This study is actually the first of four placebo-controlled, Phase III trials to be completed.
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Last year, Enzon Pharmaceuticals terminated its co-development agreement with Inex after the FDA issued a "non-approvable" letter for Marqibo, saying Phase III trials were necessary.
Amylin Pharmaceuticals (nasdaq: AMLN - news - people ) is in phase III trials of Exenatide, a drug that promises to treat Type 2 diabetes.
The vaccine, called AIDSVAX, is currently undergoing Phase III trials.
Biologics now account for half the products currently in Phase II and Phase III clinical trials.
DC, says that if any of the six phase-III trials were to come up trumps, a product could be on the market within five years.
On its recent Q4 conference call with analysts Pfizer confirmed the likely progression of its own Herceptin biosimilar program into Phase III clinical trials later this year.
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In addition, the experimental insomnia drug Suvorexant exhibited strong efficacy in phase III clinical trials as the drug helped insomnia patients fall asleep faster and stay asleep longer versus a placebo.
This was done before and after key public announcements were made between January 2000 and January 2009 about 23 positive and 36 negative phase III clinical trials in which a cancer drug was tested.
FORBES: Why Pharma Stocks May Rise Before Trial Data Is Released
This is unlikely to surprise some investors, but a new study has determined that advanced knowledge of Phase III clinical trials of new cancer meds and FDA decisions may affect the publicly traded shares prices of drugmakers.
FORBES: Why Pharma Stocks May Rise Before Trial Data Is Released
However, in the case of Nexavar, Phase III clinical trials with 602 patients showed that it extended the life of the average patient by 2.8 months to 10.7 months, as compared to patients who received a placebo.
In addition, and more specific to the sector, any bull market for the sector will come to an end if or when high profile drugs start to fail Phase III clinical trials or the Food and Drug Administration turns down a high profile drug that everyone was certain would be approved.
When Lilly released results of its Phase III Expedition trials two months ago, the findings indicated that cognitive decline was slowed by 42 percent in patients in the early stages of the disease in one trial, and there were also positive signs from another trial, although the showing was not statistically significant.
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Instead, Genta skipped directly to large-scale "phase-III" trials comparing Genasense to standard chemotherapy on many hundreds of patients in an all-or-nothing bet to prove the drug worked.
Late-stage, or Phase III, clinical trials should begin soon.
This year, when Tularik prepared to move into late-stage, or phase-III, trials for T67, it decided that it would make more sense to use a higher dose of the chemical in the liver cancer patients.
In some ways it is like a biotech company doing all it can to hold things together to bring a promising new drug through trials to Phase III testing before selling it off to a major with the sacks of money to bring it to market.
They analyzed each closing stock price before and after the date of a public announcement and found that the average stock price 120 days before a phase III clinical trial announcement showed an increase of 13.7 percent for companies that reported positive trials and a 0.7 percent drop for those reporting negative trial results ( here is the abstract).
FORBES: Why Pharma Stocks May Rise Before Trial Data Is Released
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