Date: 2014-05-16
Type of information: Completion of the trial
phase: 2
Announcement: completion of the trial
Company: Telormedix (Switzerland)
Product: Vesimune (TMX-101)
Action
mechanism: TMX-101 is TLR-7 agonist 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.
Disease: CIS (carcinoma in situ) in the bladder
Therapeutic area: Cancer- Oncology
Country: USA
Trial
details: This Phase II pilot study will explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment (NCT01731652).
Latest
news: * On May 16, 2014,Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, 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 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. Telormedix will now look for potential license partners to work with to progress Vesimune to market. * On March 11, 2013, Telormedix has 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. 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. * On January 7, 2013, Telormedix has announced that it has received FDA authorisation 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.
