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22 Biopharma Stocks With Breakout Potential in 2012

Exact Sciences (EXAS)
Diagnostic/indication: Cologuard to detect colon cancer and pre-cancerous polyps in the colon. (phase III trial)
Top-line results expected in the fourth quarter.
Cologuard is a non-invasive test designed to measure genetic abnormalities in stool that detects early-stage colon cancer and pre-cancerous polyps. Currently available colon cancer screening test can't reliably detect cancer at early stages, which means patients at risk must undergo expensive and invasive colonoscopies. Cologuard won't replace colonoscopies but could cut down on the number of the invasive tests performed.
The phase III "Deep-C" study is designed to prospectively validate the sensitivity and specificity of Cologuard compared to colonoscopy. If positive, Exact Sciences will seek FDA approval in the first quarter of next year.

Geron (GERN - Get Report)
Drug/indication: Imetelstat in non-small cell lung cancer (phase II trial)
Top-line results expected in the fourth quarter

Geron (GERN - Get Report) took a beating late last year when it gave up on its embryonic stem cell therapy. Now, the company is focusing its drug development activities on its cancer therapeutics, many of which pre-date its stem-cell research. Geron will help its turnaround efforts a great deal if it can manage to produce a win from a phase II lung cancer study of imetelstat.
The study compares imetelstat to standard of care as maintenance therapy in non-small cell lung cancer patients who responded to previous chemotherapy. The primary endpoint is improvement in progression-free survival.

Lexicon Pharmaceuticals (LXRX)
Drug/indication: LX4211 in Type 2 diabetes (phase II trial)
Top line results expected by the end of the second quarter
The phase II study compares LX4211 plus metformin to metformin alone in type 2 diabetes patients with inadequate blood sugar control. The study's primary endpoint will measure the change in HbA1c, or blood glucose levels from baseline to week 12.

Nektar Therapeutics (NKTR)
Drug/indication: NKTR-118 for opioid-induced constipation (phase III trials)
Top-line results expected in the fourth quarter
Nektar's partner Astrazeneca (AZN) is conducting the "KODIAC" trials, consisting of two phase III placebo-controlled efficacy and an open-label, placebo-controlled long-term safety study. The studies are designed to determine the efficacy and safety of NKTR-118, a once-daily tablet, for the treatment of constipation in patients taking prescription opioid medications.

Vical (VICL)
Drug/indication: Allovectin in melanoma (phase III trial)
Top-line results expected in the fourth quarter
The phase III study compares Allovectin (injected directly into melanoma lesions) to dacarbazine or temozolomide in patients with recurrent metastatic melanoma. The primary endpoint of the study is durable response rate at 24 weeks but the more important and necessary (for approval) secondary endpoint is overall survival.
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