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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Biotech Stock Mailbag: Exact Sciences, Rexahn, Advaxis, Peregrine

Stocks in this article: EXAS RNN ADXS PPHM BMY TEVA LLY



Robert K. emails: "If you get a chance could you take a quick look at Advaxis (ADXS). Something just isn't adding up. Thanks for your time."

Advaxis lead product ADXS-HVP is a "cancer vaccine" consisting of listeria bacteria engineered to produce antigens that are supposed to stimulate the patient's immune system to recognize and kill cancer cells associated with HPV.

Last fall, Advaxis announced results from a phase II study of ADXS-HVP in patients with recurrent cervical cancer. The study was randomized but not in a way that allows for the best assessment of the vaccine's efficacy: 110 women with recurrent cervical cancer were all treated with ADXS-HVP but half the women were also administered the chemotherapy drug cisplatin.

What you'd rather see in this phase II study is half the cervical cancer patients treated with ADXS-HVP plus cisplatin and the other half treated with cisplatin alone as a true control arm.

The results: No difference in overall survival between the two arms of the study, with median overall survival of 8.5 months. At 12 months, 36% of patients across both arms were alive; at 18 months, 28% of patients were alive. The overall response rate for all 110 patients was 11% -- again, no difference between the two treatment arms.

Advaxis described these phase II data last November as "encouraging" and supportive of moving ADXS-HPV into more advanced clinical trials. The reason given for optimism was a comparison of the ADXS-HPV data to a 2004 phase III study by Moore et al which compared cisplatin to cisplatin and paclitaxel in patients with recurrent cervical cancer.

The Moore study reported median overall survival of 8.9 months for cisplatin versus 9.9 months for cisplatin/paclitaxel -- a difference that was not statistically significant. Response rates were 19% for cisplatin and 36% for cisplatin/paclitaxel.

An objective comparison between these two studies doesn't exactly justify the optimism which Advaxis claims to see in the ADXS-HPV data. If the vaccine were truly effective, we should be seeing a stronger synergistic effect between ADXS-HPV and cisplatin. Instead, we see a median overall survival of 8.5 months for ADXS-HPV plus cisplatin in the Advaxis study compared to 8.9 months for cisplatin alone in the Moore study. Not exactly confidence inspiring.

One more important distinction between these two studies: Advaxis conducted its phase II study of ADXS-HPV entirely in India, while the Moore study was conducted in the United States by leading academic institutions. The latter study has more credibility.

Unfortunately, I'm not sure Advaxis' next step with ADXS-HPV will tell us much more about the vaccine's efficacy. An ongoing, U.S.-based phase II study is set up to enroll only 67 patients with recurrent cervical cancer. The study isn't randomized and has no control arm.

3 of 4

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
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!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

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