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News for 'YMI' - (Research Reports for Day Traders: Alcoa, Ivanhoe Mines, General Electric, YM BioSciences, Procter & Gamble and Goldman Sachs)
VANCOUVER, British Columbia, Dec. 14, 2011 /PRNewswire via COMTEX/ --
Pennystocksinsiders.com (PSI) has issued insider trading reports and Equity
Research for the following companies: Alcoa (NYSE:AA), Ivanhoe Mines (NYSE:IVN),
General Electric (NYSE:GE), YM BioSciences (AMEX:YMI), Procter & Gamble
(NYSE:PG) and Goldman Sachs (NYSE:GS).
(Logo: http://photos.prnewswire.com/prnh/20111214/HK22486LOGO )
(Read full report by clicking the link below, you may need to copy and paste the
full link to your browser.)
Report Highlights:
Alcoa Inc. (NYSE:AA): By the end of Tuesday's trading, Alcoa Inc. fell US$0.31
(-3.32%) to US$9.04. Throughout the day, 25.37 million shares of Alcoa Inc.
exchanged hands as compared to its average daily volume of 28.46 million shares.
It is a clever way to check if insiders like CEOs, CFOs, and Directors in AA are
starting to buy more company shares. See insider trade report for AA here. Read
Full Report: http://www.Pennystocksinsiders.com/PR/121411A/AA/Alcoa.pdf
Ivanhoe Mines Ltd. (USA) (NYSE:IVN): Abnormal trading volume was found for
Ivanhoe Mines on Dec 13th, which reached 16.12 million shares, almost 5 times
heavier than usual day trading. Will it continue to go up? Find your answer by
adding IVN to your insider trade monitor here. Read Full Report:
http://www.Pennystocksinsiders.com/PR/121411A/IVN/IvanhoeMines.pdf
General Electric Company (NYSE:GE): In the past 52 weeks, General Electric share
prices have been bracketed by a low of US$14.02 and a high of US$21.65, and are
now at US$16.42, 17% above that low price. Want to trace the activities of
company insiders from now on? Check out the insider trading here. Read Full
Report: http://www.Pennystocksinsiders.com/PR/121411A/GE/GeneralElectric.pdf
Today Pennystocksinsiders.com also observed abnormal trade volume for the
following companies; insiders may involve trading in these companies. It will
take some time for insiders to report their trades. Read these reports and add
these companies into your Insider Trade Radar.
YM BioSciences Inc. (USA) (AMEX:YMI):
Read Full Report:
http://www.Pennystocksinsiders.com/PR/121411A/YMI/YMBioSciences.pdf
The Procter & Gamble Company (NYSE:PG):
Read Full Report:
http://www.Pennystocksinsiders.com/PR/121411A/PG/ProcterGamble.pdf
Goldman Sachs Group, Inc. (NYSE:GS):
Read Full Report:
http://www.Pennystocksinsiders.com/PR/121411A/GS/GoldmanSachs.pdf
More Individual Stock Reports & Sector Reports:
http://www.Pennystocksinsiders.com/mediaroom/
Insider Filing Source Reference: All observations, analysis and reports are
based on public information released by the U.S. Securities and Exchange
Commission.
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provide the investment community with the tools, software, and data necessary to
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Copyright (C) 2011 PR Newswire. All rights reserved
3 Biotechs Making Big Moves on Big News
By David Williamson | More Articles
December 13, 2011
Today, the Dow Jones Industrial Average (INDEX: ^DJI ) closed down 66 points after the Federal Reserve indicated it would not be providing more near-term stimulus to the economy. But as volatile as the broader market was -- having been up before the Fed's disappointing announcement -- significantly larger moves happened in the health-care sector. For instance, poor phase 2 results sent Endocyte (Nasdaq: ECYT ) shares down 63% today. EC145, its cancer-fighting drug candidate, was not shown to increase survival in a subset of ovarian cancer patients.
Let's take a closer look at some biotechs that also made moves today, albeit less dramatic than Endocyte's.
Alexza Pharmaceuticals (Nasdaq: ALXA ) announced that an FDA advisory committee reviewing Adasuve recommended approving the schizophrenia and bipolar disorder drug. Shares closed up 25% and tacked on an additional 7% after hours. Investors should be excited but need to keep in mind two key things. First, while the vote for efficacy was a decisive 17-1, the panel only recommended approval by a 9-8 margin (with one abstention). And secondly, the FDA always has final say -- always.
Avanir Pharmaceuticals (Nasdaq: AVNR ) saw shares plunge 12% after reporting a quarter that the market didn't appreciate. The company's top drug, Neudexta, which treats uncontrollable laughing and crying, has struggled to find much traction. Failing to launch has become increasingly common in recent months after Dendreon's (Nasdaq: DNDN ) Provenge missed expectations so badly that management pulled guidance, and since the heralded new lupus drug Benlysta earned Human Genome Sciences (Nasdaq: HGSI ) only $18.8 million last quarter. Neudexta fared even worse, producing just $4.3 million in quarterly revenue, bringing its 2011 total up to an even $7 million. Cash used in operations was $14 million, but Avanir is sitting on a decent war chest of nearly $82 million, so the company has some time to get things straightened out.
Finally, YM Biosciences (AMEX: YMI ) announced encouraging results for its phase 1/2 trial of myelofibrosis drug, CYT387. Phrases like "significant and durable responses" and "meaningful improvements" were thrown around as CYT387 was shown to keep patients transfusion-independent for a clinically relevant amount of time. The drug appears to have a solid safety profile as well. Shares were up 15%. It is still early in the process, but this definitely is reassuring for investors as they wait for the drug to progress through phase 3 trials that should start next year.
http://www.fool.com/investing/high-growth/2011/12/13/3-biotechs-making-big-moves-on-big-news.aspx
YM Biosciences Rises on Promising Study Data for Blood Drug
By Brett Chase Dec 13, 2011 1:00 pm
The biotech is still at least three years from bringing a drug to market that can rival competitor Incyte's Jakafi.
YMI 1.69 (+15.75%)
INCY 13.62 (-4.76%)
YM Biosciences (YMI) had a short-lived surge in stock price Tuesday morning after it announced its experimental drug for the blood disease myelofibrosis showed promise in early studies.
But after jumping more than 20% right out of the gate, the stock was trading up less than 14% to $1.66 midday Tuesday. The shares are down almost 40% in the past six months.
The potential some investors see in YM Biosciences is a lead drug that may be three years away from competing with the just-approved treatment Jakafi, which is sold by rival Incyte (INCY). Jakafi is considered a future blockbuster by some analysts and is the first of a new class of drugs known as Jak inhibitors to hit the market. (See Incyte CEO Touts Prospects of New Cancer Drug.)
YM Biosciences still has some work to do before it is close to proving its treatment, known as CYT387. Potential market approval is still years away but the just-released data a good start toward building the drug’s rep -- especially after somewhat disappointing results announced last June. (See Incyte Pulls Further Ahead of YM Biosciences.)
Myelofibrosis is a disease in which bone marrow is replaced by scar tissue. Because of scarring, the bone marrow is not able to make enough blood cells. Jakafi and CYT387 have similar profiles for safety and effectiveness (though, again, it should be noted that YM Biosciences is still in early stages of testing).
One key difference between the drugs, according to YM Biosciences execs, is that CYT387 has shown some effect in improving anemia, one of the effects of myelofibrosis.
Rodman & Renshaw analyst Reni Benjamin says YM Biosciences’ new data is good enough to draw the attention of other companies -- and that’s a key point. The biotech could use some muscle and a potential partnership is a catalyst for the company’s stock.
The “data adds strength to CYT387’s overall clinical profile and increases the value proposition for potential partners,” Benjamin says in a note Tuesday.
He predicts YM Biosciences could attract a partner that would pay as much as $1 billion in licensing milestones. On the other hand, the company could be taken over by a bigger rival, he says.
Benjamin recommends buying the stock and set a price target of $6 a share. He also notes Incyte’s $1.8 billion market value as a possible gauge for YM Biosciences’ ($190 million market cap) future valuation.
Read more: http://www.minyanville.com/businessmarkets/articles/biotech-sector-biotech-stocks-drug-stocks/12/13/2011/id/38375#ixzz1gTKA7fs7
Quite a few tid bits of good news today. As well as quite a bit of buzz of a partnership possibility. Looking nothing but good here!
hopefully power hour will will bring a run north we might close at the HOD
yeah, seems very likely....this one is getting ret to bust a move, I smell a partnership coming.....
Looks like it could close $1.90 plus. I would have stocked up at $1.50 if I had the cash.
you did, let's roll!!!!
I told you $10 open was not being greedy;) just waiting for the pipes to burst here! We might see quite a few NRs in a row now.
Pharma News: Alexza Pharmaceuticals, YM BioSciences
Alexza Pharmaceuticals (ALXA) said today the U.S. Food and Drug Administration’s psychopharmacologic advisory committee voted to recommend its schizophrenia and bipolar mania treatment Adasuve for approval.
The committee voted to recommend the drug be approved as a single dose in 24 hours when used with the FDA’s recommended risk evaluation and mitigation strategy.
The drug is an inhaled version of antipsychotic drug loxapine, delivered via Alexza’s Staccato system, which is aimed at treating the agitation resulting from schizophrenia and bipolar mania within 10 minutes.
Valeant Pharmaceuticals (VRX) is commercializing the treatment.
The FDA is not required to take the recommendation of its advisory panel, although it frequently does so.
Alexza shares are surging on the news.
YM BioSciences (YMI) is seeing particularly active trading following updated results of ongoing studies of its myelofibrosis treatment.
The treatment, CYT387, appears to demonstrate an ability to render and maintain myelofibrosis patients transfusion independent for clinically-relevant periods, while also improving other symptoms, according to a phase I and phase II study.
YM BioSciences shares are seeing a big gain in trading Tuesday.
http://www.forbes.com/sites/marketnewsvideo/2011/12/13/pharma-news-alexza-pharmaceuticals-ym-biosciences/?partner=yahootix
News for 'YMI' - (Pharma News: Alexza Pharmaceuticals, YM BioSciences)
Dec 13, 2011 (MarketNewsVideo.com via COMTEX) -- Alexza Pharmaceuticals (ALXA)
said today the U.S. Food and Drug Administration's psychopharmacologic advisory
committee voted to recommend its schizophrenia and bipolar mania treatment
Adasuve for approval.
The committee voted to recommend the drug be approved as a single dose in 24
hours when used with the FDA's recommended risk evaluation and mitigation
strategy.
The drug is an inhaled version of antipsychotic drug loxapine, delivered via
Alexza's Staccato system, which is aimed at treating the agitation resulting
from schizophrenia and bipolar mania within 10 minutes.
Valeant Pharmaceuticals (VRX) is commercializing the treatment.
The FDA is not required to take the recommendation of its advisory panel,
although it frequently does so.
Alexza shares are surging on the news.
YM BioSciences (YMI) is seeing particularly active trading following updated
results of ongoing studies of its myelofibrosis treatment.
The treatment, CYT387, appears to demonstrate an ability to render and maintain
myelofibrosis patients transfusion independent for clinically-relevant periods,
while also improving other symptoms, according to a phase I and phase II study.
YM BioSciences shares are seeing a big gain in trading Tuesday.
The preceding is a transcript of the MarketNewsVideo.com video published at:
http://www.marketnewsvideo.com/?id=201112ALXA121311&mv=1.
YMI
This statement suggest that YMI is undervalued by 10x.....
1.66 x 10 = $16.60?
maybe?
Based on the positive anemia response data released Monday, the current valuation gap between Incyte ($1.8 billion market cap) and YM Bio ($170 million market cap) is way too big even considering '387 is two or three years behind in clinical development. "It's a drug," said Crespi Monness Hardt analyst (and YM Bio supporter) Avik Roy, referring to '387.
YM Bio's Myelofibrosis Drug Is For Real
By Adam Feuerstein 12/12/11 - 06:37 PM EST
YM Biosciences(YMI_) appears to have a real myelofibrosis drug on its hands.
Highly anticipated results from a mid-stage and multi-center study of YM Bio's myelofibrosis drug CYT387 were released Monday night showing the ballyhooed (and controversial) anemia response maintained.
Of the 68 myelofibrosis patients who were transfusion dependent when the study started, 46% became transfusion independent for a minimum of 12 weeks and maintained hemoglobin levels equal to or above 8 g/dl.
Of the 26 transfusion-dependent patients treated with the 300 mg dose of '387, 62% became transfusion independent and maintained hemoglobin levels equal to or above 8 g/dl.
These '387 anemia response data are stronger and more credible than what was presented last spring because Monday's results are culled from many more patients enrolled at multiple clinical trial sites.
If '387 can reverse the anemia associated with myelofibrosis, it will have a legitimate superiority claim over Incyte's(INCY_) recently approved myelofibrosis drug Jakafi, which has no effect on anemia.
Based on the positive anemia response data released Monday, the current valuation gap between Incyte ($1.8 billion market cap) and YM Bio ($170 million market cap) is way too big even considering '387 is two or three years behind in clinical development. "It's a drug," said Crespi Monness Hardt analyst (and YM Bio supporter) Avik Roy, referring to '387.
YM Bio shares closed Monday at $1.46 but were up 24% to $1.81 in after-hours trading as the '387 data were released at the American Society of Hematology (ASH) annual meeting.
Myelofibrosisis is a disorder in which abnormal bone marrow stem cells produce scar tissue that replaces healthy marrow. Patients with myelofibrosis suffer from anemia and enlarged spleens. YM Bio's '387 and Incyte's Jakafi belong to a class of oral drugs that block the effects of Janus kinase (JAK) enzymes which play a role in diseases that cause bone marrow cells to grow uncontrollably.
The YM Bio phase I/II study enrolled 166 myelofibrosis patients across six study sites, treating them with 150 mg or 300 mg of '387 daily.
Of the 142 patients evaluable, 31% achieved a spleen response with a median duration of response not yet reached. Forty-nine percent of patients achieved more than a 50% maximal decrease in spleen size from baseline.
Measured by magnetic resonance imaging, the '387 spleen response rate was 64%, which is defined as a 35% drop in spleen volume.
Twenty percent of patients experienced mild peripheral neuropathy, while 33% of patients reported thrombocytopenia, or low platelet counts, with 6% grade 4. Twelve patients, or 7%, died during the core portion of the study.
--Written by Adam Feuerstein in Boston.
http://www.thestreet.com/_yahoo/story/11342594/1/ym-bios-myelofibrosis-drug-is-for-real.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Over exuberance. Its not a fair market since not everyone has the ability to trade after hours. I do see this as a bit of a positive, the drop in SP will let new investors in and if a partnership is announced then look out!
Until a partner is found, YM will be volatile stock.
The funds want the retail out, take as few with they as
possible when they run it. Pre-market is just casino trading,
YM has lots of upside. Its a Jan. Feb 2012 deal in my opinion. We should trade in a range from 1.50- 2 maybe without partner news before years end. Lot of traders selling and retail then gets worried and sells and of coarse bears pile it on.
Including today....I just don't understand such a down trend after a big opening and big news. Must be a ton of shorties out there.
I never planned on selling today. This is my first Bio stock, so trying to learn more about the movement. I understand the product well due to my background, but the movement has thrown me for a loop a time or two in the last few months.
Makes no sense to sell now.
Hedge funds gaming it. Retail then has no idea were its going.
So most sell and buy at the wrong time. I'm holding i believe a partner will come with capital and knowledge that can help YM in the next trials and bringing it to market. Remember incy was a 2 dollar stock until a partner came through. End of the year with a partner YM could be 3.50-4.00 a share....will see. IMO \
Remember the hedge funds like to take as few people with them as possible when they run it higher.
With all of the post/pre market volume, why do you think this went all of the way up to $2.19, then down to under $1.80?
Look for a partnership for YM. Novartis or another big player will come in with some big money to partner with YM. The dilution fear will then disappear. YM could have sold shares before the results but they didn't, i believe they have some deals on the table....imo
ymi mention in this incy report
Incyte Corp. (INCY: Buy; $25 Target Price) - YM Back In The Saddle But Still Incyte’s Game For A Few Years Investment Summary
Brean Murray Jonathan Aschoff
Phase 2 data presented by YM at ASH shows that competition for Jakafi could be, in our estimation, about 3.5 years away, as we project U.S. approval for YM’s CYT387 in mid-2015. YM, in our view, appears to have a real drug, but we have identified some caveats in equating CYT387 and Jakafi or viewing CYT387 as better. YM claims an anemia benefit, and clearly shows one especially with the 300mg QD dose, but there is no graph depicting hemoglobin levels over time, and reticulocyte data is also absent, both of which would have made a far stronger case. We also would appreciate seeing complete adverse event data, rather than only what was deemed to be drug related. Also, the 90 non-Mayo patients evaluable for spleen size had to have experienced less than 31% benefit in order for the 142 total patients to result in 31% benefit, given how much higher the benefit was in the 52 Mayo patients at ASCO. Regardless, the drug looks interesting and we expect a European trial to be conducted, as Jakafi being available in the U.S. would in one way or another likely compromise YM''s ability to run as clean a trial. A European Phase 3 program should suffice for U.S. approval.
YM completed the enrollment of 166 patients in total in the expanded Phase 1/2 trial. YM dosed 52 patients with 150mg QD of CYT387, 60 patients with 300mg QD, and 42 patients with 150mg BID. We note that dose titration (5mg at a time) with Jakafi may enable doctors to better arrive at a more appropriate patient dosage, as myelofibrosis is a strikingly heterogeneous disease with respect to symptoms and hematological parameters. We believe the greater flexibility with Jakafi dosing is a significant advantage.
It also appears that Jakafi may maintain the advantage of achieving a greater spleen reduction, as the Phase 2 data for Jakafi showed 49% of patients achieving a =50% decrease in palpable spleen length, but CYT387 yields a 33% rate of patients are achieving this overall and in the 300mg QD dose group which YM appears to be favoring for the Phase 3 trial dose. The 300mg QD dose group had the greatest transfusion independence rate of 65%, and YM likely views this as the differentiating factor necessary to market CYT387 against Jakafi. In the Phase 3 COMFORT-I trial, Jakafi achieved a 41% transfusion independence rate using the IWG criteria, so that relative anemia benefit still needs to hold up in a larger trial.
Jakafi is also beginning to show a statistically significant survival advantage, which we expect to continue to improve over time. On an ITT basis, COMFORT-I patients have a hazard ratio (HR) of 0.50 with a p-value=0.04 after 76 weeks. Additionally, after 51 weeks of median follow up there were only 13 (8.4%) deaths in the Jakafi arm versus 24 (15.7%) deaths in the placebo arm. We note that there is a survival improvement across all subgroups rather than the benefit being driven by a select few. The full overall survival analysis is shown in Exhibit 3, which details the relevant subgroups.
Price
$ 14.30
52-Week High/Low
$ 21.15 - 11.76
Shares Outstanding ( 000 )
126,260.00
Market Cap. ( 000 )
$ 1,805,518.00
Average Daily Volume ( 000 )
2,504.70
EPS
FY 10 A
FY 11 E
FY 12 E
Mar
$ (0.30)
$ (0.20) A
-
Jun
$ 0.02
$ (0.39) A
-
Sep
$ (0.25)
$ (0.40) A
-
Dec
$ 0.24
$ (0.39)
-
FY
$ (0.23)
$ (1.40)
$ (1.03)
Prior
-
up 40% over yesterday's close, hitting $2.19 already in pre-market activity......very nice!
NICE!!!!!!
YMI
YM BioSciences, Inc. (YMI) After Hours Trading
Pre-Market Charts | After Hours Charts
Dec. 12, 2011 Market Close: $ 1.46
After Hours Last:
Net / % Change
$ 2
.54 (36.99%)
After Hours High:
$ 2.04
After Hours Volume:
527,937
After Hours Low:
$ 1.46
Read more: http://www.nasdaq.com/symbol/ymi/after-hours#ixzz1gNFJHjmg
where u @, I'm drinkin tonight, lol!!!
What a great day, I put a long shot buy order for 10k shares for 1.44 before work today, just got home and realized it was filled. Took half of the table at 2.03. I'm buying drinks tonight..
truckin!!!!!
YMI $ 2.04
After Hours High: $ 2.04
After Hours Volume: 522,337
Good news. Thumbs up!
don't see anything here but positives....
"Anemia Response
Of the 68 patients who were transfusion dependent at baseline, to date 54% have become transfusion independent for a minimum of 12 weeks. The median duration of the transfusion-free period has not yet been reached (range: 82-506 days, ongoing). More than 25% of subjects who were not receiving transfusions while on study experienced at least a 1 g/dL increase in hemoglobin lasting for more than eight weeks.
Of the 26 patients who were dosed at 300mg QD and were transfusion dependent at baseline, to date 65% have become transfusion independent for a minimum of 12 weeks."
These #s are actually better than the earlier interim results, which had percentages of 50% and 58%.
Doin well, and yes, I will try to order a $10 open....I wish, lol!
How ya doin Harleyman? Could you arrange an open of $10 please;) Sure wish Id hit more on those crazy few days 2 weeks ago. Oh well.
Trading currently at $1.78 after hours....up 22%.....looks like the news is well received...volume is low so nothing off the charts yet!
News for 'YMI' - (YM BioSciences Reports Updated Phase I/II Data for its JAK1/JAK2 Inhibitor CYT387 at ASH 2011)
MISSISSAUGA, ON, Dec. 12, 2011, 2011 (Canada NewsWire via COMTEX) -- -
Significant and durable responses in anemia, splenomegaly and constitutional
symptoms reported - - Well tolerated for dosing periods up to and exceeding two
years - - MRI results confirm meaningful improvements in splenomegaly -
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), today reported updated results
from the ongoing Phase I/II study of its JAK1/JAK2 inhibitor, CYT387, for the
treatment of myelofibrosis. The results are being presented this evening in a
poster session at the 53rd Annual Meeting of the American Society of Hematology
underway in San Diego, CA.
"In this multicenter study, CYT387 continues to demonstrate a unique ability to
render and maintain myelofibrosis patients transfusion independent for
clinically-relevant periods, while also producing significant and durable
improvements in their splenomegaly and constitutional symptoms," said Dr. Nick
Glover, President and CEO of YM BioSciences. "In addition, MRI results obtained
from a subset of subjects confirm the meaningful improvements in splenomegaly as
measured by palpation. Moreover, CYT387 was well tolerated, with dosing up to
and exceeding two years."
"While additional assessments and analyses are ongoing across dose levels, 300
mg/day appears to be a safe and effective dosing regimen that warrants further
clinical development," added Dr. Glover. "We look forward to leveraging these
data to advance our regulatory strategy and our business development activities
with the goal of starting pivotal trials in mid-2012."
Phase I/II Study Updated Results
Study Design The Core Phase I/II study has completed enrollment of 166
myelofibrosis patients across six study sites. The Core study consists of nine
28-day treatment cycles where CYT387 is orally self-administered, primarily at
dosages of 150 mg once-daily (QD), 300 mg QD or 150 mg twice-daily (BID).
Patients who tolerate and benefit from the drug may continue to receive CYT387
beyond the Core study in an Extension phase. While data collection and analysis
are ongoing, preliminary safety and efficacy results from this multicenter study
are presented below.
Subject Characteristics The majority of the 166 patients enrolled have Primary
Myelofibrosis (65%); 22% have Post-Polycythemia vera and 14% have Post-Essential
thrombocythemia. Other patient characteristics include:
-- DIPSS-Plus category: Int-1 - 11%; Int-2 - 61%; High - 28%
-- JAK2V617F positive: 76%
-- Red blood cell transfusion-dependent: 44%
-- Palpable splenomegaly >10 cm: 80%
The trial also enrolled patients who had received previous therapies, including
other JAK inhibitors (12%) and IMiDs (9%).
Subject Disposition The median follow-up time for patients in the Core study and
Extension phase is 10.4 months (range: 0.8-25.6 months; ongoing). To date, 97%
of patients who have completed the Core study have continued into the Extension
phase. During the Core study, 32 patients (19%) have discontinued the study,
five for possibly or probably related adverse events, for a current overall
retention rate of 81%. The retention rate during the Extension phase is
currently 79%.
Anemia Response Of the 68 patients who were transfusion dependent at baseline,
to date 54% have become transfusion independent for a minimum of 12 weeks. The
median duration of the transfusion-free period has not yet been reached (range:
82-506 days, ongoing). More than 25% of subjects who were not receiving
transfusions while on study experienced at least a 1 g/dL increase in hemoglobin
lasting for more than eight weeks.
Of the 26 patients who were dosed at 300mg QD and were transfusion dependent at
baseline, to date 65% have become transfusion independent for a minimum of 12
weeks.
Spleen Response Of the 142 patients evaluable for spleen response, 31% achieved
a response per IWG-MRT*. The median duration of spleen response has not yet been
reached (range: 55 - 574 days, ongoing). The median time to spleen response was
15 days (range: 6 - 260 days, ongoing). To date, 49% of patients achieved more
than a 50% maximal decrease in spleen size from baseline, with 87% achieving
more than a 25% maximal decrease.
Of the 51 patients who were dosed at 300mg QD and were evaluable for spleen
response, 33% achieved a response per IWG-MRT.
Eleven patients were evaluable for spleen response both by MRI and by palpation.
The response rate was 64% by MRI (defined as a 35% decrease in spleen volume)
and 45% by palpation (defined as a 50% decrease in spleen length). The median
splenic decrease from baseline at three months was -41% by volume measured by
MRI and -45% by length measured by palpation.
*International Working Group for Myelofibrosis Research and Treatment
Constitutional Symptoms Response The majority of patients reporting
constitutional symptoms at baseline demonstrated a Complete Resolution or Marked
Improvement of their symptoms, including night sweats, pruritus and bone pain.
Safety Results CYT387 is well tolerated in myelofibrosis patients for dosing
periods up to and exceeding two years. Reported adverse effects include
thrombocytopenia; transient, mild dizziness; mild peripheral neuropathy; and
abnormalities in liver/pancreas-related laboratory tests. Treatment emergent
anemia and neutropenia were rarely reported.
Poster presentation and YM conference call: The updated results from the Phase
I/II study will be presented in a poster session at the 53rd Annual Meeting of
the American Society of Hematology. Poster #3849, entitled "Safety and Efficacy
of CYT387, a JAK1 and JAK2 Inhibitor for the Treatment of Myelofibrosis", will
be presented at Session #634, Myeloproliferative Syndromes: Poster III, being
held on Monday, December 12th from 6:00-8:00pm PT in Hall GH of the San Diego
Convention Center.
YM will also host a webcast meeting open to members of the investment community
to discuss these results. This event will be held from 6:30-7:30am PT on
Tuesday, December 13th in the Grand Ballroom of the Hotel Palomar, 1047 Fifth
Avenue, San Diego. Access to the webcast will be available from YM's website at
www.ymbiosciences.com or at www.newswire.ca. The event can also be heard by
dialing in to (647) 427-7450 or toll-free at (888) 231-8191.
About CYT387: CYT387 is an inhibitor of the kinase enzymes JAK1 and JAK2, 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.
YM BioSciences retains full global commercialization rights to CYT387.
About YM BioSciences YM BioSciences Inc. is a drug development company advancing
three products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2
kinases; nimotuzumab, an EGFR-targeting monoclonal antibody; and CYT997, a
vascular disrupting agent (VDA).
CYT387 is an orally administered inhibitor of both the JAK1 and JAK2 kinases,
which have been implicated in a number of immune cell disorders including
myeloproliferative neoplasms and inflammatory diseases as well as certain
cancers. CYT387 is currently in a 166 patient Phase I/II trial in myelofibrosis
that has completed enrollment, as well as a 60 patient Phase II BID trial that
is recruiting patients. Nimotuzumab is a humanized monoclonal antibody targeting
EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. CYT997 is an orally-available small molecule therapeutic with dual
mechanisms of vascular disruption and cytotoxicity, and has completed a Phase II
trial in glioblastoma multiforme. In addition to YM's three products, the
Company has several preclinical research programs underway with candidates from
its library of novel compounds identified through internal research conducted at
YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the
Company's current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at standards acceptable
to health regulatory authorities to complete clinical trials or to meet
commercial demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions made in
preparing forward-looking statements include but are not limited to the
following: that CYT387, nimotuzumab and CYT997 will generate positive efficacy
and safety data in ongoing and future clinical trials, and that YM and its
various licensees will complete their respective clinical trials and disclose
data within the timelines communicated in this release. Except as required by
applicable securitieslaws, we undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
To view this news release in HTML formatting, please use the following URL:
http://www.newswire.ca/en/releases/archive/December2011/12/c6104.html
SOURCE: YM BioSciences Inc.
six, tonight is their CYT 387 poster, here is a clip from an article I read this morning!
YM Biosciences(YMI_) will be presented highly anticipated data on its myelofibrosis drug CYT387 during a Monday night poster session starting at 9 pm ET.
"Several key opinion leaders we spoke with said they believe '387's anemia benefits are real, even though they do not expect it to be quite as robust as previous results and do not have a scientific explanation for these effects," writes Wells Fargo biotech analyst Brian Abrahams.
Sally Church, a cancer drug consultant who co-writes the popular Biotech Strategy Blog, tweeted last might, "Going to call it and say we won't see Hb [hemoglobin] increase with $YMI in tomorrow's #ash11 poster. Storm in a teacup."
So selling pre news isn't uncommon in this arena!!! Just MO!
if you believe that data should be good , buy it. if you believe data will be bad sell it, as simple as that. i am holding i think data will be good, i dont care about short term price, it will catch up eventually.
I have not been in this stock too long, but I am very confused about the movement. Any thoughts on what is going on today?
I love this paragraph:
"Conclusions: When examined in an expanded, multicenter study, CYT387 continues to show substantial clinical activity in myelofibrosis, with improvements in splenomegaly, constitutional symptoms and anemia. It appears to be well tolerated when administered in either a once or twice daily dosing regimen. CYT387 continues to demonstrate an ability to induce durable anemia responses in a subset of subjects. Detailed analyses of safety and efficacy will be available at the time of the meeting. "
ASH abstract states transfusion independence and strong anemia benefit
3849 An Expanded Multicenter Phase I/II Study of CYT387, a JAK- 1/2 Inhibitor for the Treatment of Myelofibrosis
Program: Oral and Poster Abstracts
Session: 634. Myeloproliferative Syndromes: Poster III
Monday, December 12, 2011, 6:00 PM-8:00 PM
Hall GH (San Diego Convention Center)
Background: CYT387 is a potent JAK-1/2 inhibitor. The maximum tolerated dose (MTD) and preliminary safety and efficacy of once daily dosing of CYT387 were determined in a single center Phase I/II study. Previously reported results from the first 60 subjects enrolled in this study determined a MTD of 300 mg QD and demonstrated improvements in splenomegaly and constitutional symptoms as well as in RBC transfusion requirements. The study was expanded into a multicenter study with planned accrual of 165 subjects at 6 study sites and a twice daily dosing arm was added. The preliminary safety and efficacy results from this expanded multicenter study will be presented.
Methods: Subjects with high or intermediate-risk primary myelofibrosis (PMF) and post-polycythemia vera (post-PV) or post-essential thrombocythemia (ET) myelofibrosis were enrolled. In the core expansion study, oral CYT387 was administered either once daily at 150 mg or 300 mg or twice daily at 150 mg for 9 months. Patients who maintained at least stable disease were permitted to continue CYT387 treatment beyond 9 months in an extension phase of the study. Responses were assessed by International Working Group (IWG) Criteria.
Results: At present, 163 subjects have been enrolled across the 6 study sites. The diagnoses of enrolled subjects include 64% PMF, 14% post-ET MF and 22% post-PV MF; 67% of the patients were JAK2V617F positive. Starting doses of CYT387 in the dose escalation, confirmation and expansion phases of the study are shown in Table 1.
Table 1. CYT387 Starting Dose by Cohort Dose
100mg QD
150 mg QD
200mg QD
300mg QD
400mg QD
150mg BID
Total
n (%)
3 (1.8)
52 (31.9)
3 (1.8)
60 (36.8)
6 (3.7)
39 (23.9)
163 (100)
The median duration (range) of treatment was 6.6 months (0.25 to 20.4 months). Patient characteristics were as follows: median age 68 years, 58% male, 87% were spleen evaluable at baseline per IWG criteria (median spleen length was 18 cm by palpation). Sixty three percent (63%) of subjects were anemia evaluable at baseline per IWG criteria; 46% were transfusion dependent. Previous JAK inhibitor and IMiD therapy was reported for 11% and 8% of enrolled subjects, respectively. Reductions in spleen size, improvements in constitutional symptoms and the achievement of transfusion independence were observed in subjects in the expanded multicenter study.
CYT387 was well tolerated. Based on currently available data, 73% of subjects reported treatment-related adverse events, with the majority reported as Grade 1. The most common Grade 3-4 treatment related adverse events included thrombocytopenia (16%), and hyperlipasemia (3%). New onset treatment-related Grade 3-4 anemia remains rare (<1%). Grade 1 toxicities included peripheral sensory neuropathy whose incidence and natural history is currently being studied. Twenty-five of 163 subjects (15%) have discontinued from the 9 month core study giving a retention rate of 85%.
Conclusions: When examined in an expanded, multicenter study, CYT387 continues to show substantial clinical activity in myelofibrosis, with improvements in splenomegaly, constitutional symptoms and anemia. It appears to be well tolerated when administered in either a once or twice daily dosing regimen. CYT387 continues to demonstrate an ability to induce durable anemia responses in a subset of subjects. Detailed analyses of safety and efficacy will be available at the time of the meeting.
Is this what we can expect tomorrow?
http://ash.confex.com/ash/2011/webprogra...
Ugh...green all day with a few too many sells at the end of the day. Green 4/5 days this week. Hopefully we can pick up where we left off on Monday. Have a good weekend all!
I hope you are right about YMI...(and wrong about MC). Good News Monday would be HUGE! We have already had 4.5 days of green trading this week, positive news should make this run IMO.
I think that's a good possibility after that who knows. it could keep the momentum I am just saying that people sell into news. I had a few stocks that after an FDA approval the next day they dropped like a rock, but hey they are all different GLTA hopefully we keep heading north.
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YMI BioSciences, Inc.
CYT997 has completed two Phase I studies in advanced solid tumors and is currently being studied in a Phase II clinical trial in combination with chemotherapy in patients with relapsed glioblastoma multiforme. Results from the intravenous Phase I dose escalation study were published in the British Journal of Cancer (Lickliter et al, 2010), and demonstrated clinically meaningful disease stabilization in the majority of patients treated. Data showed that CYT997 administration was associated with changes in plasma and imaging biomarkers consistent with vascular disruption in tumors. Magnetic resonance imaging showed significant changes in tumor perfusion consistent with vascular disruption in some patients. Data from the Phase I oral study of CYT997 in patients with advanced cancer were reported at ASCO 2009 (Francesconi et al, 2009).
2011 2nd Quarter http://www.ymbiosciences.com/upload_files/YM_Q2_2011.pdf
2011 3rd Quarter http://www.otcmarkets.com/stock/YMI/news
2010 Annual Report 10-K http://www.ymbiosciences.com/upload_files/YM_AR_2010.pdf
Website http://www.ymbiosciences.com/
Yahoo Finance http://finance.yahoo.com/q/h?s=YMI
Google Finance http://finance.google.com/finance?client=ob&q=YMI
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