More than any other catalyst, the release of data from big clinical trials moves biotech stocks.

As a companion piece to my recent list of biotech stocks facing

FDA approval decisions, I put together a new list and calendar of biotech companies with ongoing phase III studies.

Phase III clinical trials are typically the final arbiter for a new drug's efficacy and safety. With positive results, biotechs can typically move on to seek marketing approval; negative results mean a trip back to the lab for more research.

This database includes more than 100 phase III clinical trials being conducted by 64 different companies. I limited my research to biotech and small drug companies, which means I excluded Big Pharma. I also only looked for phase III studies expected to be completed this year and next.

I used


, a subscription research service, as the starting point for my phase III clinical trial list, which I then supplemented and narrowed with analyst research and company reports.

Detailed below are 10 companies with phase III studies culled from the master list, each with clinical data that should be released in 2007.

I've said it before but it bears repeating: Investing successfully in biotech requires paying close attention to the biotech events calendar. With that in mind, I hope you can use this clinical trial list and calendar as the starting point for further research.

Arena Pharmaceuticals

(ARNA) - Get Report

Drug: Lorcaserin

Indication: Obesity

Results expected: Fourth quarter 2007 to first quarter 2008

Clinical studies for obesity drugs are large, and the Lorcaserin phase III studies are no exception. Arena completed enrollment of more than 3,100 patients into its phase III Bloom study in February 2007. A six-month safety analysis is expected in September 2007, followed by a 12-month safety look in the first quarter 2008.

Negative safety data, particularly any potential cardiovascular side effects, are an ongoing concern for any obesity drug in development, including Lorcaserin. Therefore, passing ongoing safety checks with a green light is a positive signal.

Arena is expected to run two additional phase III studies of Lorcaserin beginning this year, raising total enrollment to 6,000 patients. All three studies could be completed in early 2009.



Drug: Favid

Indication: B cell non-Hodgkin's lymphoma

Results expected: Fourth quarter 2007

Favid is a personalized cancer "vaccine" designed to stimulate a patient's immune system to identify and kill cancer cells. The phase III study in patients with non-Hodgkin's lymphoma was started in July 2004 with enrollment completed in January 2006.

The study's primary endpoint is time to tumor progression, with Favid administered to patients following treatment with existing standard-of-care drugs as a way to extend the time before patients relapse.



Drug: MyVax

Indication: B cell non-Hodgkin's lymphoma

Results expected: Fourth quarter 2007

MyVax is another cancer "vaccine," and like Favrille's Favid, is being developed as a treatment for non-Hodgkin's lyphoma. Genitope has already conducted several interim analyses of its phase III MyVax study with no success, meaning that the data weren't sufficient to show a clinical benefit. Final results are expected before the end of the year.



Drug: Acapodene

Indication: Amelioration of side effects associated with androgen deprivation therapy; prevention of prostate cancer in men with high-grade prostatic intraepithelial neoplasia -- a type of precancerous lesion.

Results expected: Fourth quarter 2007 to first quarter 2008

GTx is studying Acapodene in two pivotal phase III studies related to prostate cancer. The first investigates Acapodene treatment for the reduction of side effects associated with hormone (androgen deprivation) therapy; the second seeks to determine whether Acapodene can prevent prostate cancer in men diagnosed with high-grade PIN, which makes puts them a greater risk for the disease.

ImClone Systems


Drug: Erbitux

Indication: Non-small-cell lung cancer

Results expected: Second half 2007

ImClone and its Erbitux partners

Bristol-Myers Squibb

(BMY) - Get Report


Merck KGaA

are running multiple phase III studies investigating Erbitux treatment in combination with chemotherapy for patients with non-small-cell lung cancer. Erbitux is currently approved as a treatment for colon cancer and head-and-neck cancer patients.

Earlier this month, negative results from the first of these Erbitux lung cancer trials were announced. Data from the other studies is expected later this year.



Drug: Ipilimumab

Indication: Melanoma (skin cancer)

Results expected: Second half 2007

Medarex has an extremely deep drug pipeline, mainly through partnered programs, but the big value driver in the near term is Ipilimumab, or MDX-010, another cancer "vaccine" that proceeding through multiple pivotal clinical studies.

Expect the first data later this year from a phase II study of Ipilimumab as monotherapy treatment in second-line melanoma patients. Medarex has stated that this single-arm study, if positive, will form the basis of an approval filing with the FDA.



Drug: Alzhemed

Indication: Alzheimer's disease

Results expected: Second half 2007

Data from the highly anticipated study of Alzhemed in Alzheimer's patients was supposed to be released earlier this year, but it's been delayed. Why? It depends on whom you ask. Neurochem continues to insist that an analysis is not ready because it's making changes to the statistical plan. Naysayers believe the study failed and Neurochem is fishing around the data looking for something positive to report.

Pain Therapeutics


Drug: Remoxy

Indication: Pain

Results expected: Fourth quarter 2007

Remoxy is designed to be a long-acting, abuse-resistant formulation of the painkiller oxycodone, but its development has been slowed by delays. A phase III trial in patients with severe pain was expected to be completed by midyear, but slow patient enrollment has pushed completion and results to the end of the year.

A previous phase III study of Remoxy in patients with moderate to severe osteoarthritis was completed successfully in December 2004. Last year, Pain Therapeutics signed a partnership with

King Pharmaceuticals

( KG) for Remox and other abuse-resistant painkillers.

Sonus Pharmaceuticals

( SNUS)Drug: Tocosol Paclitaxel

Indication: Breast cancer

Results expected: Third quarter 2007

Sonus' Tocosol drug-delivery technology is designed to make standard chemotherapy agents easier to administer, less toxic and possibly even more effective. The first demonstration of this technology will come in the third quarter, when data from a phase III study of Tocosol paclitaxel in breast cancer patients are released.

The phase III study enrolled 800 patients, with a primary endpoint of response rate (tumor shrinkage) in a non-inferiority comparison to standard paclitaxel.

United Therapeutics

(UTHR) - Get Report



(REX) - Get Report

Drug: Ovarex

Indication: Ovarian cancer

Results expected: Second half 2007

Ovarex is another cancer vaccine designed to help a patient's immune system find and destroy any residual tumor cells that might linger after surgery and chemotherapy. Two phase III studies of ovarian cancer patients are now fully enrolled, with the goal of prolonging the time before cancer relapse. Data from the studies are expected in the second half of 2007.

Below are more than 100 drugs in ongoing phase III studies.

Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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