DGAP-News: Xenikos B.V. / Key word(s): Conference
Xenikos announces data from phase I/II trial with T-GuardTM for the treatment of
The presentation, titled, "A Phase I/II Study on the Anti-CD3/CD7 Immunotoxin Combination (T-GuardTM) for the Treatment of Steroid-Refractory Acute GVHD," will be given by Walter J. F. M. van der Velden, MD, PhD.
T-Guard is a combination of two toxin-loaded anti-T-cell antibodies being developed as a tool to safely and swiftly rebalance the body's immune system in T-cell mediated diseases, such as GVHD. The data being presented at the conference demonstrate strong clinical response rates in combination with a high overall survival rate compared to a case series of historical controls.
"We are excited about the opportunity to present data from this important clinical study providing further evidence for the potential of our lead candidate T-Guardat this highly regarded conference," said Ypke van Oosterhout, PhD, Chief Executive Officer of Xenikos. "We are looking forward to discussing the results with regulatory and medical experts to gain valuable input on the future development of T-Guard, which is important as we prepare to start a pivotal phase III trial shortly, aiming to bring this product to patients as soon as possible."
The abstract can be accessed online at
Xenikos recently completed a phase I/II study in 20 patients with severe steroid refractory acute GVHD, who received the one-week treatment course with T-Guard as second line treatment. Based on the results, the Company believes that T-Guard has the potential to offer a curative approach using a single-week treatment for patients with steroid-refractory acute GVHD. Mainly because, unlike other concepts that only improve the symptomatic treatment, T-Guard actively restores the immunological balance, providing a durable remedy for patients with this devastating and potentially lethal disease.
Following the promising outcome of the phase I/II study the Company plans to initiate a pivotal clinical phase III study in 2018. Other areas of future development may include transplant-related rejection, acute solid-organ rejection and several severe autoimmune diseases.
Xenikos B.V. is developing new, innovative immunotherapies to help restore patients' health and save lives. It is developing new therapies based on the action of conjugated antibodies that enables patients suffering from serious immune diseases or rejection after transplantation to reset their immune systems quickly and efficiently. Its lead product candidate T-Guard(TM) is currently being developed for the second-line treatment of steroid-resistant acute GVHD. Further information is available at www.xenikos.com.
02.11.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.