Diatos S.A. Announces Successful Completion of Phase I Trial for DTS-201
Published: Oct 22, 2007
DTS-201 is a novel doxorubicin prodrug developed for the targeted treatment of several solid cancers, including chemo-resistant tumors. DTS-201 uses the Tumor Selective Prodrug (TSP) technology which causes the product to be activated by enzymes specifically expressed by the tumor whilst ignoring healthy cells.
The purpose of the DTS-201 clinical Phase I study was to assess the product’s Maximum Tolerated Dose (MTD), safety profile and pharmacokinetic profile in patients with advanced or metastatic solid tumors. Results from this trial will be presented at the AACR conference in a poster entitled “Results of a first in man phase I study assessing the safety and pharmacokinetics of a one hour intravenous infusion of DTS-201 every 3 weeks in patients with advanced or metastatic solid tumors. (abstract # 776)”.
From the trial, researchers concluded that:
§ DTS-201 was well tolerated by twenty-five cancer patients treated with doses of up to 400 mg/m2 every three weeks
§ Evidence of clinical efficacy was observed: More than 40% of patients had clinical benefit, nine patients with chemo-resistant tumors showed disease stabilisation for at least 4 treatment cycles and one patient showed partial response
§ DTS-201 was safe and well tolerated at cumulative doses of up to 2400 mg/m2 (Doxorubicin equivalent dose is approximately 1300 mg/m2)
§ The main dose limiting toxicity is reversable neutropenia (hematological) of short duration
§ Non-hematological toxicity adverse events were mild to moderate and no drug related cardiac toxicity was observed
§ Clinical data provide first proof of concept in man for the Tumor Selective Prodrug (TSP) technology
§ The recommended dose for clinical Phase II trials is 400 mg/m2
The high level of safety and evidence of clinical efficacy observed during this clinical Phase I trial warrants further assessment of the product in multiple clinical Phase II studies.
President and CEO of Diatos John Tchelingerian, Ph.D, remarked: “This clinical Phase I study with DTS-201 provides us with initial human proof of concept of our Tumor Selective Prodrug technology. The expected initiation of multiple clinical Phase II studies for DTS-201 in the near future demonstrates the potential of our DTS-201 product and the Tumor Selective Prodrug platform technology.”