Debiopharm successfully completes randomized Phase II study for IAP antagonist Debio 1143 in high risk head & neck cancer patients

Lausanne, Switzerland (ots) - Debiopharm (www.debiopharm.com), a
Swiss biopharmaceutical company, announced positive topline results
across clinical endpoints following the completion of the two-year
follow-up period of its double-blind, randomized Phase II study of
Debio 1143 in high-risk, previously untreated patients with locally
advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
These significant results, including the primary endpoint LRC
(locoregional control) being met along with prolonged PFS
(progression-free survival), will be presented at the forthcoming
European Society for Medical Oncology (ESMO) congress in Barcelona in
September 2019 by the lead investigator, Professor Jean Bourhis, Head
of the Radio-Oncology department at the University Hospital of
Lausanne, Switzerland.

This robust Phase II trial, which included 96 patients, was
designed to demonstrate the efficacy and safety of this IAP
antagonist, first in its class to be Phase III ready. The results
support future clinical assessments of the compound in stage III-IV
LA-SCCHN patients as a frontline treatment in combination with CRT.

"We initiated the Debio 1143 clinical development program to
address the high unmet medical need in LA-SCCHN patients who have a
poor prognosis, including those who are HPV-negative and heavy
smokers. This new data strongly suggests that our product may enhance
efficacy of the current standard of care for patients suffering from
this particularly debilitating type of tumor." - Angela Zubel, Chief
Development Officer, Debiopharm.

In parallel with the design and initiation of a registration Phase
III study, Debiopharm is actively considering potential partnerships
with pharmaceutical industry leaders in order to deliver a new
therapeutic option to LA-SCCHN patients as soon as possible.

Head and neck cancer is the 6th most common cancer worldwide, with
a complex management strategy including the standard administration
of CRT along with surgery when possible. The two main pathological
causes for SCCHN are tobacco/alcohol consumption and human
papillomavirus (HPV) infection. Although the standard of care
improves survival and quality of life for many patients, more than
half of high-risk patients, notably heavy smokers (>10 pack-years)
and those with HPV-negative tumors, will relapse.

About Debio 1143

Debio 1143 is an antagonist of IAPs (inhibitor of apoptosis
proteins), acting as chemo-radio-sensitizer to enhance treatment
efficacy with a dual mode of action, promoting programmed cell death
and fostering anti-tumor immunity. Currently in clinical development
in a broad range of cancer types, the compound is being developed in
combination with chemo-radiotherapy or with ICIs (PD-1/PD-L1), with
reported data consistently showing a favorable safety profile. Over
200 patients have been treated so far with Debio 1143 in various
indications and lines of treatment.

Trial information:

- Head & neck cancers:
https://patients.debiopharm.com/head-and-neck-cancer/
- Small cell lung cancers:
https://patients.debiopharm.com/small-cell-lung-cancer-sclc/
- Gastrointestinal cancers:
https://patients.debiopharm.com/gastrointestinal-cancers/
- Gynecologic cancers:
https://patients.debiopharm.com/gynecologic-cancer/

Debiopharm's commitment to cancer patients

Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology. Bridging the gap between disruptive
discovery products and real-world patient reach, we identify
high-potential compounds for in-licensing, clinically demonstrate
their safety and efficacy and then select large pharmaceutical
commercialization partners to maximize patient access globally.

Visit us www.debiopharm.com/

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Pressekontakt:
Dawn Haughton - Communication Manager
dawn.haughton@debiopharm.com
Tel: +41 (0)21 321 01 11

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell