This Day On The Street
Continue to site
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

Bristol-Myers Squibb Presents Promising Phase IIb Data For Novel, Investigational Attachment Inhibitor For HIV-1 Infected Treatment-Experienced Patients

Bristol-Myers Squibb Company (NYSE:BMY) today presented 24-week Phase IIb data that demonstrated similar response rates (HIV-1 RNA <50 c/mL) for its investigational compound, BMS-663068, when compared to a boosted protease inhibitor, Reyataz® (atazanavir sulfate) with ritonavir. Among HIV-1 infected treatment-experienced patients receiving BMS-663068, 69-80% had HIV-1 RNA levels of <50 c/mL (a measure indicating virus replication is undetectable), compared to 75% of patients taking Reyataz with ritonavir. Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) today, this study highlights the unique mechanism of action of the investigational prodrug BMS-663068, which when converted into BMS-626529, a novel attachment inhibitor, prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.

Globally, there are 34 million people who are infected with HIV. Due to significant scientific advances in management of HIV treatment over the last 20 years, patients are now living with HIV for a longer period of time and some patients have developed resistance to existing regimens or are unable to tolerate current available treatments. Additional treatment options, especially in new drug classes, are needed both today and into the future for these patients.

“By targeting the virus at an earlier step of the viral lifecycle, BMS-663068 disrupts the virus in a way unlike existing antiretroviral agents,” said Jacob P. Lalezari, M.D., director of Quest Clinical Research and assistant clinical professor of medicine at UCSF/Mount Zion Hospital. “The data suggest that BMS-663068 is potentially as effective as one of the current standards of care and may provide another method of suppressing the virus in treatment-experienced patients who have failed a prior HIV regimen and need new treatment options.”

Study Design and Results

In this active-controlled Phase IIb study, treatment-experienced HIV-1 infected adults (n=254) were randomized equally to one of four BMS-663068 treatment arms: (400 mg BID (twice daily); 800 mg BID; 600 mg QD (once daily); 1200 mg QD) and, a control group of Reyataz® (atazanavir sulfate) and ritonavir (300/100 mg QD). Each treatment arm and the control group also included raltegravir (RAL) 400 mg BID and tenofovir disoproxil fumarate (TDF) 300 mg QD. The primary endpoints were the proportion of subjects with HIV-1 RNA <50 c/mL at week 24 and the frequency of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation through week 24.

Through week 24, BMS-663068 showed similar efficacy compared to Reyataz and ritonavir for treatment-experienced patients infected with HIV-1. Specifically, 69-80% of patients in the four treatment arms had HIV-1 RNA levels <50 c/mL, indicating virus replication was undetectable, compared to 75% of patients in the control group.

BMS-663068 was generally well-tolerated during the study, with no serious adverse events attributed to BMS-663068 nor any adverse events leading to discontinuation. The incidence of Grade 2-4 related AEs across BMS-663068 arms ranged from 3.9% to 12%, vs. 27.5% in the comparator arm (atazanavir sulfate and ritonavir) and no causal association was observed between adverse events and BMS-663068 dose.

1 of 3

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
Only $9.95
14-Days Free
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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.75 -1.10%
FB $117.53 0.69%
GOOG $693.00 0.29%
TSLA $240.75 -2.80%
YHOO $36.61 0.06%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs