Bioggio, Switzerland, 7th January 2013 - Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, today announced that it has received FDA authorisation (IND: permission to use an investigational new drug in humans) for a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in CIS (carcinoma in situ) in the bladder.
Patients with CIS have a much more aggressive cancer where progress is faster than for papillary tumours. However, there have been no recently approved treatments offering any benefit for CIS. There is therefore a high medical need for better and more innovative interventions such as TMX-101. The planned Phase II study is due to commence in March 2013 and will involve a small number of CIS patients recruited from private urology clinics in the USA to examine at the efficacy of TMX-101 over six doses.
Dr Johanna Holldack, CEO of Telormedix, commented:
“Our recently completed safety trial of TMX-101 also showed it induced a strong disease-modifying cytokine response in patients with non-muscle invasive bladder cancer (NMIBC). We have high hopes that this means TMX-101 will demonstrate disease modifying efficacy in CIS.“
Dr Stuart Holden, a prominent practicing uro-oncologist and Telormedix board member, added:
“We have known for many years that CIS patients respond well to immunotherapeutic interventions such as BCG. So there are already good reasons to be optimistic that TLR-7 mediated treatments such as TMX-101 will offer a new and effective clinical tool in the treatment of this aggressive carcinoma.”
Johanna Holldack, Telormedix’s Chief Executive Officer, will be presenting at the Biotech Showcase 2013 in San Francisco, CA. on Wednesday 9th January on the status of the Company’s drug pipeline as well as this trial 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, will shortly commence 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’s 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 favorable 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.