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"Special - K" and Depression
Maybe we should let Carr and the rest of the gang know there may be other legal uses for ketamine other than pain management.
http://www.newsdaily.com/stories/l02842132-depression-ketamine/
and
http://www.sciencedaily.com/releases/2006/08/060808091257.htm
Merck Serono and ZymoGenetics Initiate Atacicept Phase 2 Clinical Trial in Relapsing Multiple Sclerosis
Wednesday April 30, 6:00 am ET
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), today announced that its development partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has initiated a Phase 2 clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).
“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”
The four-arm randomized, double blind, placebo controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.
Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will have follow-up visits at 48 weeks.
About Relapsing Multiple Sclerosis (RMS)
Multiple sclerosis (MS) is a disease of the central nervous system that can lead to permanent damage of the nerves in the brain and spinal cord. Patients with RMS may experience an attack or series of attacks followed by a complete or partial remission. Permanent disability may be accrued by incomplete recovery from relapses and by neurodegenerative processes, which are more prominent in the later stages of the disease. RMS is the most common form of MS. According to the National MS Society, approximately 400,000 people in the U.S. have MS, and every week about 200 people are diagnosed; worldwide, 2.5 million individuals may have MS.
About Atacicept
Merck Serono and ZymoGenetics are developing atacicept (formerly referred to as TACI-Ig) as a potential treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis and multiple sclerosis, as well as B-cell malignancies.
Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as systemic lupus erythematosus. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, lupus erythematosus, B-cell malignancies and multiple sclerosis. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.
http://biz.yahoo.com/bw/080430/20080430005019.html?.v=1
"If the welfare of cancer patients were the main issue, wouldn’t you want DNDN to wait for another 56 events (360-204) in order to give the trial the best possible chance to succeed?
From a patient-advocacy standpoint, surely the delay in obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."
You describe my nightmare - I wish they would have left the trial alone and waited for those hopefully 56 high HR events. Obtaining financing certainly those not seem to be a problem for them. Waiting another 6 to 12 months would not have been such a big deal since the trial has already been going on for nearly 5 years.
Thanks Ocyan - I was just looking to see if you concur that if 9902b achieves a HR of roughly 1.3 at the final, as postulated by P3analyze on IV, it should be a success? A 1.3 HR ain't bad. I worry because with roughly 60% patients at the interim, and 40% at the final with less than 24 months from randomization - this group could really hurt overall HR with maybe an HR of 1.1 based on looking at 9901/9902a. This leaves the remaining 40% or 60% later enrolled patients to carry the day - and they would need an HR roughly over 1.7 (and that is 0.2 higher than the integrated) to bring the study to roughly the 1.4 level, if that's enough to meet p-value requirements? Do the later enrollees worry you? Thanks
Ocyan - do you have any thoughts on the minimum hazard ratios (if such a calculation is even possible) requiried to meet statistical significance I asked over on IV today (assuming I guess roughly 0.02 alpha and 220 to 240 patients at the interim and alpha of 0.04 at the final)? I am just trying to get a handle on what the HR hurdles required for success are at each look at the data. Much appreciation as always.
Medchal
My Uncle has PC and is being treated by Dr. Berger, one of Provenge's principal investigators. Dr. Berger, a caring and knowledgeable oncologist, believes Provenge works and could make a real contribution to PC care. My Uncle is WWII Marine who fought on the beaches of Saipan and Tinian for this country. It would have nice to have Provenge as a potential treatment option for him. If you want to see someone who is "animalistic", "rabidly self-righteous" and "disingenuous" look in the mirror.
Surf - thanks interesting.
Wish we knew the royalty JAV pays Shimoda and what ABII will pay on milestones, but at least someone sees some value for Dyloject.
CEGE Partners Worldwide
http://biz.yahoo.com/bw/080331/20080331006422.html?.v=1
OT: Great, sounds like you had a good time (eom).
OT – Welcome back Wall. Any particularly high adrenalin dives? I would love to learn, but fear I would have major problems equalizing my ears. I will definitely give it a try one day however.
Ranch. Did you find it interesting that when the EG Edwards analyst asked about the CMC issue somehow the call was disconnected without a reply? The analyst was on a speaker phone that caused an echo. Gold asked him to take it off speaker and the call dropped. Difficult to tell if Gold hung up or the analyst hit the wrong button and accidently disconnected.
Trial Power v. Treatment Effect
In trying to estimate the likely success of 9902B, the far more important variable to consider is the likely observed treatment effect demonstrated by the trial as designed (HR) rather than some modest increase or decrease in power. Our collective brain power would be far better utilized on that effort than on a modest change in power discussion. Does the trial as designed capture the likely strong treatment effect as evidenced in prior trials for perhaps the 20% to 30% of the treated cohort that benefit most from Provenge? Will this effect be somehow lost or diminished in 9902B as designed? Will enough of the high HR events be captured in the statistical analysis for the trial to be a success? In my view, these are the most important questions to discuss. All the rest is relatively minor.
More quotes from Pazdur showing what a heartless hypocrite he is.
POWERFUL MEDICINE
FDA Cancer Czar Stirs Debate On Agency's Role Anemia-Drug Tussle
Puts Pazdur on Spot; Father's Early Death
By ANNA WILDE MATHEWS
March 12, 2008; Page A1
Over two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. The doctor says he declined, because he believed further treatment wouldn't help. The patient died less than an hour later.
Dr. Pazdur, 55 years old, still makes life-or-death judgments. But now, each one affects millions of Americans. As head of the Food and Drug Administration office that regulates oncology drugs, Dr. Pazdur is the gatekeeper for any new cancer medicine that goes on the U.S. market -- and an estimated 30% of all drugs that are in an advanced stage of development.
Companies and some patient advocates complain that Dr. Pazdur's decisions and his rigorous standards of evidence have kept drugs from cancer sufferers who sometimes have no other hope. Drug makers say that approaches like Dr. Pazdur's slow the development and approval of new products.
Last fall, dozens of protestors gathered outside the FDA's headquarters to complain about the agency's handling of cancer medicines. Two prostate-cancer patients blamed the agency for rejecting a treatment they said helped keep them alive. Later, the group broke into a chant: "Pazdur Must Go! Pazdur Must Go!"
On the other side, cancer researchers and other patient groups say Dr. Pazdur approves drugs that work and provides a bulwark against those that are unproven and potentially dangerous.
Dr. Pazdur's role crystallizes broader questions about the FDA itself. Amid rapid changes in medical science and soaring health-care costs, Dr. Pazdur and the agency face conflicting pressures. Some want the FDA to make it easier for cancer patients and doctors to get access to drugs, by relaxing traditional standards for measuring their benefits. Others want the FDA to set a high bar to protect Americans from drugs with only limited effectiveness.
Around 1.4 million cases of cancer are expected to be diagnosed in 2008, and 565,650 Americans are expected to die of cancer this year. Still, better detection and better treatments have steadily improved the odds for many patients. For people diagnosed between 1996 and 2003, the five-year survival rate was 66%, up from 50% for those diagnosed between 1975 and 1977.
'Toxic Placebo'
Dr. Pazdur emphasizes the importance of statistical tests over the often compelling stories of individual cancer patients. "We can't be put in the position of approving a toxic placebo," he says.
But just last month, the FDA surprised some critics by granting permission for Genentech Inc. to market the drug Avastin for breast cancer; the drug helped slow the progression of the disease, even though it hadn't been shown to extend patients' lives, a measure traditionally considered a "gold standard" for cancer-drug approvals. In interviews, Dr. Pazdur, whose office reviewed Avastin, called the decision an example of regulatory "flexibility."
Patients' Paintings
The son of working-class parents, Dr. Pazdur grew up in Calumet City, Ill., south of Chicago. His views have been shaped by the years he and his wife, Mary, an oncology nurse, have spent treating cancer patients, he says. His grandmother died of breast cancer. Two uncles and an aunt were killed by forms of the disease.
But he also watched his father -- who went blind when Dr. Pazdur was a teen and suffered from diabetes and pulmonary fibrosis -- endure the side effects of steroid drugs that didn't help his condition.
"There's a heightened awareness I have that drugs can cause harm, and that's why we do need evidence drugs work," Dr. Pazdur says. "These drugs hastened his death." He says he thinks every day of his father, who died in 1979.
The walls of Dr. Pazdur's suburban town house display paintings given to him by patients, and he can recall names and treatment details of people he cared for decades earlier. Doctors who trained under him say he was gentle but never sugarcoated grim news. He was careful to meet patients' eyes and often used the phrase, "You need to come to terms with your disease."
He says, though, that he doesn't become friends with patients, or even allow them to use his first name. In the case of the patient who grabbed his coat, the man's cancer hadn't been stopped by standard chemotherapy or an experimental treatment.
"What do you tell somebody?" Dr. Pazdur says. "He was just unwilling to accept the inevitable."
A Drug Denied
Dr. Pazdur got his first real experience with the FDA when a chemotherapy drug known as UFT, backed by Bristol-Myers Squibb Co., came up for market review at the agency. Dr. Pazdur, who had risen through the ranks to a post as a professor of medicine at the University of Texas M.D. Anderson Cancer Center, oversaw the main trial of the drug.
One of his colon-cancer patients, Larry Daspit, had a remarkable response to UFT: The disease, which had spread to his lymph nodes and liver, apparently vanished. Still, Mr. Daspit recalls, even after he began to show improvement, Dr. Pazdur would warn him, "do not think this means you are cured," seeking to avoid giving him false hope.
The FDA didn't approve UFT. Mr. Daspit says he was surprised and upset by the decision, issued in 2001. "Why deny people that choice?" he asks. Dr. Pazdur, who was at the FDA by then, recused himself from the decision.
Dr. Pazdur says that when he met with agency officials about UFT, he was struck by "the influence that the FDA had on the entire development of drugs." He was ready to try something new, he says, so when the position overseeing the agency's oncology drug-review division came open, he applied and won it in 1999.
He quickly began reaching out to major interest groups, with the goal, he says, of opening up lines of communication. "He stepped into the role and approached us," says Ellen Stovall, chief executive of the National Coalition for Cancer Survivorship. It was also a politically savvy move: Ms. Stovall's group and others have been strong supporters during Dr. Pazdur's rise at the FDA. In 2005, he was promoted to head a new, more powerful office overseeing all cancer drugs. His original post didn't include oversight of biotech treatments.
Dr. Pazdur now oversees around 125 people, including oncologists, pharmacologists and hematologists. He says verdicts on drugs are driven by consensus among agency reviewers, as well as FDA standards. "We make the decisions on what we believe is the best science," he says. "This is not an issue of personality. It is an issue of looking at the data."
'The Decider'
Patricia Keegan, who oversees the biotech-drugs division under Dr. Pazdur, says he is "very open to listening to all sides before he makes a decision," but for new drug approvals, he is "the last person to weigh in, the decider."
Dr. Pazdur has had run-ins with higher-level FDA officials. Early last year, amid safety questions about the anemia drugs made by Johnson & Johnson and Amgen, Dr. Pazdur told the companies they should stop promoting the products. Johnson & Johnson says its lawyer contacted the FDA's chief counsel, a Bush administration appointee named Sheldon Bradshaw, about Dr. Pazdur's directive.
After that, Mr. Bradshaw told Dr. Pazdur that such an order would infringe on the companies' free-speech rights, according to a person with knowledge of the matter. Dr. Pazdur then "clarified" that the FDA was only requesting a voluntary halt, according to an account that Johnson & Johnson provided to Congress. A congressional committee opened an investigation into promotion of the anemia drugs in March 2007.
Amgen declined to comment. Johnson & Johnson says, "It is important to preserve [the company's] ability to communicate with health-care providers and patients, particularly when there is important new safety information about its products."
Under Scrutiny
As Dr. Pazdur's power has grown, his words and actions are parsed with some of the same intensity as Federal Reserve chief Ben Bernanke's.
Old friends say he won't let them pick up the check at dinner, because they may research a drug that could come under FDA review. The job is hard to get away from: Mary Pazdur says a volunteer with a local rescue group for Maltese dogs -- an interest for her because of the couple's own pair of the tiny pooches, Cleopatra and Rebel -- once asked her to find out the fate at the FDA of a canine drug. FDA drug deliberations are confidential, and the couple says Dr. Pazdur doesn't discuss them at home.
At one point, Dr. Pazdur says the FDA received a complaint that Mrs. Pazdur's work in a clinical trial at the National Institutes of Health constituted a conflict for him. In fact, the type of product involved wasn't under his oversight. "You have to have a thick skin," Mrs. Pazdur says.
Chorus of Critics
Editorialists, bloggers and advocacy groups have zeroed in on him -- with criticism for denying some drugs and for approving others. Just 8% of cancer-drug candidates end up winning FDA approval, according to the Tufts Center for the Study of Drug Development. But most of the dropoff occurs long before they reach the agency, when they fail in studies. The FDA drug-approval rate for oncology in fiscal 2005-06 was fairly typical compared with other therapeutic categories, according to statistics from Parexel International Corp., a pharmaceutical-services firm.
Dr. Pazdur took flak over the FDA's 2003 decision to approve the AstraZeneca PLC lung-cancer drug Iressa. It helped shrink tumors in only 10% of patients in a limited study, while other clinical trials showed no significant benefit. But when an FDA advisory committee weighed Iressa, several patients spoke movingly about the medicine. The panel voted for approval, overruling a prominent statistician. The agency followed suit.
Then Iressa failed to show it could extend patients' lives in a large study. Dr. Pazdur says he awoke in the middle of the night, agonizing over what to do. In 2005, Iressa's use was severely restricted. Afterward, Dr. Pazdur sometimes internally cited Iressa as an example of the risk of approving a drug based on limited statistical evidence, according to people who have worked with him. The FDA's "decision has to be based on data," he says, speaking generally. "We don't approve drugs on testimonials."
Dr. Pazdur's approach has earned him a vigorous chorus of critics. He "has been a lethal disaster for cancer patients," says Steve Walker, a co-founder of the Abigail Alliance for Better Access to Developmental Drugs, an advocacy group. Mr. Walker and others criticize decisions like the FDA's 2006 rejection of Genta Inc.'s drug, Genasense, for a form of leukemia.
In a company-sponsored study of 241 people, patients taking Genasense were more likely to see signs of disease totally or nearly eliminated. But the FDA said the finding was of "questionable clinical significance." Patients taking Genasense didn't live longer, or show improvement in a broader measure of effectiveness, the agency said. The advisory committee voted against approval, and the drug was rejected.
Genta is appealing. The company's chief executive, Raymond Warrell, says his product was "held to a standard that far exceeds what anyone could reasonably require." The company has won support from a number of leukemia experts, some of whom have been researchers on Genta-sponsored studies.
Dr. Pazdur says the FDA is willing to give patients access to drugs that aren't approved, if approved treatments haven't worked. Some companies limit patient access to experimental therapies. Genta says it has a "compassionate use" program in the U.S. that allows patients access to its drug Genasense.
Dr. Pazdur dismisses personal criticism from what he calls "citizens against Pazdur." The attacks are often from "bullies," he says, and are "just an attempt to direct frustration, not the real issue of whether the drug works or not."
Write to Anna Wilde Mathews at anna.mathews@wsj.com2
URL for this article:
http://online.wsj.com/article/SB120528162144528849.html
Genitope Corporation to Suspend Development of MyVax(R) Personalized Immunotherapy
Monday March 10, 9:06 pm ET
FREMONT, Calif.--(BUSINESS WIRE)--Genitope Corporation (NASDAQ:GTOP - News) today announced that, based on a meeting with representatives of the U.S. Food and Drug Administration (FDA) to discuss the previously announced results of Genitope’s pivotal Phase 3 clinical trial of MyVax® personalized immunotherapy in previously untreated follicular B-cell non-Hodgkin’s lymphoma (fNHL) patients, Genitope intends to suspend development of MyVax® personalized immunotherapy. Genitope is evaluating its alternatives with respect to the other aspects of its business, including development of its monoclonal antibody program.
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Genitope previously announced that its Phase 3 clinical trial of MyVax® personalized immunotherapy did not meet its primary endpoint. In the primary analysis, there was no statistically significant difference in the progression-free survival (PFS) of patients receiving MyVax® personalized immunotherapy compared to patients receiving the control substance. However, analysis of a pre-specified endpoint in the MyVax® personalized immunotherapy arm showed a highly statistically significant difference in PFS between patients who mounted a positive immune response to the tumor-specific target and those who did not.
After a review of the data, the FDA has communicated to Genitope that, in light of the Phase 3 clinical trial’s failure to meet its primary endpoint, one or more additional Phase 3 clinical trials for MyVax® personalized immunotherapy would be required before the FDA would accept a Biologics License Application for FDA review. Genitope has determined that it is not feasible at this time to pursue further clinical trials of MyVax® personalized immunotherapy prior to receipt of FDA approval. Genitope is evaluating its alternatives with respect to the MyVax® personalized immunotherapy program.
“We are disappointed that we will not be able to make MyVax® personalized immunotherapy available to patients with follicular non-Hodgkin’s lymphoma,” said Dan W. Denney, Jr., Ph.D., chairman and chief executive officer of Genitope Corporation. “We firmly believe that MyVax® personalized immunotherapy has the potential to safely induce long-term remissions, possibly including life-long remissions. We greatly appreciate the support for MyVax® personalized immunotherapy that we have received from patients, clinicians, our employees and our stockholders. However, we recognize that the costs and time required for further clinical development of MyVax® personalized immunotherapy are prohibitive at this time, and we thus intend to focus our efforts on the development of our monoclonal antibody program.”
Genitope Corporation is evaluating its financial position and plans for continued operations and intends to provide additional information when available.
About Genitope Corporation
Genitope Corporation (Fremont, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Genitope Corporation's lead product candidate, MyVax® personalized immunotherapy, is a patient-specific active immunotherapy based on the unique genetic makeup of a patient's tumor and is designed to activate the patient's immune system to identify and attack cancer cells. Genitope is also developing a monoclonal antibody panel that it believes will potentially represent a novel, personalized approach for treating NHL. For more information about Genitope, please log on to http://www.genitope.com.
Perhaps the market was expecting more in the way of worldwide royalty income from Tyzeka. I know ramp ups take time, especially for a drug of this nature, but the market has been especially punishing lately. According to their most recent 8-k released on 3/6, Tyzeka worldide royalty income can't be much (the stock closed about $1 higher on 3/5 than where it is now):
For the fourth quarter ended December 31, 2007, Idenix reported total revenues of $12.6 million, compared with total revenues of $15.3 million in the fourth quarter of 2006. Total revenues for the fourth quarter of 2007 consisted primarily of reimbursement by Novartis of expenses incurred by Idenix in connection with the development of Tyzeka ® /Sebivo ® , the amortization of up front fees associated with development programs licensed by Novartis, and royalties associated with worldwide sales of
Tyzeka/Sebivo. The $2.7 million reduction in total revenues for the fourth quarter of 2007 as compared to the fourth quarter of 2006 is due primarily to lower development expenses associated with licensed programs and subsequent reimbursement of such expenses by Novartis.
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?dcn=0000950135-08-001615&Type=HTML
Dew - Nice calls on both MNTA and IDIX! (eom)
FWIW a Director bought 500 shares today (for his IRA).
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5491519
He is probably on a diving trip. Bet we hear from him next week.
Does RPRX have an SPA for the 65 patient PIIIs Anemia IND? That would be a large comfort factor.
Pazdur Comment on Avastin BC Approval:
We felt this is an effective drug for breast cancer,'' said Richard Pazdur, director of the agency's Office of Oncology Drugs, in a telephone interview. It was important to know that a second study [post marketing approval study], which the FDA requested, confirmed the benefit, Pazdur said.
The drug didn't show it could help people live longer in the E2100 study, although that could have been skewed by unknown circumstances, Pazdur said. The FDA still believes survival is the ``gold standard'' for cancer drugs, and if further Avastin studies don't demonstrate a benefit, the agency may require another advisory panel, he said.
http://www.bloomberg.com/apps/news?pid=20601103&sid=arfpSr.Bqdqc&refer=us
[but Breast Cancer Action were against approval]:
Breast Cancer Action, a patient advocacy group in San Francisco, said in a statement the decision is ``a victory for drug companies, but not for patients.'' The group argued that the FDA lowered its standards by approving the medicine without showing it improved survival time.
Patients on the drug had a 20 percent increase in serious side effects, including high blood pressure, blood clots and heart attack, the FDA said.
Any thoughts on future FDA caution on safety hold-ups for intranasal PM-150 or intranasal rylomine given that the FDA has placed YMI's intranasal opioid based pain-killer AeroLEF on clinical hold for safety concerns? How do JAV'S intranasal products stack up to YMI? Since 1/17 and prior to the shelf PR, JAV has been trading down. I am long JAV and any thoughts are appreciated.
http://biz.yahoo.com/prnews/080117/to248.html?.v=64
YM BioSciences provides update on AeroLEF(TM) clinical development program
Thursday January 17, 1:00 am ET
MISSISSAUGA, ON, Jan. 17 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the Company that the Phase II Acute Pain Study (AP5) of AeroLEF(TM) for which FDA clearance was announced on June 27, 2007, upon re-review of data from the IND submission, has been placed on clinical hold. The FDA has requested additional safety information on specific patients in previous clinical studies. The additional requested data is limited to a small group of patients that experienced oxygen desaturation, a class effect of opioids including fentanyl. The Company will conduct a subgroup analysis on these patients. To date, no patients have been dosed in the US AP5 study and there are no other clinical trials involving AeroLEF(TM) currently ongoing.
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"We are confident that we can provide the information the FDA has requested in a timely manner," said David Allan, Chairman and CEO of YM BioSciences. "We appreciate that the FDA has to ensure that any risk to patients during clinical trials is minimized and we understand their caution with opioid-based therapeutics."
Dr. Diana Pliura, Executive Vice President, AeroLEF(TM) added, "Data reported in May 2007 from our successful randomized Phase 2b trial demonstrated that patients had a statistical and clinical benefit from AeroLEF(TM). We remain strongly committed to the clinical development of this unique product."
YM BioSciences also reported that it held its scheduled End-of-Phase 2 (EoP2) meeting with the FDA on January 16, 2007 as planned.
YM recently reported that its lead drug, nimotuzumab, is in numerous trials internationally including a Phase III randomized trial in adult glioma and a Phase II/III randomized trial in patients with advanced pancreatic cancer. Data from the fully recruited Phase III trial in Europe in children with inoperable brain cancer, if positive, are expected to be submitted to the EMEA for marketing approval.
About AeroLEF(TM)
AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. In contrast to fixed-dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive delivery system designed to enable patients to self-titrate. Using AeroLEF(TM), patients can identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEF(TM), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
[Maybe the Best Solution to the Healthcare Crisis is to Eat and Smoke Alot]
Living longer is hazardous to the taxpayer
Preventing smoking, campaigning against obesity and fighting cancer may be the right thing to do, but while this may save lives, it certainly does not save money.
A study by Dutch researchers claims that the healthiest people cost the taxpayer more than the others over their respective lifetimes.
In a paper published online on Monday in the Public Library of Science Medicine journal, Dutch researchers found that the health costs of thin and healthy people in adulthood are more expensive than those of either fat people or smokers.
While smokers and the overweight are often criticised for the financial impact of their unhealthy lifestyles, an obese person's medical bills actually average 10 per cent less overall than those of a person of normal weight and smokers require even less treatment.
The reason for this, says the study, is the fact that healthy people live longer and may develop long-term diseases in old age like Alzheimer's which are very expensive to treat.
As a result, any savings made by them being healthy when young are more than offset by their being ill in old age.
On average, healthy people lived 84 years. Smokers lived about 77 years, and obese people lived about 80 years. Smokers and obese people tended to have more heart disease than the healthy people.
Cancer incidence, except for lung cancer, was the same in all three groups. Obese people had the most diabetes, and healthy people had the most strokes. Ultimately, the thin and healthy group cost the most, about US$417,000, from age 20 onward.
The cost of care for obese people was US$371,000, and for smokers, about US$326,000.
The results counter the common perception that preventing obesity will save health systems worldwide millions of dollars.
A Word Of Caution
However, Prof Klim McPherson of Oxford University cautioned that the research should not used as an excuse not to tackle rising levels of obesity.
He asked,''Is it worth knowing obese individuals are cheaper than lean ones for the health sector in the long run?''
The Dutch experts admitted that the effects of obesity and smoking stretched further than the health system, the Daily Mail reported.
''We have focused solely on healthcare costs, ignoring broader cost categories and the consequences of these risk factors to society,'' they were quoted by agencies as saying.
http://www.ibnlive.com/news/living-longer-is-hazardous-to-the-taxpayer/58164-17.html
I think the 1 employee was the receptionist:
Employees
As of March 30, 2007, the Company had one full-time employee and five employees that work on a part-time basis, including Mr. Seltzer and Mr. Kestenbaum. Mr. Seltzer and Mr. Kestenbaum are employed by other organizations and will continue to participate on a part-time basis, not devoting full-time efforts to the affairs of the Company for the foreseeable future.
12
--------------------------------------------------------------------------------
Corporate Information
The Company’s corporate headquarters are located at One Penn Plaza, New York, NY 10019. The Company’s telephone number is (212) 594-1215, and its fax number is (212) 798-8183.
Executive Officers and Significant Employees of the Registrant
The following sets forth certain information with regard to the executive officers of the Company as of March 30, 2007 (ages are as of December 31, 2006):
Name Age Position
Reuben Seltzer 50 President, Chief Executive Officer and Director
Alan Kestenbaum 45 Executive Vice President and Director
L. William McIntosh 61 Chief Operating Officer and Director
David Barrett 31 Chief Financial Officer
William Wong 59 Chief Scientific Officer
http://www.sec.gov/Archives/edgar/data/1328511/000114420407021498/v073034_10ksba.htm
OT - Microsoft Bids $44.6B for Yahoo
Friday February 1, 6:41 am ET
Microsoft to Pay $31 Per Share for Yahoo, Totaling $44.6 Billion in Cash and Stock
REDMOND, Wash. (AP) -- Microsoft Corp. offered to buy search engine operator Yahoo Inc. for $44.6 billion in cash and stock in a move to boost its competitive edge in the online services market.
Microsoft bid $31 per share for Yahoo, representing a 62 percent premium to Yahoo's closing stock price Thursday.
http://biz.yahoo.com/ap/080201/microsoft_yahoo.html?.v=4
Your very pretty great granddaughter? (just kidding) eom.
Some Things Take Time
FDA Reviewing Mecacor-OTC since 1999:
AP
Merck Says FDA Rejects Mevacor OTC
Friday January 25, 6:54 pm ET
Merck Says FDA Rejects Its Bid to Market Non-Prescription Cholesterol Drug Mevacor OTC
WHITEHOUSE STATION, N.J. (AP) -- Merck & Co. on Friday said the Food and Drug Administration rejected its application to market an over-the-counter cholesterol drug.
The FDA indicated that a 20 milligram dose of Mevacor OTC, or lovastatin, would require a revised label and additional data to obtain approval. Merck said it is evaluating its response, and indicated it will continue to push for clearance of Mevacor OTC.
The FDA has been reviewing a non-prescription 20 milligram dose of Mevacor since 1999, according to Merck. The FDA issued similar "not approvable" actions in 1999 and 2000.
It was another setback for Merck, whose Vytorin -- the popular cholesterol drug it sells with Schering-Plough Corp. -- has had its effectiveness questioned in recent weeks. The FDA held a press conference Friday to discuss its review of Vytorin.
Shares of Merck fell $1.77, or 3.6 percent, to close at $47.79. They earlier hit a 52-week low of $42.32, after ranging from $42.35 to $61.62 over the past year.
http://biz.yahoo.com/ap/080125/merck_mevacor.html?.v=1
Thomas A. Farrington Article
THE ROAD TOWARDS PROVENGE APPROVAL IN 2008
By: Thomas A. Farrington
President and Founder
PHEN
During the first two weeks of 2008 the US Food and Drug Administration’s (FDA’s) delayed approval of Provenge, the first ever prostate cancer therapeutic immunotherapy vaccine, continues to be a headline issue as it was for most of 2007. In fact the issue seems to be gaining momentum with a focus on reasons “why” the treatment was not approved by the FDA after being recommended for approval by an FDA advisory committee in March 2007.
“In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA’s decision last May to delay approval of Provenge;” states the editorial in the January issue of “Nature Biotechnology.”
Having had the opportunity to present before the FDA advisory committee convened to consider Provenge approval last March, I along with all the other survivors and advocates who presented, urged this committee to recommend approval based upon an unmet treatment need and the scientific data from the Provenge clinical trials. We were elated when the committee voted 17 to 0 that Provenge was safe and 13 to 4 that it met the FDA’s efficacy standards - an overwhelming recommendation to the FDA for approval.
Finally, we thought, there would be a treatment for terminally-ill prostate cancer patients without the severe side effects brought on by chemotherapy – the only existing treatment for late stage disease. Also, Provenge would provide a treatment for those thousands of terminally–ill prostate cancer patients unable to endure toxic chemotherapy, those like my father who died from this disease with no available treatment option. In addition we envisioned the potential for Provenge to open doors for a whole new class of immunotherapy treatments that could possibly be effective at earlier disease stages while maintaining a better quality of life for patients than today’s treatments. All of these hopes were put on hold when the FDA rejected the recommendation of its own advisory committee and directed Dendreon, the company behind Provenge, to continue with its clinical trials and come back with more data on Provenge’s efficacy.
The outcry from the patient community against the FDA’s decision has been strong and persistent, keeping the Provenge issue alive and leading to the current state where the US Congress is “likely” to investigate. For the millions of prostate cancer survivors this issue is about preserving lives and the quality of our lives. From various accounts it now appears that our interests and needs may not have been the priority with the FDA’s decision making process. The “Nature Biotechnology” editorial cites “irregularities” consisting of financial and other conflicts of interests on the part of some of those involved in shaping the FDA’s decision. It is my understanding that these irregularities would be the subject of a congressional investigation. I would hope, and believe, most everyone will applaud and support all actions to expose and punish individuals involved in an inhumane conspiracy to deny a safe and effective treatment from suffering and dying men.
Moving forward we must also keep our eyes on the prize – Approval of a breakthrough and landmark prostate cancer treatment. During 2008 Dendreon is scheduled to provide the FDA with new interim data from its on-going Provenge clinical trials. With the events of the past year as lessons learned that should guide us, we must demand that the FDA’s evaluation of this data, and complete decision making process, is expedited and totally transparent to the public. The FDA should clearly outline the process that will be used in determining whether the interim data supports Provenge approval. The agency should also outline how approval can be expedited if the data meets approval conditions, and it should commit to this expedited process. And again, every single FDA action taken in this process should be open and transparent to the public.
The hopes and excitement of prostate cancer survivors exhibited across this country following the FDA advisory committee’s positive recommendation in March 2007 are still alive, and the unmet treatment needs still exist. Millions of prostate cancer survivors sit on the time bomb of a cancer recurrence knowing that with treatments available today this will mean a compromised quality of life, and in many cases death. For African American families, where men experience a prostate cancer death rate 2.5 times that of other men, there is added urgency for new treatments to relieve a widespread and frightening epidemic of suffering. All survivors realized a setback with the FDA’s decision to delay approval of Provenge in 2007, but we must and will persevere until we get a fair assessment whether Provenge is an answer to our needs – The FDA’s own advisory committee thought it was. We see no other treatment options on the immediate horizon with the potential impact of Provenge, so we have no choice but to see this single option fully exhausted.
For men in the US, prostate cancer is the leading cause of cancer and the second leading cause of cancer deaths. Prostate cancer patients are in desperate need for new treatments that will save lives and the quality of lives. A transparent, fair and expedited FDA review for Provenge is a critically important step in helping meet this need, and restoring some confidence in an FDA process that is suspected of serious “irregularities.” The US Congress needs to also insure that this critical step is taken.
http://www.prostatehealthed.org/phen_Detail.php?News=673
OT: I would like to say that Aschoff is a scumbag, but then Dew would write me up for a TOS. See 1 and 2 below.
1)
FDA Approves ZymoGenetics' RECOTHROM(TM) Thrombin, topical (Recombinant)
Thursday January 17, 1:45 pm ET
- First recombinant plasma-free thrombin for use in surgical hemostasis -
- $40 million milestone payment from Bayer -
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today announced that the United States Food and Drug Administration (FDA) has approved RECOTHROMTM Thrombin, topical (Recombinant) for sale. RECOTHROM, previously referred to as recombinant thrombin (rThrombin), is the first and only recombinant, plasma-free thrombin approved for use as a topical hemostat. RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. A Phase 3 pivotal clinical trial showed that RECOTHROM had comparable efficacy and a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product.
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“The FDA approval of RECOTHROM recombinant thrombin is important news for patients, surgeons and hospitals,” said Bruce L.A. Carter, Chief Executive Officer. “We believe that RECOTHROM has important features and benefits. We’re well prepared for launch and expect to ship product in the near future.”
Under a global collaboration, Bayer HealthCare Pharmaceuticals will support the launch of RECOTHROM in the US for three years. Both ZymoGenetics and Bayer field representatives, medical science liaisons and sales personnel have been thoroughly trained. The FDA approval triggers a $40 million milestone payment from Bayer HealthCare to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to $20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.
In June 2007 Bayer HealthCare acquired the rights to RECOTHROM in all markets outside the US. Bayer will commercialize RECOTHROM leveraging the company’s strong commercial presence in global markets. Bayer will be responsible for conducting any required clinical trials, securing regulatory approvals and commercializing the product in all countries outside the US.
“The first regulatory approval of RECOTHROM is a significant signal of the product’s strong clinical data,” said Hans Bishop, head of Bayer’s global hematology/cardiology business unit. “RECOTHROM is an attractive addition to our specialty pharmaceutical portfolio. Our partnership with ZymoGenetics demonstrates Bayer’s continued focus on working collaboratively with innovative biotechnology companies to develop and commercialize novel protein therapeutics.”
ZymoGenetics Down on 'Sell' Initiation
Wednesday January 16, 7:15 pm ET
ZymoGenetics Falls As Analyst Starts Coverage at 'Sell' on Possible Product Delays
NEW YORK (AP) -- Shares of biotechnology company ZymoGenetics Inc. fell Wednesday after a Brean Murray, Carret & Co. analyst started coverage with a "Sell" rating, saying the company's lead experimental product could face further approval delays.
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Seattle-based ZymoGenetics is seeking approval for blood-clotting product Recothrom, or rThrombin, to be used when standard techniques cannot control bleeding in patients.
2) Aschoff's call yesterday:
In a note to investors, analyst Jonathan Aschoff questioned the likelihood Recothrom will receive outright approval from the Food and Drug Administration, based on its safety profile.
He noted that the development and regulatory pathways for Recothrom have been mired with problems. In August, ZymoGenetics cut its revenue guidance after the FDA postponed a decision date on rThrombin upon receiving additional manufacturing-related information from the company.
"We question the product's outright approvability based on the clinical safety data generated to date, ZymoGenetics' manufacturing capabilities, and the company's claims to superior safety in regards to live-sourced thrombin," said Aschoff.
The analyst predicted the FDA will issue ZymoGenetics a "complete response letter" on Thursday, the date when the FDA is expected to release a decision on the drug's application. Such letters often request additional data and information on a drug candidate before the review is completed.
Aschoff said he expects late-stage trial results for Recothrom in the third quarter, and believes the FDA will wait for those results before approving the product, saying the market for this type of treatment is already well-served.
Even if the drug is approved, Aschoff sees it facing tough competition from similar products by Johnson & Johnson and King Pharmaceuticals Inc.
"We believe that further regulatory delay for Recothrom will also force ZymoGenetics to raise substantial capital at an unfavorable valuation, as we project a cash raise before the Phase 3b results are released," he added.
On the upside, Aschoff believes the company's pipeline is promising in the longer term in the auto-immune and cancer areas.
He put a $7 price target on ZymoGenetics shares.
ZGEN just got approval - shows you what a moron Aschoff is.
Dendreon Receives European Patent Covering PROVENGE(R) and Company's ACI Platform Technology
Tuesday January 15, 7:00 am ET
SEATTLE, Jan. 15 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced that the company has been granted a broad European patent covering the company's lead product candidate PROVENGE® (sipuleucel-T), the Company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer. European patent No. 0 870 022 B1 covers the composition of matter of PROVENGE as well as the company's other active cellular immunotherapy (ACI) product candidates, such as NEUVENGE(TM) (lapuleucel-T), which utilize Dendreon's Antigen Delivery Cassette(TM) technology. The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.
"The approval of this broad patent covering PROVENGE and our other active cellular immunotherapies in Europe is an important milestone for the company," stated Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "While our priority is to obtain the approval of PROVENGE in the United States, the issuance of this key patent solidifies the commercial potential of PROVENGE and our ACI platform on a more international basis.
CEGE - Vital 1 continues at interim;
Cell Genesys"s PR......
Genesys' VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
Monday January 14, 9:00 am ET
Conference Call Scheduled for 10:00 a.m. ET Today
SOUTH SAN FRANCISCO, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced that the Independent Data Monitoring Committee (IDMC) for VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, has completed a pre-planned interim analysis and has recommended that the study continue. This event-driven interim analysis was designed to determine whether the study should continue to completion and took place in the time frame originally estimated. As is customary to preserve study blinding, the IDMC provided no information to the company other than the recommendation to continue the trial.
"The IDMC's recommendation to continue with the VITAL-1 trial represents an important step forward in the Phase 3 development of GVAX immunotherapy for prostate cancer and in our effort to make this product available as a new treatment option for men with prostate cancer," stated Robert Dow, MBChB, chief medical officer of Cell Genesys. "Moreover, we can currently estimate that we will reach the required number of events needed to conduct the final analysis in the second half of 2009."
VITAL-1 is a multi-center, randomized, controlled Phase 3 clinical trial designed to compare GVAX cancer immunotherapy to Taxotere® (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer (HRPC) patients with metastatic disease who are asymptomatic with respect to cancer- related pain. The primary endpoint of the trial is an improvement in survival. VITAL-1 was initiated in July 2004 and completed recruitment of 626 patients in July 2007. Patients were enrolled at approximately 130 sites in North America and Europe.
The company's second Phase 3 trial, VITAL-2, is a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in HRPC patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial is also an improvement in survival. VITAL-2 was initiated in June 2005 and is currently enrolling patients at approximately 90 sites in North America and Europe. The company expects to complete enrollment of approximately 600 patients in the first half of 2009 and if this is achieved, to have a sufficient number of events for a pre-planned interim analysis at that time.
The U.S. Food and Drug Administration (FDA) granted Cell Genesys Special Protocol Assessments (SPAs) for both VITAL-1 and VITAL-2. The SPA is a process that allows for official FDA evaluation of a Phase 3 clinical trial and provides trial sponsors with a binding written agreement that the design and analysis of the study are adequate to support a license application submission if that study is performed according to the SPA. Cell Genesys completed the modifications requested by FDA during the review process.
About GVAX Cancer Immunotherapies
GVAX cancer immunotherapies are non patient-specific investigational therapeutics comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and then irradiated for safety. GVAX is designed to be administered through intradermal injections on an outpatient basis. To date, over 600 patients have been treated with GVAX cancer immunotherapies in Phase 1 and Phase 2 clinical trials for multiple indications, including prostate cancer, pancreatic cancer, and leukemia. The company is currently manufacturing GVAX immunotherapy for prostate cancer in its bioreactor manufacturing plant in Hayward, California, a facility that is also capable of manufacturing the product during commercialization.
Conference Call and Webcast
Members of the Cell Genesys management team will host a conference call today, Monday, January 14 at 10:00 a.m. ET to discuss today's announcement. Investors may listen to the webcast of the conference call live on the investor section of the Cell Genesys website, http://www.cellgenesys.com. Alternatively, investors may listen to a replay of the call by dialing 800-475-6701 from locations in the United States and 320-365-3844 from outside the United States. The call-in replay and webcast will be available for at least 72 hours following the call. Please refer to reservation number 907247.
http://biz.yahoo.com/prnews/080114/aqm079a.html?.v=1
New 13G just out
Efficacy bought a little more.
OT Wall and Clark - ZGEN:
Thought this PR might be of interest to some here, but it's a small P2:
ZymoGenetics Begins Phase 2 Trial in Renal Cell Cancer Evaluating IL-21 Combined with Nexavar(R)
Tuesday January 8, 6:00 am ET
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today announced that the company has initiated Phase 2 testing of Interleukin 21 (IL-21) in combination with Nexavar® (sorafenib) tablets in patients with advanced renal cell cancer. The Phase 2 study is part of a Phase 1/2 clinical trial and will examine patients treated with the maximum tolerated dose identified in the recently completed Phase 1 dose escalation phase.
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“We’re encouraged by the results of the Phase 1 portion of this trial and are convinced that IL-21 in combination with Nexavar deserves further evaluation in renal cell cancer,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “In Phase 2, we’ll continue to evaluate the tolerability and anti-tumor activity of this combination therapy in patients with late stage renal cell cancer.”
The primary objective of the open label multi-center Phase 2 study is to characterize safety of IL-21 with Nexavar at the recommended dose; a secondary objective is to evaluate anti-tumor activity, which will be assessed by evaluating tumor response and progression free survival. The trial is expected to enroll approximately 30 patients. The study is evaluating the combination in patients with clear cell carcinoma, which accounts for 85% of all renal cell tumors.
Results from the Phase 1 Trial with IL-21 and Nexavar
Interim results from the Phase 1 trial of IL-21 in combination with Nexavar in patients with renal cell cancer were presented in October 2007 at the AACR-NCI-EORTC International Conference. That data indicated that the combination of IL-21 and Nexavar is well tolerated, with a toxicity profile similar to known toxicities of each agent alone. Preliminary evidence of anti-tumor activity was also documented in the majority of the patients treated in Phase 1.
Renal Cell Cancer
There will be an estimated 51,190 new cases of renal cell carcinoma in the U.S. in 2007. It is estimated that renal cell carcinoma will result in approximately 19,600 deaths in the U.S. in 2007. Renal cell carcinoma accounts for approximately 2% of cancers world wide. There is a clear need for new and improved therapies for renal cell cancer.
IL-21 in Combination with Tyrosine Kinase Inhibitors
Because tyrosine kinase inhibitors (TKIs) such as Nexavar and Sutent® (Sunitinib) inhibit the growth of tumor cells and act on the underlying vasculature, and IL-21 activates the immune system to target killing of tumor cells, the two therapies may provide additive effects. Treatment with a TKI may make cancer cells more sensitive to natural killer or T cell mediated killing after activation with IL-21. Preclinical research conducted by ZymoGenetics of TKIs and IL-21 found that IL-21 had additive anti-tumor effects when combined with a TKI in a renal cell cancer model.
Previous IL-21 studies
Previous clinical studies with IL-21 alone have shown that IL-21 is an active cytokine that can be administered in an outpatient regimen. Results from a Phase 1 study presented at the American Society of Clinical Oncology (ASCO) 2006 annual meeting showed that IL-21 administration was tolerable in an outpatient setting and reductions in tumor size were observed in several patients. Available clinical data support further clinical investigation of IL-21 as a new therapeutic agent for the treatment of cancer.
About IL-21
Endogenous IL-21 has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play important roles in eliminating malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of animal models, ZymoGenetics is developing a recombinant form of IL-21 for the treatment of cancer, initially in metastatic melanoma and renal cell carcinoma and has retained commercialization rights for IL-21 in North America. The company licensed commercialization rights outside of North America to Novo Nordisk A/S.
About ZymoGenetics
ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The company is developing a diverse pipeline of product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune and viral diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.
Courtesy of Dew on BV:
BSMD Reports 3-Year UF Embolization Data
http://biz.yahoo.com/bw/080102/20080102005543.html?.v=1
>>
Three-Year Data from 1,278 Women Published in Obstetrics & Gynecology Demonstrates Long-Term Efficacy and Durability of Uterine Fibroid Embolization (UFE)
Wednesday January 2, 11:21 am ET
UFE Shown to Offer a Safe, Effective, Minimally Invasive, Uterine-Sparing Option for Symptomatic Women with Uterine Fibroids
ROCKLAND, Mass.--(BUSINESS WIRE)--BioSphere Medical, Inc. (NASDAQ: BSMD ) (“BioSphere”), a medical device company that has pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors, and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy, today announced that three-year outcomes data from the FIBROID Registry just published in the January 2008 issue of Obstetrics & Gynecology concluded that over the long term, and in a broad range of practice settings, uterine artery embolization (or “uterine fibroid embolization” or “UFE”) produces a high level of durable symptom control and results in a significant improvement in a woman’s health-related quality of life. Earlier today, the Society of Interventional Radiology (SIR) said, “Three-year data from the largest, multi-center, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90 percent of the women participating avoided a hysterectomy, and of these, 85 percent had a substantial improvement in symptoms and quality of life.” Additional information about UFE, and other links of related interest, can be found on the SIR’s Web site, www.sirweb.org, on BioSphere’s Web site, www.biospheremed.com, and on www.ask4ufe.com.
Richard Faleschini, BioSphere Medical’s President and Chief Executive Officer, commented, “The three-year outcomes reported in this key study are consistent with other peer-reviewed UFE investigations published in the last two years within and outside the United States, and provide additional and important validation of the long-term efficacy and durability of UFE. Also, in 73% of the cases in this Registry, the primary embolic agent used was BioSphere Medical’s calibrated embolic, thus providing specific affirmation of the effectiveness of our tris-acryl microspheres. Another key finding reported in this study was that the reintervention rate for UFE was low, and compared very favorably to the reintervention rate of myomectomy, the surgical gold standard. In addition, the mean time to return to work for the patients who completed the follow-up to the study was 8.8 days. Based on the compelling results of this Registry — patient satisfaction, clinical efficacy, and return to normal daily activities — we believe that UFE should be considered among first-line therapeutic options for the treatment of uterine fibroids for the majority of women suffering from this common and incapacitating disease.”
The Fibroid Registry for Outcomes Data for Uterine Embolization study was funded through the Society for Interventional Radiology Foundation with funding in part from BioSphere Medical.
About Uterine Fibroids
Symptomatic uterine fibroids are a public health concern, occurring in at least half of American reproductive-age women. Uterine fibroids may cause pain, abnormal bleeding, pressure, and other symptoms related to uterine enlargement. Symptomatic uterine fibroids lead to 30-40% of all hysterectomies in the United States and to 150,000-200,000 hysterectomies annually. More than 25% of all women will have a hysterectomy by the time they are 60 years old, making it the second most frequently performed surgical procedure (after cesarean delivery) for women of reproductive age in the United States.
About BioSphere Medical, Inc.
BioSphere Medical, Inc., a medical device company based in Rockland, Massachusetts, seeks to pioneer and commercialize minimally invasive diagnostic and therapeutic applications based on proprietary bioengineered microsphere technology. The Company's core technologies, patented bioengineered polymers and manufacturing methods, are used to produce microscopic spherical materials with unique beneficial properties for a variety of medical applications. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE. The Company's products continue to gain acceptance in this rapidly emerging procedure as well as in a number of other new and established medical treatments.
<<
Ranch - thought you might find this article interesting, courtesy of Preciouslife1 on BV:
http://www.sciencedaily.com/releases/2007/12/071228215533.htm
Clark – Not trying to be a wise ass, but
You wrote on the BV board earlier today the following:
“If you give me a trial size, a number of events and the resulting HR I will tell you the p value with fairly tight tollerances.”
http://investorshub.advfn.com/boards/read_msg.asp?message_id=25460115
How about two trials: 1) with 180 events and a sensitivity analysis with HRs ranging from 1.1 to 1.5 (maybe in .05 increments), what would the resulting log p-values be? 2) with 360 events and a sensitivity analysis with HRs ranging from 1.1 to 1.5 (maybe also in .05 increments), what would the resulting log rank p-values be? I guess such an analysis would not take into account the shape of the survivor curves, so just assume these are the overall HRs for the trials.
Just hypothetical, of course. I have no specific trial in mind ;)
I assume this would not be a great deal of work for you, as I suspect that you have some stats model set up and it would just be just plugging in the variables.
Thanks for you thoughts and have a Very Happy Holidays.
Steve
OT: PBS show entitled "DNA" is very interesting, especially segment on cancer. I recommend it. Check your local listings.
SaulK
In the event that criminality is exposed, do you see any deep-pocketed defendants out there? What would be the chances of a $billion settlement? Would the appeals be settled this century? Would your brethren take the lion’s share of the proceeds? Do you think Sloan Kettering would make a nice East River condo? I ask these questions as someone who bailed entirely on 5/9?
Thanks
Maybe, Maybe Not
Please read the last line in the actual letter to Dingell et al:
December 13, 2007
The Honorable John Dingell The Honorable Joe Barton
Chairman Ranking Member
Committee on Energy and Commerce Committee on Energy and Commerce
2125 Rayburn HOB 2322-A Rayburn HOB
Washington, DC 20515 Washington, DC 20515
The Honorable Frank Pallone The Honorable Nathan Deal
Chairman Ranking Member
Subcommittee on Health Subcommittee on Health
Committee on Energy and Commerce Committee on Energy and Commerce
2125 Rayburn HOB 2322-A Rayburn HOB
Washington, DC 20515 Washington, DC 20515
Dear Chairman Dingell and Ranking Member Barton and Subcommittee Chairman Pallone and Ranking Member Deal:
We are writing to express our serious concerns about the failure of the Food and Drug Administration’s (FDA) to approve the licensure of Provenge, (sipuleucel-T), a potentially life-saving therapy for those suffering from advanced prostate cancer. We write to request the Committee on Energy and Commerce conduct a hearing to examine the conflict of interests governing the FDA in this decision.
While much has been written on both sides of the issue about the effectiveness of the therapy known as Provenge, there is reason to believe that serious ethics rules were violated by two FDA advisory panel members in their decision and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time.
In March, the FDA's expert advisory panel (comprised of leading immunotherapy experts, oncologists, and statisticians) voted unanimously that Provenge is safe and voted 13-4 that it was effective, meeting the statutory burden of proof provided for in FDAMA for immediate licensure of Provenge while the sponsor of this therapy continued and completed its ongoing study. Overruling this panel of scientific experts, the FDA ordered additional clinical trials which won't be completed until 2010.
Prostate cancer activists have raised questions about two of the negative voters, academic medical oncologists Maha Hussain and Howard Scher. Dr. Howard Scher is lead investigator for a competing cancer drug made by Novacea and is listed as an adviser to a large venture capital firm that is also a major investor in Novacea. We believe the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge nor should the FDA appoint an adviser to a large investor in such a competitive firm as a panel member. It is important that Congress examines possible ethical violations of these panel Members considering the viability of potentially important life-saving drugs.
A lawsuit was recently filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus. The lawsuit accuses FDA of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy.
Over the last few years, FDA has repeatedly failed to take substantive action to effectively restore confidence in the agency. According to its January 2007 report to Congress, the FDA granted waivers to 24 percent of the 928 members of its 47 advisory committees that met during the 14 month period from November 10, 2005 through January 4, 2007.
We believe that the FDA can and should eliminate these conflicts of interest so that everyone involved -- patients, doctors, companies, scientists, investors and the public -- believes the process has been fair and evenhanded, and the end result dictated by the science. Top-notch scientists without such substantial conflicts are available to the FDA now and are willing to serve, as noted in a recent letter to Senators Kennedy and Dodd by a number of prominent physicians, including two former editors of the New England Journal of Medicine.
The Food and Drug Administration Modernization Act of 1997 intended to make the regulatory process less arbitrary and more transparent. We must strengthen and streamline the process to ensure prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.
We request your committee conduct a hearing to discuss the FDA’s role in this recent decision and the conflicts of interests in the agency. Thank you for your consideration of our request.
<With a given number of events at the interim and an allocated p value, is the Hazard Ratio determined automatically or does the shape of the curve or some other factor(s) make it a variable independent of events and p value?>
I am not the person to answer this, but I think the answer is both. It can be both instantaneous at all points along the curve, and overall at the end. The instantaneous HRs along the curve builds to overall HR. What worries me about the interim is the potential low HRs for patients enrolled less than 24 mos. (over 40% of the pop. at 4Q08 ) squeezing the hell out of the overall HR and p-value to that point.
% alive
9901 6 months 12 months 18 months 24 months 30 months 36 months
Provenge 91.5 76.8 67.1 52.4 43.9 34.1
Placebo 93.3 66.7 55.6 40.0 24.4 10.7
dif -1.8 10.1 11.5 12.4 19.5 23.4
hr 0.98 1.15 1.21 1.31 1.80 3.19
% alive
9902a 6 months 12 months 18 months 24 months 30 months 36 months
Provenge 92.3 72.3 52.3 44.6 41.5 31.6
Placebo 90.9 69.7 45.5 39.4 27.3 21.2
dif 1.4 2.6 6.8 5.2 14.2 10.4
hr 1.02 1.04 1.15 1.13 1.52 1.49
This table will probably be garbled, but if others agree with its validity I can PM it to you.