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!

YM BioSciences JAK Inhibitor CYT387 Produces Meaningful Reductions Of Splenomegaly And Durable Transfusion Independence Responses

MISSISSAUGA, ON, Nov. 5, 2012 /PRNewswire/ - YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company advancing hematology and cancer related products, today reported interim results from the Phase I/II study of CYT387, a JAK1/JAK2 inhibitor currently being evaluated for the treatment of myelofibrosis, which were included in an abstract submitted to the American Society of Hematology in August 2012. Updated results will be presented in an Oral Session at the 2012 Annual Meeting of the American Society of Hematology to be held in Atlanta, Georgia on December 9, 2012.

"Treatment with CYT387 provides sustained transfusion independence in a substantial number of patients with myelofibrosis. In addition, many patients experience rapid, meaningful and durable reductions of splenomegaly and improvements of constitutional symptoms. CYT387 has also proven safe for patients and well-tolerated, even with prolonged administration of more than two and a half years," said Mark Kowalski, M.D., Ph.D., Chief Medical Officer and Vice President, Regulatory Affairs at YM BioSciences. "We look forward to expanding on these results at ASH when we report final nine-month data from this trial."

The CYT387 Phase I/II study enrolled 166 patients across six study sites. At the time the ASH abstract was submitted, the median duration of follow-up was 16.1 months (ongoing) with a range of 0.7 to 31.0 months (ongoing).

  • Durable transfusion independence responses were observed in more than half of the RBC transfusion dependent subjects with a maximal transfusion-free period exceeding two years and ongoing.  In addition, the percentage of all subjects requiring RBC transfusions substantially decreased over the treatment period.
  • Treatment with CYT387 resulted in rapid and sustained reductions in splenomegaly with a maximal response duration approaching two years.
  • The majority of subjects reporting constitutional symptoms at baseline experienced complete resolution or marked improvement by six months with measurable improvement within the first month of therapy.
  • Higher transfusion independence and spleen response rates were seen in the 300mg dose group compared to the 150mg QD or 150mg BID dose groups.
  • While 90% of subjects reported at least one treatment-related AE, the majority were reported as Grade 1.

For the first 60 consecutively enrolled subjects for whom the most mature data is available, the median follow-up period was 21.5 months (ongoing) with a range of 2.9 to 31.0 months (ongoing).

  • The anemia and spleen response rates in these subjects, per IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment), were 59% and 48%, respectively.
  • Among 33 of these subjects who were RBC transfusion dependent by IWG-MRT criteria, 70% achieved a minimum 12-week period without transfusions, with a maximal transfusion-free period of greater than two years and ongoing.

ASH Oral Session:

Title: Phase I/II Study of CYT387, a JAK1/JAK2 Inhibitor for the Treatment of Myelofibrosis Session Name: 634. Myeloproliferative Syndromes - Clinical: Myeloproliferative Neoplasms - Novel Therapies I Session Date:  Sunday, December 9, 2012; 4:30 PM - 6:00 PM (Presentation Time:  5:15 PM) Location:  Georgia World Congress Center, Room B213-B214

About CYT387:

CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases, which have been implicated in a family of hematological conditions known as myeloproliferative neoplasms, including myelofibrosis, and as well in numerous other disorders including indications in hematology, oncology and inflammatory diseases. Myelofibrosis is a chronic debilitating disease in which a patient's bone marrow is replaced by scar tissue and for which treatment options are limited or unsatisfactory. Both the U.S. Food and Drug Administration (FDA) and the European Commission have designated CYT387 an Orphan Drug for the treatment of myelofibrosis.

1 of 2

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!
DOW 16,883.21 -28.90 -0.17%
S&P 500 1,970.85 +0.90 0.05%
NASDAQ 4,462.3950 +19.6970 0.44%

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