Threshold Pharmaceuticals, Inc. (THLD) recently initiated a phase II trial on its pipeline candidate, TH-302.
The trial is being conducted to evaluate the efficacy and safety of TH-302 in patients suffering from melanoma.
The primary endpoint of the phase II trial is three-month progression-free survival while key secondary endpoints include response rate, duration of response, and overall survival.
Threshold Pharma is developing TH-302 in collaboration with Merck KGaA (MKGAY), which will fund 70% of the development costs. The agreement provides Threshold Pharma an option to co-commercialize TH-302 in the U.S.
As per The American Cancer Society, around 76,690 new patients will be affected by melanoma in the U.S. in 2013, resulting in 9,480 deaths this year.
We note that TH-302 is being developed for other indications as well with two ongoing phase III trials.
TH-302 is being evaluated in combination with Doxil versus only Doxil in patients with soft tissue sarcoma (STS).
TH-302 is in another phase III study that is evaluating the efficacy and safety of TH-302 plus Eli Lilly and Company’s (LLY) Gemzar in patients with advanced pancreatic cancer.
We remind investors that the TH-302 enjoys orphan drug status in the U.S. and EU for the treatment of STS.
The successful development of TH-302 will be a major milestone for Threshold Pharma, which currently does not have any marketed product in its portfolio.
Threshold Pharma currently carries a Zacks Rank #4 (Sell). Right now, Biogen Idec Inc. (BIIB) looks more attractive with a Zacks Rank #1 (Strong Buy).
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