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To: Jon Khymn who wrote (31361)5/31/2009 9:08:18 AM
From: tom pope
   of 42319
 
Consultants.

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To: Arthur Radley who wrote (31339)5/31/2009 11:41:36 AM
From: Arthur Radley
   of 42319
 
As the American Society of Clinical Oncology(ASCO) began its annual conference today in Orlando, physicians prepared to deal with a topic that is rarely addressed but highly relevant to today’s cancer care providers: comparing the rising cost of treatment to the smaller and smaller benefits that treatment provides.

A report from the American Cancer Society released in February found that even people who have health insurance can be bankrupted if they test positive for cancer. Of those with insurance, one in five people living with cancer use up all or most of their savings. One of the report’s authors, Christy Schmidt, told ABCnews.com, “Just because you’re insured doesn’t mean that you’re not going to have… very, very serious financial problems,” she said. “The very design of insurance policy itself can cause significant expenditures, even leading to bankruptcy or loss of home for some people.”

“Decades of investment in cancer research have led to important advances in screening and treatment, and vastly improved cancer survival rates,” said ASCO President Richard L. Schilsky, MD.

While advances in technology and distribution of care have improved our rate of survival, an overall increase in the incidence of cancer in America will occur over the next twenty years, according to an article published yesterday in the Journal of Clinical Oncology. For the general population, the chance of getting cancer will increase by 45%; for whites, 31%, and for minorities, 99%. Doubling the risk of cancer also doubles the expense, stress, and pain due to treatment methods.

One of the presentations kicking off the annual ASCO conference, the Lung Screening Study, bears bad news for those who advocate for CT in the detection of lung cancer. Low-dose computed tomography, or CT, is a high-tech scanning technique that creates a series of cross-sectional images, similar to an x-ray. It is widely used by most treatment centers in the U.S. The problem with CT, reports Dr. Jennifer Croswell of the Lung Screening Study, is that for every two correct positive results for cancer it generates, it produces one false positive.

“There is no question that CT screening will detect many lung cancers,” Dr. Martin Edelman of the University of Maryland’s Cancer Center told ABCnews.com, but there is “a complete absence of evidence that this approach decreases mortality or morbidity due to lung cancer,” he said.

Advocates for CT have long claimed that there is little or no risk of harm from screening, but the Lung Screening Study “demonstrates that there is a small but real potential for harm,” according to Edelman.

False positives create unnecessary psychological stress in patients and their families, unnecessary burdens on the healthcare system, and invasive and potentially dangerous follow-up tests. Lung cancer is responsible for 15% of all cancer cases but 28% of all cancer deaths; new research like the Lung Screening Study is critical to improving the state of cancer care in the U.S.

Dr. Peter B. Bach of Memorial Sloan-Kettering Cancer Center in New York spoke with reporters about the new study which revealed CT to be misleading 33% of the time. Bach said real-world physicians don’t operate on a “yes-no” basis. “The way the authors analyze it — calling them all positive — rigs the study toward finding an extremely high false-positive rate,” he said. Bach has reported financial links with Genentech, Wyeth, Abraxis, Biogen-Idec, and Johnson and Johnson.

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From: Arthur Radley5/31/2009 3:11:24 PM
   of 42319
 
(EXEL and BMY)
Here we go again..........how can a biotech and major pharma like (BMY) miss report response rates by a NOW 15% vs an earlier reported rate of 38%?

reuters.com

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To: Arthur Radley who wrote (31364)5/31/2009 8:19:54 PM
From: Ian@SI
1 Recommendation   of 42319
 
how can a biotech and major pharma like (BMY) miss report response rates by a NOW 15% vs an earlier reported rate of 38%?

In part, probably because apples and oranges are being compared.

10 Responses out of 26 Assessed pts gave 38% rate.
20% of previously treated pts (n=?) responded.
7 responses out of 46 pts (undefined group) gave the 15% rate.

It's unclear to me that either company misreported anything. I'd suspect Reuters of shoddy reporting first.

BWDIK
Ian

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To: Arthur Radley who wrote (31364)5/31/2009 8:35:01 PM
From: Ian@SI
1 Recommendation   of 42319
 
Just looked at the PR from EXEL. I don't see any misreporting by anyone, just a focus on a small subset of the numbers reported by the companies in that PR.

extract with all the numbers:

...

Exelixis is co-developing XL184 with Bristol-Myers Squibb Company. John
De Groot, MD, of The MD Anderson Cancer Center, and an investigator on
the Phase 2 GBM trial, will present the data in a poster session
(Abstract #2047) from 8 a.m. to 12 p.m. local time on Sunday, May 31,
2009, at the American Society of Clinical Oncology (ASCO) Annual
Meeting, which is being held May 29-June 2 in Orlando.




The exploratory study is evaluating the safety, tolerability and
clinical activity of XL184 at a continuous daily dose of 175 mg in
patients with previously treated GBM. To date, 46 patients who make up
the intent to treat (ITT) population have been enrolled in the trial,
including 30 (65%) in first relapse and 16 (35%) in second or third
relapse. Importantly, the trial did not exclude patients previously
treated with an antiangiogenic agent.




Tumor response, as determined by an independent radiology facility
(IRF), using MacDonald criteria were reported. By ITT analysis, 7 of 35
(20%) of the antiangiogenic naive patients had a confirmed partial
response. The overall rate of response in all patients, including the
refractory population of previously treated patients with an
antiangiogenic therapy, was 15%. The median duration of response by IRF
was 2.9 months (range = 1.9-8.6 months). In an exploratory analysis,
among 35 patients with at least one post baseline MRI scan, 12 (34%) had
tumor shrinkage ≥50% as their best response as determined by
investigator, including 1 patient who had received prior antiangiogenic
therapy.




The efficacy evaluable population was defined as patients having
received at least 1 dose of XL184 and either had at least 1
post-baseline tumor assessment per investigator or failed to return for
any tumor assessments because of death or clinical determination of
progression. In the anti-angiogenic naive population, 7 of 31 (23%) of
efficacy evaluable patients had a confirmed partial response by IRF. The
6-month progression-free survival (PFS) rate in patients receiving no
prior antiangiogenic therapy was 23%, with 10 patients censored for PFS
at the time of analysis, and the median PFS interval was 3.6 months.




"These initial data from our ongoing GBM program are encouraging, and
suggest that XL184 could have utility in this underserved indication,"
said Michael M. Morrissey, Ph.D., president of research and development
at Exelixis. "We believe that these data support continued evaluation of
XL184 in patients with GBM, and we intend to enroll additional patients
in this study to better assess the compound's anti-tumor activity and
safety profile in this difficult to treat patient population."




All 46 patients were evaluated for safety. Most adverse events were of
Grade 1 or 2 severity. The most frequently occurring Grade 3 and Grade 4
adverse events were: fatigue (30%), alanine aminotransferase increase
(9%), confusional state (9%), lipase increase (9%), lymphopenia (9%),
convulsion (7%), headache (7%), and hypophosphatemia (7%). Adverse
events of special interest were: hypertension (all incidences, 39%;
Grade 3/4, 7%), palmar-plantar erythrodysesthesia (30%; 7%), bleeding
events (28%; 9%), proteinuria (26%; 0%), pulmonary embolism (9%; 7%) and
craniotomy wound dehiscence (4%; 2%).




In the study, 87% of patients had a dose interruption of XL184, median
average daily dose was 122 mg/day. XL184 will be evaluated at a lower
dose of 125 mg daily in order to provide continuous and sustained
exposure to the drug in this previously treated glioblastoma population.


...

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To: Biomaven who wrote (31011)5/31/2009 8:39:00 PM
From: IRWIN JAMES FRANKEL
2 Recommendations   of 42319
 
>>If it is a cytokine storm then I'd be tempted to try the combo below (plus an ACE inhibitor or ARB for good measure):

This looks like a future possibility:

health.usnews.com

Rheumatoid Arthritis Drug Might Fight Swine Flu
It helps regulate the immune system's response, study with mice shows
Posted May 29, 2009

By Amanda Gardner
HealthDay Reporter

FRIDAY, May 29 (HealthDay News) -- Scientists are exploring the possibility that drugs that affect the immune system might one day serve as potent weapons to fight the flu, even the swine flu that's currently circulating around the globe.

The concept has worked with a group of lab mice that were treated with the rheumatoid arthritis drug abatacept (Orencia) after being given a lethal dose of influenza A virus, researchers report.

The mice were also loaded up with "memory" T-cells -- white blood cells that were programmed to react to this strain of flu.

Eighty percent of the treated mice lived, compared to only 50 percent of those left untreated, said Donna Farber, senior author of a paper published in the June 1 issue of The Journal of Immunology.

Basically, the drug enabled infection-fighting "memory" T cells to fight off the initial infection, but prevented them from overactivating the immune system, a process that can cause worse illness and even death.

The findings could have implications not only for the seasonal flu, which reappears with regularity each year, but for surprise outbreaks such as the swine flu.

"For the swine flu, there really are indications that you do get this sort of hyperimmune reaction," said Farber, who is a professor of surgery and microbiology and immunology at the University of Maryland School of Medicine in Baltimore. "Currently there is no treatment for people who are really ill from the flu, and there is already an indication that the immune system is too revved up [in these severe cases]. This could be a potential treatment for the flu."

The study was sponsored by Bristol-Myers Squibb, which makes Orencia, and the U.S. National Institutes of Health.

Orencia was approved for use in the United States in 2005 and introduced to the market in early 2006 to treat rheumatoid arthritis, an autoimmune disorder. It prevents activation of T lymphocytes, or white blood cells, whose function is to fight off infection.

"Memory" T-cells are a subset of T lymphocytes. They are "good" in that they can fight off an invading virus, but "bad" because they can also contribute to a hyperactive immune system that can lead to more illness and even death.

When a person becomes infected with a flu virus, the immune system dispatches these white blood cells to the lungs to get rid of the virus. But, if the cells don't know when to stop, they can cause tissue damage in the lungs, pneumonia and even death, Farber said.

"About half of your T-cells are memory T-cells. They persist and remember that you've seen a pathogen," she explained. "A response [to infection with the influenza virus] is likely to include some contribution of memory T-cells."

"With a lot of influenza, especially these pandemic strains, what really makes you sick and causes pneumonia is your immune response," Farber added.

The researchers injected mice with memory T-cells that had been programmed to react to an H1N1 strain of influenza A virus (the same "subtype" as the currently circulating swine flu) and then infected them with either a sub-lethal or lethal dose of the actual virus. In addition, at the start of infection, before the mice actually fell ill, half were given Orencia while the remaining half were left untreated.

In both sets of mice, those that had received Orencia cleared the virus quicker, got less sick and recovered faster than mice in the control group. The drug also tempered the immune response of the memory T-cells, the researchers found.

"It didn't dampen the immune response so much that it wasn't able to get rid of the virus but it tempered down the immune response," Farber said. "The mice didn't get as sick, they recovered a lot better and the lungs looked a lot healthier."

Orencia and similar drugs would have the added advantage of being effective against different strains of the flu virus because they're targeting the immune system, not the virus. The annual vaccine, on the other hand, is only effective against specific viral strains, the researchers said.

Robert Alaniz is an assistant professor of microbial and molecular pathogenesis at Texas A&M Health Science Center College of Medicine. He said, "Although the paper is a mouse study, the drug used is currently approved for human use and effective in humans. As far as I know, the use of abatacept has not been tested for its effects in humans infected with the flu, which is what makes this study novel and interesting.

"Although the results from this study are intriguing, much more work is warranted to ensure safety in humans infected with seasonal flu. However, the promise of the approach used in this study is that it maintains protective immunity against the virus while reducing disease pathology -- a very important point because overwhelming disease pathology is often a major contributing factor in flu-related deaths," he added.

The U.S. Centers for Disease Control and Prevention has more on influenza.

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From: IRWIN JAMES FRANKEL5/31/2009 9:09:28 PM
2 Recommendations   of 42319
 
St. Louis Fed (nice summary charts):

research.stlouisfed.org

Take a look at pg 18 - commercial paper still collapsing and down about 1/3.

Bank lending resumes decline in latest week:

research.stlouisfed.org

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To: IRWIN JAMES FRANKEL who wrote (31368)5/31/2009 10:08:33 PM
From: Arthur Radley
   of 42319
 
marketwatch.com

Bill Gross(Pimco) has a dim view of the US economy and job market.

IMO the market is due another correction....data this coming week might be the 'straw that breaks the camel's back'. The Texas and local economy has hit a recent roadblock...lay-offs are beginning to hit major oil companies.

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To: kenhott who wrote (31318)6/1/2009 7:36:35 AM
From: kenhott
2 Recommendations   of 42319
 
ASCO 2009--http://www.abstract.asco.org/AbstView_65_33185.html

Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial.

Sub-category: Metastatic Breast Cancer
Category: Breast Cancer--Metastatic Breast Cancer
Meeting: 2009 ASCO Annual Meeting
Citation: J Clin Oncol 27:18s, 2009 (suppl; abstr 3)
Abstract No: 3


Session: Plenary Session including Science of Oncology Award and Lecture
Type: Plenary Presentation
Time: Sunday May 31, 1:00 PM to 4:00 PM
Location: Level 2, West Hall D2

Author(s): J. O'Shaughnessy, C. Osborne, J. Pippen, M. Yoffe, D. Patt, G. Monaghan, C. Rocha, V. Ossovskaya, B. Sherman, C. Bradley; Baylor Sammons, Texas Oncology, US Oncology, Dallas, TX; Cancer Centers of North Carolina/US Oncology, Raleigh, NC; Texas Oncology Cancer Center, US Oncology, Austin, TX; Kansas City Cancer Center, US Oncology, Kansas City, MO; BiPar Sciences, Inc., Brisbane, CA

Abstract:

Background: TNBC is an aggressive breast cancer subtype that shares molecular and pathologic features with BRCA1-related breast cancers. BRCA-deficient cells are sensitive to inhibition of PARP1, a critical enzyme of cell proliferation and DNA repair, and thus represent a rational target of PARP inhibitor-based cancer therapy. The objectives of this study were to evaluate BSI-201, a potent PARP1 inhibitor, in combination with gemcitabine/carboplatin (G/C) in subjects with metastatic TNBC. Methods: Eligible subjects had measurable disease and had =2 prior cytotoxic regimens for ER-, PR-, and HER2-negative metastatic breast cancer. Patients were randomized (1:1) to G/C alone or G/C + BSI-201. Gemcitabine (1000 mg/m2) and carboplatin (AUC=2) were given on days 1 and 8, and BSI-201 (5.6 mg/kg; iv; biweekly) on days 1, 4, 8, and 11 every 21 days. Endpoints were clinical benefit rate (CBR = CR + PR + SD =6 months), progression-free survival (PFS) and overall survival (OS).

Results: Analyses of the first 86 of a planned 120 patients showed that BSI-201 + G/C had improved CBR, median PFS, and median OS, compared with G/C alone. The frequency and nature of adverse events (AEs) did not differ between arms.

Conclusions: This preliminary analysis demonstrates that BSI-201 + G/C significantly improves CBR, PFS, and OS, compared with G/C alone. BSI-201 + G/C was well tolerated, with BSI-201 adding no significant toxicity to G/C. Updated CBR, PFS, and OS for all 120 patients and exploratory correlative analyses of PARP expression and clinical response will be presented.

G/C (n = 44) G/C+BSI-201 (n = 42) Hazard ratio (95% CI) P value
=======================================================
CBR, % 12 52 0.0012
Median PFS, days 87 211 0.30 (0.15-0.59) 0.0003
Median OS, days 169 >254 0.24 (0.09-0.61) 0.0012

++++++++++++++++++++++++++++
The table didn't copy well. But compared to G/C base therapy, drug had Clinical Benefit Rate (CR + PR + SD =6 months) of 52% vs. 12%. PFS 211 days vs. 87 days. Med OS of >254 days vs. 169 days.

All the PARP inhibitors that I know of have been taken out by big pharm. Last I counted, there were like 6 in development.

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To: Arthur Radley who wrote (31369)6/1/2009 7:42:32 AM
From: kenhott
1 Recommendation   of 42319
 
OT- Govt is in the "do ANYTHING" mode. I would keep an eye on the bond market, currency market, behaviorial events, etc. to show us what clues to stock directions.

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