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Such a low flot be back to .60 before we know it!
nice news after hours on BNVI
Bionovo Initiates Menerba (MF101) Phase 3 Clinical Trial for Menopausal Hot Flashes
Press Release Source: Bionovo, Inc. On Wednesday October 26, 2011, 4:38 pm
EMERYVILLE, Calif., Oct. 26, 2011 /PRNewswire/ -- Bionovo, Inc. (Nasdaq:BNVI - News), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that enrollment has started to the Phase 3 pivotal clinical trial evaluating the safety and efficacy of two doses of Menerbaâ„¢ (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.
The Phase 3, multicenter, double-blind, placebo-controlled, randomized clinical trial evaluating Menerba is currently open for enrollment. A total of 50 clinical sites in the U.S. will enroll 1,200 postmenopausal women between the ages of 40 and 65 years. Participants will be randomized to Menerba 5g/day, Menerba 10g/day or placebo and treated for 12 weeks. The primary aims of the study are to determine the safety and efficacy of two doses of Menerba compared to placebo after 12 weeks of treatment. Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment. Dr. Wulf Utian, Executive Director Emeritus and Honorary Founding President of the North America Menopause Society and Professor Emeritus at Case Western Reserve University is serving as the Principal Investigator for the study.
"We have had a very busy and productive year preparing for today's important launch of the late stage clinical trial in the field of women's health. As predicted from our vast toxicology data and the mechanism of action, we showed that higher doses of Menerba were very safe and demonstrated a level of efficacy similar to hormone therapy. Today we are proceeding with our first pivotal Phase 3 trial of Menerba with great optimism and enthusiasm. We are elated to be one step closer to providing a truly novel agent for the treatment of menopausal hot flashes to the 40 million women in need of this therapy," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer.
"This Phase 3 trial is one of two Phase 3 trials required by the FDA for approval," said Isaac Cohen, O.M.D., Chairman and Chief Executive Officer of Bionovo. "Menerba (MF101) has an enormous proven market and extraordinary market appeal due to its botanical origins and the safety and efficacy it demonstrated to date. We expect to have top-line data from this study in approximately 18 months."
About Menerba
Menerba is an oral drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause, which is manufactured from botanical sources. Menerba is an estrogen receptor beta (ER-b) selective drug, developed as an alternative to the products currently on the market which have been shown to increase the risk for breast and uterine cancers. It has been shown that the increased risk of breast and uterine cancers is associated with activation of estrogen receptor alpha (ER-a) and that activation of estrogen receptor beta (ER-b) blocks the growth promoting effects on breast cancer cells. The active ingredients in Menerba are derived from botanicals with centuries of recorded safe, effective use in traditional Chinese medicine (TCM). Bionovo recognizes the opportunity to commercialize a product that would be as effective as hormone therapy, without the health risks. Menerba has completed a Phase 2 trial with positive results for efficacy and has been evaluated by an independent Data and Safety Monitoring Board and passed through a standard two-round examination for safety. Menerba also has been shown in animal studies to prevent the proliferation of breast cancer and to have a beneficial effect on osteoporosis, though this has not yet been studied in humans.
Nice news - glad I picked up more by accident the other day. I meant to pick up another 5k CYCC but accidently had BNVI in trading window... Maybe it'll pan out for me!
Be careful - BE VERY CAREFUL
News released or ?? This thing taking OFF with some very nice buys
You can tell this is really a "Highly Demanded Stock". Bid now .30 and ask dropped to .65
Kinda depressed me with Steiner dumping continuously... Have tried not to pay attention to it too much but was did pick up more at .72 other day as it's finally starting to get some air
Nice volume and a positive direction
Remember - not even a year ago this was over $4 with little to cause the drop!
He's not doing anything... Tom is the one that killed the money!
I sold at .64 and looking to get back in if it goes below .60 again
Don't think anyone is buying now... Pump is OVER with and they're gone with their few dollars
I kinda feel bad for those that bought at .70 though, hopefully they can get out without losing what I've lost on Tom's stocks!
Nice upside volume this morning... Anyone know what's up?
Anyone hear from someone that went to this? If I wasn't 42000 hrs away (well, closer than that but do have to work due to scams such as those I've been played by)
Alteri's is not making ANY subs for JReck's so this below news is worthless
Tommy is currently trying to sue to get JRecks to buy from Alteri's again, but believe that's a longshot...
Considering the spring (2nd Quarter) is tourist season in North Country shouldn't they do more business in the 2nd Quarter?
How about results compared to 2nd Quarter last year? OOOOPS
Great big pump job going on here, feel really bad for those about to lose their money!
Apparently you didn't realize this... But he too is paid to PUMP HBWO like you are!
Tommy is back to the paid pumpers, at least now they have to disclaim it
Why does it not surprise me that Tom is compensating for "public awareness? ... AGAIN
WTF going on with L2 ? ask jumping like crazy between .57/.5795 with no trades. just back and forth!
Touched .60 this morning - can't wait for the end of the day today, bet we're at .65
CHURN BABY CHURN! Need today to hit almost 2 mil volume too!
ME thinks someone is looking for a quick pump and dump...
Everyone buckled up for the RIDE?
Message in reply to:
Enough to make a few bucks maybe...
There are many easier ways to make money, with a lot less risk
Nice PM action... 76k volume and moving UP
Creating sub companies within the company with like sounding names and announcing share buybacks and cancellations to that sub just to dilute...
Giving family generous CD's at marked up rates and pumping while they sell their shares...
Stating dilution expected to subside soon while simultaneously signing his name to 7 convertible debentures...
Moving items in and out of his multiple shells so often not even he knows what is supposed to be where...
Disposal of assets with 0 consideration to shareholders and/or shareholder knowledge of...
Going from OTCBB to pink stating 84 shareholders when in reality was thousands...
Filing false filings with the SEC and having to go back and re-write those filings due to lying about value of company he purchased from himself and sister...
What else ya need?
Nice news out this morning
Cyclacel Announces Data Safety Monitoring Board Recommendation to Continue the SEAMLESS...
Thu Oct 13, 2011 7:01am EDT
Cyclacel Announces Data Safety Monitoring Board Recommendation to Continue the
SEAMLESS Phase 3 Trial of Sapacitabine
BERKELEY HEIGHTS, N.J., Oct. 13, 2011 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company),
today announced that the independent Data Safety Monitoring Board (DSMB) of
SEAMLESS, the Phase 3, randomized, registration-directed study of sapacitabine
in elderly patients with acute myeloid leukemia (AML), recommended that the
study should enter the randomized stage as planned. The DSMB reviewed available
data from a total of 46 patients receiving oral sapacitabine capsules, the
Company's lead product candidate, administered in alternating cycles with
decitabine. The DSMB noted that no safety or efficacy concerns were identified.
The DSMB review was mandated in the Special Protocol Assessment (SPA) agreement
that Cyclacel entered into with the U.S. Food and Drug Administration (FDA) with
regard to the SEAMLESS study protocol.
"The DSMB's recommendation to continue our SEAMLESS Phase 3 study of
sapacitabine in patients aged 70 years or older who are not candidates for or
have refused intensive induction chemotherapy confirms that the treatment
regimen of administering sapacitabine in alternating cycles with decitabine is
safe and tolerable in the multicenter setting," said Judy H. Chiao, M.D., Vice
President, Clinical Development and Regulatory Affairs of Cyclacel. "The
objective of the randomized stage of the study is to establish the role of
sapacitabine in the front-line treatment of AML in this population with a high
unmet medical need," continued Dr. Chiao.
Of the 46 patients reviewed by the DSMB, 21 were enrolled in the lead-in stage
of SEAMLESS and 25 in an earlier pilot Phase 1/2 study using an identical
treatment regimen. Interim data from the Phase 1/2 study were presented at the
American Society of Clinical Oncology (ASCO) Annual Meeting in June 2011.
Lead-In Stage Topline Results
In accordance with the study protocol, 21 patients with previously untreated AML
aged 70 years or older who were not candidates for or have refused intensive
induction chemotherapy were enrolled. Patients who received hypomethylating
agents for prior myelodysplastic syndromes or myeloproliferative diseases were
excluded. Patients received intravenous decitabine at 20 mg/m2 per day for five
consecutive days of a 4-week cycle (odd cycles) and sequentially sapacitabine at
300 mg orally twice per day for three days per week for two weeks of a 4-week
cycle (even cycles).
The regimen is considered tolerable as the rate of dose-limiting toxicity was
9.5% and the 8-week mortality rate was 14.3%. The prespecified criteria as per
protocolwere: dose-limiting toxicity in less than 33% of patients and an 8-week
mortality rate of less than 37%. Eight-week mortality, or death rate, was
defined as death due to any cause occurring within 60 days after the date of
patient registration into the study.
Pilot Phase 1/2 Study Topline Results
Updated data from 25 patients treated with the identical regimen and at least 60
days of follow-up showed no dose-limiting toxicities and 8-week mortality rate
of 12.0%. The updated study results will be presented at a forthcoming major
medical conference.
About Acute Myeloid Leukemia (AML)
AML is a cancer of the blood cells that progresses rapidly and if not treated,
could be fatal in a few months. AML is generally a disease of older people and
is uncommon before the age of 40. The average age of a patient with AML is about
67 years. There are more than 12,300 new cases of AML, of which about half are
elderly. Nearly 9,000 deaths are caused by this cancer each year in the United
States. A recently published review of The University of Texas MD Anderson
Cancer Center's historical experience with front-line intensive induction
chemotherapy for AML patients aged 70 years or older, excluding patients with
favorable karyotypes, demonstrated that while 45% achieved a complete remission,
median overall survival was only 4.6 months and was associated with a 4-week
death rate of 26% and a 8-week death rate of 36% (Kantarjian, H, et al, Blood,
DOI 10.1182/blood-2010-03-276485).
About sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently
being evaluated in a registration-directed, Phase 3 trial in front-line elderly
acute myeloid leukemia (AML) and Phase 2 trials in patients with hematological
malignancies and solid tumors. Sapacitabine acts through a dual mechanism,
interfering with DNA synthesis by causing single-strand DNA breaks and inducing
arrest of cell cycle progression mainly at G2-Phase. Both sapacitabine and
CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in
preclinical studies. Over 300 patients have received sapacitabine in Phase 2
studies in AML, myelodysplastic syndromes (MDS), cutaneous T cell lymphoma
(CTCL) and non-small cell lung cancer (NSCLC). Sapacitabine has been
administered to approximately 170 patients in five Phase 1 studies with both
hematological malignancies and solid tumors. In June 2009 at the Annual Meeting
of the American Society of Hematology (ASH), Cyclacel reported data from a
randomized Phase 2 study single agent study of sapacitabine including promising
1-year survival in elderly patients with AML aged 70 years or older. In June
2011 at the Annual Meeting of the American Society of Clinical Oncology (ASCO),
Cyclacel reported data from a pilot Phase 1/2 study including promising 8-week
mortality in elderly patients with AML aged 70 years or older receiving
sapacitabine alternating with decitabine. The U.S. FDA and the European
Medicines Agency have designated sapacitabine as an orphan drug for the
treatment of both AML and MDS. Sapacitabine is part of Cyclacel's pipeline of
small molecule drugs designed to target and stop uncontrolled cell division.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target
the various phases of cell cycle control for the treatment of cancer and other
serious diseases. Sapacitabine (CYC682), an orally-available, cell cycle
modulating, nucleoside analogue, is in Phase 3 development for the front-line
treatment of acute myeloid leukemia in the elderly and Phase 2 studies for
myelodysplastic syndromes, lung cancer and chronic lymphocytic leukemia.
Seliciclib (CYC202 or R-roscovitine), an orally-available, CDK (cyclin dependent
kinase) inhibitor, is in Phase 2 studies for the treatment of lung cancer and
nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine.
Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S.
Xclair(R) Cream for radiation dermatitis, Numoisyn(R) Liquid and Numoisyn(R)
Lozenges for xerostomia. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based on a
portfolio of commercial products and a development pipeline of novel drug
candidates. Please visit www.cyclacel.com for additional information.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks
and uncertainties that could cause actual results to be materially different
from historical results or from any future results expressed or implied by such
forward-looking statements. Such forward-looking statements include statements
regarding, among other things, the efficacy, safety, and intended utilization of
Cyclacel's product candidates, the conduct and results of future clinical
trials, plans regarding regulatory filings, future research and clinical trials
and plans regarding partnering activities. Factors that may cause actual results
to differ materially include the risk that product candidates that appeared
promising in early research and clinical trials do not demonstrate safety and/or
efficacy in larger-scale or later clinical trials, trials may have difficulty
enrolling, Cyclacel may not obtain approval to market its products, the risks
associated with reliance on outside financing to meet capital requirements, and
the risks associated with reliance on collaborative partners for further
clinical trials, development and commercialization of product candidates. You
are urged to consider statements that include the words "may," "will," "would,"
"could," "should," "believes," "estimates," "projects," "potential," "expects,"
"plans," "anticipates," "intends," "continues," "forecast," "designed," "goal,"
or the negative of those words or other comparable words to be uncertain and
forward-looking. For a further list and description of the risks and
uncertainties the Company faces, please refer to our most recent Annual Report
on Form 10-K and other periodic and current filings that have been filed with
the Securities and Exchange Commission and are available at www.sec.gov. Such
forward-looking statements are current only as of the date they are made, and we
assume no obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
(C) Copyright 2011 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel Pharmaceuticals, Inc.
Numoisyn(R) and Xclair(R) are trademarks of Sinclair Pharma plc.
CONTACT: Investors/Media:
Corey Sohmer
(908) 517-7330
csohmer@cyclacel.com
Someone would have to be a damn good pumper to get anything moving in here. Not only fighting the billions in dilution already out, but also the dilution yet to come!
Good luck
Message in reply to:
IHUB ADMIN: can you take me off as assistant on this stupid board? Someone put me on without my consent or knowledge.
LOL... I'd say someone found a way to get some of 1541 people to take a look at this board :)
Couple very big buys at 1.03 - 80k and 25k. Looks like it's gonna continue to rise or someone throwing away a lot of money!
Looking very good! Long way to go before we start hitting heavy resistance levels
http://finance.yahoo.com/news/Diabetes-Cancer-Treatment-iw-1959824401.html?x=0
Diabetes and Cancer Treatment Becoming Most Lucrative Path for Biotech Industry
The Bedford Report Provides Equity Research on Dendreon and Biodel
Companies:
Biodel Inc.
Dendreon Corporation
BIOD
0.61
+0.05
Press Release Source: The Bedford Report On Tuesday October 4, 2011, 8:16 am EDT
NEW YORK, NY--(Marketwire -10/04/11)- In recent years the FDA has been heavily scrutinized for making the approval process more difficult for drug developers. A ground breaking study released this year by the BIO and BioMedTracker finds that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is a mere ten percent. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides equity research on Dendreon Corporation (NASDAQ: DNDN - News) and Biodel, Inc. (NASDAQ: BIOD - News). Access to the full company reports can be found at:
www.bedfordreport.com/DNDN
www.bedfordreport.com/BIOD
Previously the rate of approval was one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development.
Janet Woodcock, the head of the FDA's drug division, is quick to dismiss concerns regarding the FDA's approval process. This summer in testimony before the House Energy and Commerce's health subcommittee, Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications.
The Bedford Report releases investment research on the Apparel Retail Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Dendreon's Provenge is a therapy designed to train a patient's immune system to fight prostate cancer. Studies indicate it extended patients' lives by about four months. Recently the FDA approved a third facility where the company will make Provenge.
Biodel Inc., a development stage biopharmaceutical company, focuses on the development and commercialization of treatments for diabetes. It develops its product candidates by applying its proprietary formulation technologies to existing drugs. According to Frost & Sullivan research titled "US Diabetes Drug Delivery -- Patient Perspective," the future of diabetes treatments is in the convenient drug delivery methods. Type-1 diabetic patients are most likely to prefer a twice-a-day oral dosing regimen, while type-2 diabetic patients are also expected to prefer a twice-a-day oral dosing regimen or a twice-a-day patch.
The Bedford Report provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer
88% off 52 wk high
15% off 52 wk low
27% institution & insiders
Market cap only $21 million???
Jeez... they are really trying to beat this one down!
Watch what you ask for... He will probably soon announce buyback/cancellation of 90% of shares for Empire Pizza Holdings Co, Inc (newly created sub of EMPZ - in Scozzafava fashion) and all of the while dumping on people that think this will finally get out of the gutter
Actually I don't think he's a SH anymore (and hasn't been for a while) so his backing has strictly to do with honest feelings...
I do back him on this! What he feels is honest (he stated long ago he sold out and he stated this)
Why you're at it why not find out what ASSETS they absorbed due to Wamu
If I remember correctly... Wamu's performed better than anyone thought and during the BS fiasco there was complaints about JPM putting some of their non-performing mortgage portfolio in there - maybe I am wrong, but I believe it was stated this happened
JPM even stated Wamu's loans were much better than expected!
Hmmm... I show 1500 purchased premarket at .80 ???
The deal then was JP Morgan put $1 billion into Maiden Lane, the Fed put $29 billion in cash into it. Maiden Lane paid Bear Stearns $30 billion, which went straight back to JP Morgan as this deal happened simultaneously to JP's purchase of Bear. So Morgan got $30 billion in cash ($29 billion net) and the Fed got stuck owning the crap, but was legally only making a loan to Maiden Lane, who was the legal owner. By the Fed's own accounting - which is very different from a real company's accounting - Maiden Lane has lost $5 billion between its creation and today.
So yes, JPM should be doing pretty well - $29 billion free dollars. I'd have bought Bear Stearns too had the FED given me $29 billion for all the junk in it
Picked shares back up this am... Ready to go!
You really believe that JPM has been a fairly clean bank? They're being sued right and left of pushing CDS on municipalities and causing those very municipalities to go broke. You can say the municipalities shouldn't have borrowed more than they could repay, but at the same time there was a reason these banks were pushing these "Oh, you can save money using this and pay for it later - obviously it was for the banks or they wouldn't have pushed so many into them.
Not to mention how many times did the FED buy up JPM's junk mortgages? Maiden Lane ring a bell? And Mr Dimon has nothing to do with the FED, right?