Biotech Clinical Trials Update: Roche, CytRx and Actelion

by: Roger Newman

This is one in a series of articles that highlight recent clinical trial updates for new drugs in the FDA approval process. A brief overview of the FDA approval process can be found here.

Roche Holdings (OTCQX:RHHBY) announced that a Phase 2 study of its compound lebrikizumab met its primary endpoint. In the study, treatment with lebrikizumab promoted a statistically significant increase in lung function in an adult with asthma whose symptoms were not sufficiently controlled with inhaled corticosteroids (i.e. Flovent). More than 20 million people suffer from asthma in the United States alone, with an annual estimated cost of $18 billion (for more click here). Two of the top 10 selling prescription medications, Advair Diskus and Singulair, are used to treat asthma (click here). Roche has a market cap of over $140 billion and is trading only 7% off its 52 week high.

Antares Pharma Inc. (AIS) reported positive results of a clinical study of VIBEXMTX in the treatment of rheumatoid arthritis. VIBEXMTX is an auto injector product designed for the quick administration of methotrexate vs. subcutaneous or intramuscular injection with a needle and syringe. The study found that all three methods provided quivalent performance. The advantage of the the VIBEXMTX administration is the ease in which self-administration can be achieved much like the commonly used Epipen. Rheumatoid Arthiris affects 1.3 million Americans. Enbrel is currently the best-selling RA treatment with 2010 sales of over $500 million (for more click here). Antares Pharma is traded on AMEX with a market cap of $225 million.

CytRx Corporation (NASDAQ:CYTR) reported that its compound INNO-206 achieved complete remissions in aggressively growing in vovi ovarian cancer tumors. INNO-206 was evaluated against and in conjunction with doxorubicin, a commonly prescribed cancer treatment. The increased effectiveness of INNO-206 in conjunction with doxorubicin at lower doses was statistically significant when compared to doxorubicin alone. Also of note is the fact that administration of either drug by itself, at the highest tolerated doses, induced significant weight loss. Moderate doses, which induced the remissions, did not have this side effect. Phase 1b trial results in soft tissue sarcomas are expected in the coming months. Short interest is just 579,000 shares or 2.7 days to cover (click here) for this $63 million market cap company.

Actelion (OTCPK:ALIOF) announced that its compound ponesimod achieved its primary endpoint in a Phase 2b trial. Ponesimod is a selective S1P1 receptor designed to reduce the number of active inflammatory lesions in the brains of patients suffering from relapsing-remitting multiple sclerosis (click here). There were 464 patients enrolled in the study, the largest ever dose-finding study in this disease indication. An important secondary endpoint focused on the relapse rate which was reduced in a meaningfully significant manner. Actelion intends to begin discussions with regulatory authorities on Phase 3 trials.

These clinical updates are short summaries and should be used as a basis for further research. You should always perform your own due diligence. Many factors can determine whether a particular drug candidate will ever come to market or be profitable and biotech investing should be considered high risk.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

About this article:

Author payment: $35 + $0.01/page view. Authors of PRO articles receive a minimum guaranteed payment of $150-500.
Want to share your opinion on this article? Add a comment.
Disagree with this article? .
To report a factual error in this article, click here