DGAP-News

RedHill Biopharma Ltd.: RedHill Biopharma Announces Phase Ib/II Study with YELIVA(TM) Initiated for Multiple Myeloma at a Leading U.S. Academic Medical Center - Seite 3

The primary objectives of the second portion of the study (Phase II) are to
assess the overall treatment response rate and overall survival. Secondary
objectives include evaluating the treatment response to YELIVA(TM) in
patients with refractory or relapsed multiple myeloma after three cycles of
treatment and evaluation of pharmacodynamic markers. The Phase II portion
will be conducted at multiple sites and will be managed by the Duke Cancer
Network.

Results from the Phase I study with YELIVA(TM) in patients with advanced
solid tumors confirmed that the study, conducted at the Medical University
of South Carolina (MUSC), successfully met its primary and secondary
endpoints, demonstrating that the drug is well-tolerated and can be safely
administered to cancer patients at doses that provide circulating drug
levels that are predicted to have therapeutic activity.

Among the 16 subjects that were assessable for response by RECIST 1.1
criteria (Response Evaluation Criteria in Solid Tumors), one subject had a
partial response with a progression-free survival of 16.9 months, and six
subjects had stable disease with a progression-free survival of between 3.5
and 17.6 months. Of the three patients with cholangiocarcinoma, one had a
partial response and the other two had stable disease, one for over a year.
YELIVA(TM) was well tolerated over a prolonged period at doses inducing the
expected pharmacodynamic effects.

A Phase II study with YELIVA(TM) for the treatment of advanced
hepatocellular carcinoma is planned to be initiated in the coming weeks.
The study will be conducted at MUSC Hollings Cancer Center and additional
clinical centers in the U.S. It is supported by a $1.8 million grant from
the NCI awarded to MUSC, intended to fund a broad range of studies on the
feasibility of targeting sphingolipid metabolism for the treatment of a
variety of solid tumor cancers, including the Phase II study with
YELIVA(TM), and will be further supported by additional funding from
RedHill.

A clinical study to evaluate YELIVA(TM) as a radioprotectant for prevention
of mucositis in head and neck cancer patients undergoing therapeutic
radiotherapy is also planned.

A Phase I/II clinical study evaluating YELIVA(TM) in patients with
refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at
the Louisiana State University Health Sciences Center (LSUHSC) in New
Orleans in June 2015 and is expected to resume later this year following
administrative hold and pending a protocol amendment aimed at improving
overall recruitment. The study is supported by a grant awarded to Apogee