Threshold Pharmaceuticals, Inc.
) recently announced the commencement of a global phase III study
(MAESTRO) on their hypoxia-targeted candidate, TH-302. The study
will evaluate the efficacy and safety of TH-302 plus
Eli Lilly and Company
) Gemzar (gemcitabine) in patients with previously untreated,
locally advanced unresectable or metastatic pancreatic
We note that the study is being conducted under the US Food
and Drug Administration's (FDA) Special Protocol Assessment (SPA)
program. The randomized, double-blind, placebo controlled,
international and multi-center study will enroll roughly 660
patients and will compare TH-302 plus Gemzar with placebo plus
Gemzar. The study's primary endpoint is overall survival and the
secondary endpoints include efficacy measured by progression-free
survival (PFS), overall response rate and disease control
On Feb 21, 2012, Merck KGaA had presented encouraging phase
IIb data on the TH-302 - Gemzar combination for the first-line
treatment of patients suffering from advanced pancreatic cancer.
The study met its primary endpoint by achieving a 63% improvement
in PFS in patients treated with TH-302 and Gemzar in comparison
to Gemzar alone.
Another phase III trial is being conducted with Merck's TH-302
under the FDA's SPA program. The study will compare TH-302 in
combination with doxorubicin to doxorubicin alone for treating
patients with soft tissue sarcoma (STS). Merck KGaA has orphan
drug status in the US as well as the EU for TH-302 for the STS
According to information provided by Merck KGaA, pancreatic
cancer accounts for 2.2% of all cancers reflecting roughly
277,000 cases every year. It is the eighth most common type of
cancer in Europe and the eleventh most prevalent in the US.
We believe the approval of TH-302 will boost Merck KGaA's
oncology sales significantly. Erbitux is one of the marketed
cancer treatments in Merck KGaA's product portfolio. Erbitux is
indicated for metastatic colorectal cancer (mCRC) and squamous
cell carcinoma of the head and neck (SCCHN). Erbitux' revenues
for the nine months ending Sep 30, 2012 were $664 million. Other
cancer candidates in Merck KGaA's pipeline include cilengitide
Meanwhile, the successful development of TH-302 will be a
major milestone for Threshold Pharma, which currently does not
have any marketed products in its portfolio. Threshold Pharma
carries a Zacks Rank #3 (Hold). Right now,
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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