This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Cramer's Action Alerts PLUS - See his portfolio and get alerts BEFORE every trade. Learn more NOW!

Biotech Stock Mailbag: Vical, Hep C Drugs

The assumption of a 4% response rate in the control arm comes from a failed phase III study of Genta's (GNTA) Genasense compared to DTIC. However, patients enrolled in the Genasense/DTIC study were sicker and had more negative baseline prognostic factors. This makes it likely that the control arm in the Allovectin study is going to perform better than Vical expected, as enrollment is being restricted to "less sick" melanoma patients like it was in the phase II study.

If the temozolomide/DTIC arm of the phase III study outperforms, so too must the Allovectin arm, which seems very unlikely given the previous data.

A couple more notes:

The Allovectin study is being run under an SPA that allows for a durable response rate primary endpoint, but since the study started two melanoma drugs (Bristol's Yervoy and Roche's (RHHBY) Zelboraf) were both approved based on clinical trials that demonstrated an improvement in overall survival. Even Vical now acknowledges that Allovectin probably must also demonstrate a survival benefit in order to be approved.

Once upon a time, Vical ran a phase III study of Allovectin in combination with DTIC that failed. Granted, this study used a lower dose of Allovectin but still, failure is a failure.

"PHavna84" writes, "With all the attention given to hepatitis C drug stocks today, I still don't understand the differences with these drugs and what makes one drug better than the other. Can you explain?"

Thanks for the great question. I write about these new hepatitis C drugs all the time but sometimes neglect to explain, for example, why investors today are more deeply in love with the so-called "nucs" than "protease inhibitors." Let me try to explain the differences between these classes of antiviral drugs as simply as possible.

First, let's step back and remind everyone that all of these newly approved and experimental hepatitis C drugs act directly against the hepatitis C virus, meaning they interfere with or block enzymes that the virus requires to copy itself or make a comfortable home in a patient's cells. You'll often hear these drugs referred to as "direct-acting antivirals, or DAAs. All of these drugs are pills.

It's not precisely known how interferon and ribavirin, the previous standard therapy for hepatitis C, work against the virus but it's believed the two drugs do help stimulate the body's immune system to recognize and attack the virus. In other words, the drugs work indirectly, at least partly. Interferon needs to be injected once a week.

2 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG
ACHN $11.37 3.50%
BMY $65.13 -1.40%
GILD $101.88 -1.50%
IDIX $24.50 0.20%
VICL $0.99 -3.90%

Markets

DOW 17,842.49 -293.23 -1.62%
S&P 500 2,069.85 -31.19 -1.48%
NASDAQ 4,923.8630 -58.9460 -1.18%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs