton-San Diego, USA).
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Telormedix’ lead product, TMX-101, is a targeted small molecule for the treatment of superficial bladder cancer. The active ingredient in TMX-101 is a known immunomodulatory molecule with a favourable safety profile and a demonstrated clinical efficacy in oncological and viral diseases. The Company expects that this targeted therapy will have an improved safety and efficacy profile in comparison to standard of care. Telormedix has taken advantage of existing regulatory data and clinical experience in order to bring TMX-101 quickly through Phase I/II clinical trials.