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Thanks again K, I bumped up stops earlier
Started picking some of this up off Feb's reversals, plenty of cu$hion.
CYTX nice move but now bumpin its head @50dma, also lots of VAP@ $6
DNDN ramping all morning
MNKD on news...
MannKind says Afrezza safe and effective in trials
10:00 am ET 04/23/2010- Reuters
* Glucose control similar to standard insulin
* Small differences in lung function observed
* Lung changes disappeared 3 mos after stopping Afrezza
LOS ANGELES, April 23 (Reuters) - MannKind Corp <MNKD.O> said on Friday data shows that its experimental inhaled insulin device, Afrezza, controls blood sugar levels in patients with diabetes without meaningful, long-term changes in lung function.
The company has filed for U.S. Food and Drug Administration approval of Afrezza, which is designed to deliver a more effective rapid-acting insulin than injectable products. The FDA said in March that it needed more information on the MannKind drug device before it could complete its review.
Results from two Phase III studies of Afrezza were presented in Boston at a meeting of the American Association of Clinical Endocrinologists.
MannKind said a two-year trial in patients with Type 1, also known as juvenile, diabetes found that Afrezza provided glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia.
After two years, levels of HbA1c, a common measure of blood sugar, were down 0.29 percent in the Afrezza group and 0.31 percent in the group receiving usual care. Afrezza resulted in average weight loss of 0.59 kilogram vs. weight gain of 1.38 kg for patients on standard care.
The incidence of hypoglycemic events in the Afrezza group was 61.8 percent, compared with 66.05 percent for the usual care group. There were 2.36 severe events per 100 subject-months in the Afrezza group compared with 3.76 for the usual diabetes care group.
Another 649-patient study looking at follow-up safety data suggests "that the pattern and magnitude of changes in lung function associated with the use of Afrezza in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful," the company said in a statement.
The findings were based on changes in pulmonary function after patients stopped use of Afrezza and resumed usual treatment.
Adults with diabetes who participated in any of four clinical trials of Afrezza were invited to participate in the safety trial, which followed them for up to three months. Lung function was assessed at the end of the parent trial and one and three months after completion of the parent trial.
During the original trials, "small, nonprogressive differences" in forced expiratory volume in one second and carbon monoxide diffusing capacity were observed in the Afrezza group.
MannKind said the changes disappeared, regardless of the duration of exposure to Afrezza, when the groups were compared three months after patients resumed usual therapy.
In the United States, about 11 percent of adults have diabetes. Most have Type 2 diabetes, the kind closely linked to obesity. Type 1 diabetes is an autoimmune disease in which the body mistakenly destroys the cells in the pancreas that make insulin.
Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels. Without proper levels of the hormone, the body becomes unable to break down and use sugar. If untreated, blood vessels and nerves are destroyed, organs fail and patients can die. (Reporting by Deena Beasley, editing by Matthew Lewis)
MKND on news...
MannKind says Afrezza safe and effective in trials
10:00 am ET 04/23/2010- Reuters
* Glucose control similar to standard insulin
* Small differences in lung function observed
* Lung changes disappeared 3 mos after stopping Afrezza
LOS ANGELES, April 23 (Reuters) - MannKind Corp <MNKD.O> said on Friday data shows that its experimental inhaled insulin device, Afrezza, controls blood sugar levels in patients with diabetes without meaningful, long-term changes in lung function.
The company has filed for U.S. Food and Drug Administration approval of Afrezza, which is designed to deliver a more effective rapid-acting insulin than injectable products. The FDA said in March that it needed more information on the MannKind drug device before it could complete its review.
Results from two Phase III studies of Afrezza were presented in Boston at a meeting of the American Association of Clinical Endocrinologists.
MannKind said a two-year trial in patients with Type 1, also known as juvenile, diabetes found that Afrezza provided glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia.
After two years, levels of HbA1c, a common measure of blood sugar, were down 0.29 percent in the Afrezza group and 0.31 percent in the group receiving usual care. Afrezza resulted in average weight loss of 0.59 kilogram vs. weight gain of 1.38 kg for patients on standard care.
The incidence of hypoglycemic events in the Afrezza group was 61.8 percent, compared with 66.05 percent for the usual care group. There were 2.36 severe events per 100 subject-months in the Afrezza group compared with 3.76 for the usual diabetes care group.
Another 649-patient study looking at follow-up safety data suggests "that the pattern and magnitude of changes in lung function associated with the use of Afrezza in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful," the company said in a statement.
The findings were based on changes in pulmonary function after patients stopped use of Afrezza and resumed usual treatment.
Adults with diabetes who participated in any of four clinical trials of Afrezza were invited to participate in the safety trial, which followed them for up to three months. Lung function was assessed at the end of the parent trial and one and three months after completion of the parent trial.
During the original trials, "small, nonprogressive differences" in forced expiratory volume in one second and carbon monoxide diffusing capacity were observed in the Afrezza group.
MannKind said the changes disappeared, regardless of the duration of exposure to Afrezza, when the groups were compared three months after patients resumed usual therapy.
In the United States, about 11 percent of adults have diabetes. Most have Type 2 diabetes, the kind closely linked to obesity. Type 1 diabetes is an autoimmune disease in which the body mistakenly destroys the cells in the pancreas that make insulin.
Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels. Without proper levels of the hormone, the body becomes unable to break down and use sugar. If untreated, blood vessels and nerves are destroyed, organs fail and patients can die. (Reporting by Deena Beasley, editing by Matthew Lewis)
K, Thanks! thats awsome. I didn't check out the situation in that manner. btw NVAX is having a nice premarket
And when anyone grazing through here stops to take the time to check out all the tools, resources and info in this ibox they'll be hooked like me. Well done to the WU.
Nice DD on SNSS here...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=49217134
w/ 400M shares out already??
BTW, Pam Shaw obviously never owned a boat
boat owners need a material world to make $$ cuz owning a boat is like standing in a cold shower tearing up $5,$10,$20's as fast as you can, lol
cccpmd and board - Flu Season Question...
I've been occasionally reviewing charts of those co.'s related to the H1N1 and recently bot NVAX for example based on the premis that over the last 3-4 yrs those shares commence their moves in March/April going into the upcoming flu seasons. I'll be the last to profess to being the 1st w/ this thought, I would be curious what your Seasonality outlook or comments are wrt same.
tia and glta
S
Chart, et al, H1n1 Seasonality question...
I've been occasionally reviewing charts of those co.'s related to the H1N1 and recently bot NVAX for example based on the premis that over the last 3-4 yrs those shares commence their moves in March/April going into the upcoming flu seasons. I'll be the last to profess to being the 1st w/ this thought, I would be curious what your Seasonality outlook or comments are wrt same.
tia and glta
S
IMMU - Immunomedics Reports New Blood Test for Detecting Early Stage Pancreatic Cancer Correlates With Response to Clivatuzumab Tetraxetan Treatment
Press Release Source: Immunomedics, Inc. On Tuesday April 20, 2010, 2:00 pm
•Sensitivity for Detection of a Partial Response (PR) was 100% with a 68% Specificity
•Preclinical Results of Combining Clivatuzumab Tetraxetan and Antibody-Drug Conjugate also Reported
WASHINGTON, April 20, 2010 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU - News), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported that a new blood test using the Company's proprietary humanized antibody, clivatuzumab or PAM4, predicted a partial response in an initial set of patients treated with a combination of the antibody labeled with yttrium-90 (Y-90) and gemcitabine. Results were presented at the 101st Annual Meeting of the American Association for Cancer Research.
"We have now demonstrated that the blood assay for PAM4-protein can not only detect early-stage pancreatic cancer, as has recently been reported by us, but may also predict a lack of response to therapy or an early relapse," remarked Cynthia L. Sullivan, President and CEO. "As a result, we believe we may be one step closer to offering an individualized approach for the management of this lethal disease," Ms. Sullivan added.
The challenge in pancreatic cancer is early diagnosis, before the disease has spread and treatment options become limited. To that end, the Company has recently developed a new serum-based enzyme immunoassay (ELISA) employing clivatuzumab that has a sensitivity of 62% for detecting stage-1 pancreatic cancer (disease confined to pancreas), 86% for stage 2 disease, and 91% for stage 3/4 (local and distant spread) cancers. (Please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR01212010.pdf for details of these results). Using the same ELISA test, the current study examined changes in PAM4-protein level in the serum of patients treated with Y90-clivatuzumab, as a means to predict a partial response.
At the recent 2010 ASCO-GI Symposium, the Company reported an overall response rate of 68% with 5 patients having a partial response (PR), 10 with stable disease (SD) and 7 with progressive disease (POD). (For more information on the Phase I/II studies of clivatuzumab as a treatment for patients with pancreatic cancer, please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR01252010.pdf). From this initial group of 22 patients, 17 were evaluable as having both baseline and follow-up sera available for PAM4 testing, of which 4 were PR, 11 patients with SD and 2 patients with POD. Notably, 1 patient was negative for PAM4 in the circulation and excluded from the evaluation.
The PAM4 ELISA correctly predicted 4 of 4 PRs. Four of 9 patients with SD were also predicted to have had a PR rather than an SD. However, it is noted that one of these SD patients had a 29% decrease in tumor size which is just under the 30% criteria under RECIST to qualify as a PR. Overall, the sensitivity for detection of a PR was 100% with a specificity of 68%. Importantly, neither of the patients with POD was falsely recognized as PR.
"Although these results are based on a small number of patients, the trend encourages us to expand such studies to evaluate whether this new bioassay for pancreatic cancer continues to be predictive of response to diverse therapies," Ms. Sullivan commented further.
Separately, in a study to be reported later in this conference, the effects of adding an antibody-drug conjugate that targets pancreatic cancer (hRS7-SN-38) to Y-90 labeled Clivatuzumab tetraxetan were investigated in a mouse model of human pancreatic cancer. Results showed that the combination produced more robust objective response than each agent alone. In particular, all animals receiving Y90-clivatuzumab at the maximum tolerated dose and hRS7-SN-38 achieved a tumor-free state within 4 weeks, while other animals continued to have evidence of persistent disease. These studies provide the first evidence that combined radioimmunotherapy and antibody-drug conjugate can enhance efficacy at safe doses.
About Clivatuzumab
Clivatuzumab or hPAM4 is a humanized monoclonal antibody targeting a mucin antigen expressed in most pancreatic cancers, but not pancreatitis, normal pancreas or most other normal tissues. Preclinical studies in mice with human pancreatic cancer xenografts given the murine version of Y-90 PAM4 demonstrated favorable tumor responses, which could be further improved when given in combination with gemcitabine. A prior Phase I single dose-escalation study of Y-90 clivatuzumab tetraxetan in treatment-relapsed pancreatic cancer patients has also produced encouraging results, with evidence of objective responses. The radiolabeled humanized antibody is currently in a Phase I/II fractionated dose-escalation study in combination with gemcitabine for the treatment of patients with newly diagnosed, untreated, stage III or stage IV cancer of the pancreas.
About Pancreatic Cancer
According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death in the United States. In 2009, an estimated 42,470 Americans were diagnosed with the disease, and about 35,240 patients died from it. It is often called a silent disease because it is difficult to detect and symptoms do not usually appear until the cancer has grown and often spread beyond the pancreas for quite some time. Pancreatic cancer is difficult to diagnose because there are no symptoms in the early stages and because, when symptoms appear, they can be confused with other diseases.
The treatment options depend on stage and location of the cancer, age, and general health of the patient. Potentially curative surgeries are performed when the cancer has started in the head of the pancreas (near the bile duct), which can allow earlier detection when bile duct blockage produces jaundice. Palliative surgery is a type of surgery chosen when the tumor is too widespread and is done to relieve the symptoms or complications caused by the cancer. If the cancer has not spread beyond the pancreas, therapy can be successful, but it is rare to find pancreatic cancer in the early stages. In later stages, various forms of chemotherapy or combinations of radiation and chemotherapy are given to try to control the disease, and ultimately therapy strives to comfort the patient and reduce pain.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 148 patents issued in the United States and more than 300 other patents issued worldwide, protects our product candidates and technologies. For additional information on us, please visit our website at http://www.immunomedics.com/. The information on our website does not, however, form a part of this press release.
SLXP - T.Weisel starts coverage $52 tgt
SLXP - T.Weisel starts coverage $52 tgt
KERX nice pm, getting added attention @ SeekingAlpha
http://seekingalpha.com/article/198045-keryx-biopharmaceuticals-could-easily-triple-within-the-next-year?source=hp_mostpopular
KERX nice pm, getting added attention @ SeekingAlpha
http://seekingalpha.com/article/198045-keryx-biopharmaceuticals-could-easily-triple-within-the-next-year?source=hp_mostpopular
ATHX: Initiated - JAGNote by Brean Murray
8:31 AM ET - JAG Media
ATHX: Initiated - The firm initiated coverage of the shares with a Buy rating and price target of $8.
ATHX: Initiated - JAGNote by Brean Murray
8:31 AM ET - JAG Media
ATHX: Initiated - The firm initiated coverage of the shares with a Buy rating and price target of $8.
NVAX ppl? comments? TIA
CPKI fires lit @ close w/ .5M shares
CPKI Someone lit a fire under it w/ 1/2M shares at close...hmmm
SCLN bumping its head on hod, nice final hour
SCLN bumping head on it's hod, nice final hour
$heff $tation -
I've been monitoring the board and want to compliment everyone on it's success. I'm getting back into trading after a "real job" hyatis because there's nothing else like this except steering a ship thru a storm for all that goes w/ doing it right. I know I've got a steep learning curve ahead to do this right and appreciate this site for all its ibox tools, members, and the way everyone interacts.
Im looking forward to contributing and making $$$!
Thanks
SCLN trying to breakout > $4.25 on heal of this morns upgrade and $7.25 price tgt
SCLN trying to breakout >$4.25 on heals of this am upgrade and $7.25 $tgt
DCTH the energizer bunny...
Delcath Systems (DCTH) option prices elevated into data
8:50 am ET 04/09/2010 - StreetInsider
Delcath Systems (Nasdaq: DCTH) is recently up 15c to $9.62 in pre-open trading. DCTH is expected to release in early April late-stage data from its recently completed Phase three trial of melphalan using the PHP System (Percutaneous Hepatic Perfusion), technology that allows physicians to deliver higher doses of existing chemotherapy drugs to the liver without exposing the entire patient's body to the anti-cancer drugs. Key secondary data as survivability will likely not be presented at this time. April 10 straddle is priced at $2.45, May 10 is at $4.50, and June 10 is at $5.20 according to Track Data suggesting large price movement.
Amylin Pharmaceuticals (AMLN) Falls on Byetta Cancer Risk Memo
8:59 AM ET - StreetInsider
Amylin Pharmaceuticals, Inc. falls on headlines Byetta may have veiled cancer risk.
Amylin Pharmaceuticals (AMLN) Falls on Byetta Cancer Risk Memo
8:59 AM ET - StreetInsider
Amylin Pharmaceuticals, Inc. falls on headlines Byetta may have veiled cancer risk.
Amylin Pharmaceuticals (AMLN) Falls on Byetta Cancer Risk Memo
8:59 AM ET - StreetInsider
Amylin Pharmaceuticals, Inc. falls on headlines Byetta may have veiled cancer risk.
Amylin Pharmaceuticals (AMLN) Falls on Byetta Cancer Risk Memo
8:59 AM ET - StreetInsider
Amylin Pharmaceuticals, Inc. falls on headlines Byetta may have veiled cancer risk.
Guess they don't make as much advising patients to get out of their lazy-boyz, put down the pork rinds and doing some abdominal exercises, lol.
AMLN fell out of bed, news? Sure bounced quickly, hmm
Heck of a bounce, too. Someone ran it straight down to the 50sma. hmm
AMLN falling out of bed, news?
AMLN falling out of bed, news?
AMLN falling out of bed, news?
SCLN - upgrade and $7.25 tgt
BWS Financial Upgrades SciClone Pharmaceuticals (SCLN) to Buy
8:17 am ET 04/09/2010- StreetInsider
BWS Financial upgrades Sciclone Pharmaceuticals (Nasdaq: SCLN) from Hold to Buy with a new $7.25 price target.
The firm said, ..."to aid the growth of ZADAXIN, has been steadily adding to its sales force in China. It is becoming apparent that the Company has been gaining good traction with their product in China."
not familiar w/ BWS here but SCLN could get interesting w/ first speedbump @ $4.25
SCLN - upgrade and $7.25 tgt
BWS Financial Upgrades SciClone Pharmaceuticals (SCLN) to Buy
8:17 am ET 04/09/2010- StreetInsider
BWS Financial upgrades Sciclone Pharmaceuticals (Nasdaq: SCLN) from Hold to Buy with a new $7.25 price target.
The firm said, ..."to aid the growth of ZADAXIN, has been steadily adding to its sales force in China. It is becoming apparent that the Company has been gaining good traction with their product in China."
not familiar w/ BWS here but SCLN could get interesting w/ first speedbump @ $4.25