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Most people assume Provenge then chemo, for example. But the best chemo/immuno data I've seen suggest it is better to give immuonablative chemo first to "reset" the immune system, and THEN give the immune training immuno drug.
Being a consultant for BMY didn't stop Prof. Eggermont from stressing the autoimmune toxicities of anti-CTLA4 agents (and the danger to patients with clinical or subclinical autoimmune disease), at the 11th World Congress on Cancers of the Skin. Btw, he was the lead investigator of the EORTC's ganglioside GM2-KLH vaccine failed (has been halted early) trial in melanoma.
A Vision for Personalized Medicine
http://www.technologyreview.com/biomedicine/24703/
Genomics pioneer Leroy Hood [my favorite guru] says a coming revolution in medicine will bring enormous new opportunities.
By Emily Singer, Tuesday, March 09, 2010
Leroy Hood has been at the center of a number of paradigm shifts in biology. He helped to invent the first automated DNA sequencing machine in the 1980s, along with several other technologies that have changed the face of molecular biology. And in 2000, he founded the Institute for Systems Biology, a multidisciplinary institute in Seattle dedicated to examining the interactions between biological information at many different levels, and to moving forward a new perspective for studying biology. The next revolution he plans to help shape is in medicine, using new technologies and new knowledge in biology and informatics to make its practice more predictive, preventative and personal.
Hood says that with each of the major transitions he's been a part of, he has faced skepticism. The human genome project, for example, had many naysayers. But he says the best way to overcome doubts is with results. To that end, Hood has founded a startup called Integrated Diagnostics, which is developing cheap diagnostics that could be used to detect diseases at earlier, more treatable stages. He has also developed a partnership between the Institute for Systems Biology and Ohio State Medical School, where he hopes to show how combining existing medical and genomics technologies can affect the practice of health care today.
Hood contends that digitizing medical records--the health-care industry's major push at the moment--is just one small part of the informatics overhaul the field needs to undergo. And pharmacogenomics--the practice of using an individual's genetic makeup to choose drugs --provides only a limited example of the potential power of personalized medicine.
TR: How do you see the future of personalized medicine?
LH: I think personalized medicine is too narrow a view of what's coming. I think we'll see a shift from reactive medicine to proactive medicine. I define it as "P4" medicine--powerfully predictive, personalized, preventative--meaning we'll shift the focus to wellness--and participatory. That means persuading the various constituencies that this medicine is real and it's here. Physicians will have to learn a medicine they didn't learn in medical school.
TR: What new technologies will drive the revolution in medicine?
LH: Individual genomes will become a standard of medical records in 10 years or so, and we will have the power to make inferences [about an individual's health] when combined with phenotypic information. Then we can begin to plan strategies for individual health care in ways we have never done before.
Nanotechnology approaches to protein measurement--such as measuring 2,500 proteins from a drop of blood--will also be important. We want to develop tests to asses 50 organ-specific proteins from 50 organs as way of interrogating health rather than disease.
The third technology that is going to be transformational is the ability to get detailed analysis from a single cell. We can analyze transcriptomes and RNAomes, proteomes and metabolomes [the collection of transcribed genes or messenger RNA, total RNA, proteins and metabolites, respectively, in the cell]. That information will reveal quanti cellular states that will say lots about normal mechanisms and disease mechanisms. For example, we are doing an experiment now where we take 1,000 cells from glioblastomas [a type of brain tumor] and select transcripts from each of those cells. We're discovering interesting new things about what constitutes a tumor.
The final driver is going to be what I generally call computational and mathematical tools, the ability to deal with data dimensionality that is utterly staggering. If we have patients in 10 years with billions of data points, being able to compare that with individual genotype-phenotype correlations will give us deep and fundamental new insights into predictive medicine. But the challenge is, where will we get the cycles to make those computations and where will we get storage for all this data?
TR: So IT has a major role to play in personalized medicine?
LH: Medicine is going to become an information science. The whole health-care system requires a level of IT that goes beyond mere digitization of medical records, which is what most people are talking about now. In 10 years or so, we may have billions of data points on each individual, and the real challenge will be to develop information technology that can reduce that to real hypotheses about that individual.
TR: Will there be consequences beyond medicine?
LH: I think the P4 medicine revolution has two enormous societal consequences. It will absolutely transform the business plans of every sector of health care. Which will adapt and which will become dinosaurs? That's an interesting question, but it will mean enormous opportunities for companies.
I also think it will lead to digitization of medicine, the ability to get relevant data on a patient from a single molecule, a single cell. I think this digitization in the long run will have exactly the same consequences it has had for the digitization of information technology. In time, the costs of health care will drop to the point where we can export it to the developing world. That concept, which was utterly inconceivable a few years ago, is an exciting one.
TR: What will be the challenges in implementing this vision of medicine?
LH: I think the biggest challenges will be societal acceptance of the revolution. We are putting together something we call the P4 Medical Institute. The idea is to bring in industrial partners as part of this consortium to help us transfer P4 medicine to the patient population at Ohio State University, which is both the payer and provider for its employees. We plan to announce further details of this project in two or three months.
Hurvitz resigned from Teva as well #msg-47618067
Teva Pharmaceuticals names Phillip Frost as new chairman
http://www.globes.co.il/serveen/globes/docview.asp?did=1000545297&fid=942
Dr. Phillip Frost, the largest private investor in Teva, replaces company founder Eli Hurvitz.
Shiri Habib-Valdhorn, Adi Ben-Israel and Ran Rimon9 Mar 10 15:13
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) has appointed Dr. Phillip Frost as chairman, replacing Eli Hurvitz.
Commenting on his appointment, Dr. Frost said: “We are all saddened by the circumstances that have caused this development. We are all keenly aware of the unique role Eli Hurvitz has played for so long in Teva’s development, and I am sure that all the members of the Board and all Teva's employees join me in wishing Eli a speedy and full recovery.”
In response to reports that he planned moving Teva's headquarters to the US, he added, "I fully support our commitment to leadership in the global generics market from our headquarters in Israel. It would not occur to me to move the headquarters from Israel. It's absolute nonsense. There would be no logic to it. Things are managed well enough as it is. Teva is one of Israel's natural resources and it benefits from the company.”
Frost, 73, is the largest single private shareholder in Teva with a 1.6% stake. He was CEO of IVAX, a generic pharmaceutical company acquired by Teva for $7.4 billion in 2005. Last year Frost sold 1.4 million Teva shares for an estimated $70 million.
Three weeks ago Teva announced that Hurvitz was taking temporary sick leave. However, it is now believed that his illness will not allow him to return to his post.
Hurvitz founded Teva and has built it into the world's largest generic pharmaceutical manufacturer. He served as its CEO for many years before becoming chairman. Hurvitz has also served as president of the Manufacturers' Association of Israel and as chairman of Bank Leumi (TASE:LUMI).
The board of directors also unanimously appointed Prof. Moshe Many as vice chairman. He has served as acting chairman over the past three weeks while Hurvitz was on sick leave.
Teva's share fell 1.76% in late afternoon trading on the TASE today to NIS 228.30. The share closed at $60.49 on Nasdaq yesterday, giving a market cap of $53.53 billion.
I think so but rkrw or Dew should know better.
ITMN/pirfenidone panel:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM203076.pdf
Are there any IPF specialists in the crowd? Oddly not.
"Conclusions: These data favor 10 mg/kg as the optimal dose. 0.3 mg/kg appears to be clinically ineffective."
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=55&abstractID=35387
The 10mg/kg dose is likely more effective but there's a higher rate of side effects.
Recentin (cediranib) did not meet primary endpoint in Horizon III study in metastatic colorectal cancer
AstraZeneca's Recentin fails trial, hurts shares
http://www.reuters.com/article/idUSTRE6272NO20100308?type=globalMarketsNews
Kate Kelland LONDON Mon Mar 8, 2010 5:25am EST
LONDON (Reuters) - AstraZeneca's cancer drug Recentin failed in a head to head late stage trial with Roche's
Avastin in colorectal cancer patients, hurting the Anglo-Swedish drugmaker's shares on Monday.
The company said the data, which analysts had expected to be negative for Recentin, showed the experimental drug did not meet its primary endpoint in the Horizon phase III study.
But it said it would wait for fresh data from a second late stage trial before making any decisions on filing the drug for approval.
AstraZeneca shares lost more than 1.7 percent to trade around 29.42 at 1006 GMT. Roche shares were down 0.5 percent.
"While we recognized that challenging Avastin would be a high hurdle, it is still disappointing, despite evidence of clinical activity with Recentin, not to have met the primary endpoint in this study," Astra's head of oncology Alan Barge said in a statement.
Recentin, a pill, was developed to challenge Roche's injectable treatment Avastin. Both are targeted therapies designed to starve tumors by stopping them from building blood vessels, a process called anti-angiogenesis.
Analysts see Recentin reaching sales of around $329 million by 2013, according to Thomson Pharma consensus forecasts.
Morgan Stanley analysts said they saw a around a 2 percent downside risk to consensus forecasts for Astra's earnings per share in 2014.
They said an upcoming U.S. ruling on a patent challenge to Astra's cholesterol-lowering drug Crestor -- the firm's most crucial sales driver -- was "the next critical catalyst" for the stock, and were "cautiously optimistic" on that.
A verdict on Crestor trial is expected from Delaware district court before the end of July, when the judge in the case is due to retire.
Panmure Gordon analysts said they expected AstraZeneca's stock to come under pressure but added in a note: "We advocate buying on weakness as the mid-term guidance story remains intact, because Recentin was a high risk development."
MORE RECENTIN DATA TO COME
Astra, which reaffirmed its financial guidance for 2010, said Horizon III was the first of "two pivotal studies" of Recentin, known generically as cediranib, in colorectal cancer.
The other study, Horizon II, is testing Recentin combined with chemotherapy against chemotherapy alone, and data are expected in the coming months.
Barge said the results of this trial would offer "further information on whether Recentin may provide benefit for patients with colorectal cancer and will inform any decision about possible regulatory filings."
Ambrian analysts Mike Ward and Paul Diggle said in a note that they expected "a positive outcome for Horizon II."
In January, AstraZeneca forecast of revenues of $28 billion to $34 billion over 2010 to 2014, including $4 billion to $6 billion of revenues from new drugs, pipeline products and licensing deals..
Last month the first raised its earnings per share forecast for 2010 to a range of $5.90 to $6.30 after settling a tax dispute in Britain.
Results of a separate late stage trial with Recentin in treating recurrent glioblastoma brain tumors are also expected in the first half of this year. Initial data showed it helped stop the fluid build-up caused by glioblastoma and helped mice with the brain tumors live longer.
In the trial you cited of ipilimumab+MDX-1106, there's also one arm testing ipilimumab at 3 mg/kg. This lower dose was thought to be enough in combination and was also tested with the vaccine (MDX-1379), but I assume that with accumulating data, it looks like the 10mg/Kg dose is better and AEs (especially diarrhea) can be manageable. I am not bearish at all and think the presentation at ASCO will show positive data. Will be interesting to see if this trial in HLA-A*0201 positive petients will increase RR but we'll have to wait for all phase III data.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed February's entries; Added: AAAOS, ASCPT, SG-CAP, ASCMID, AAN, NKF, AACE, AACR, WVCDC, ISHLT, ICAR, AANS, AATS
MARCH 2010
Society of Surgical Oncology - SSO
St. Louis, MO
March 4-7, 2010
http://www.surgonc.org/
American Academy of Dermatology - AAD
Miami, FL
March 5-9, 2010
http://www.aad.org/
American Academy of Orthopedic Surgeons - AAAOS
New Orleans, LA
March 9-13, 2010
http://www.aaos.org/
Society of Interventional Radiology - SIR
Tampa, Fl
March 13-18, 2010
http://www.sirweb.org/
American College of Cardiology - ACC
Atlanta, GA
March 14-16, 2010
http://acc.org/
Society of Gynecological Oncologists - SGO
San Francisco, CA
March 14-17, 2010
http://www.sgo.org/
American Society for Clinical Pharmacology & Therapeutics - ASCPT
Atlanta, GA
March 17-20, 2010
http://ascpt.org/
International Conference Primary Therapy of Early Breast Cancer - SG-CAP
St Gallen, Switzerland
March 18-20, 2010
http://www.oncoconferences.ch/
American College of Medical Genetics - ACMG
Albuquerque, New Mexico
March 24-28, 2010
http://www.acmgmeeting.net/
APRIL 2010
European Congress on Clinical Microbiology and Infectious Diseases - ASCMID
Vienna, Austria
April 10-13, 2010
http://www.escmid.org/
American Academy of Neurology - AAN
Toronto, Canada
April 10–17
http://www.aan.com/
National Kidney Foundation - NKF
Orlando, FL
April 13-17, 2010
http://www.kidney.org/news/meetings.cfm
European Association for the Study of the Liver - EASL
Vienna, Austria
April 14-18, 2010
http://www.easl.eu/
American Association for Cancer Research - AACR
Washington, D.C.
April 17-21, 2010
http://www.aacr.org/
American Association of Clinical Endocrinologists - AACE
Boston, MA
April 21–25, 2010
http://www.aace.com/meetings/ams/2010/
World Vaccine Congress - WVCDC
Washington, D.C.
April 19-22, 2010
http://www.terrapinn.com/2010/wvcdc/index.stm
International Society for Heart and Lung Transplantation - ISHLT
Chicago, IL
April 21-24, 2010
http://www.ishlt.org/
International Conference on Antiviral Research - ICAR
San Francisco, CA
April 25-28, 2010
http://isar.phrm.cf.ac.uk/
MAY 2010
American Association of Neurological Surgeons - AANS
Philadelphia, PA
May 1-5, 2010
http://www.aans.org/
Digestive Disease Week - DDW
New Orleans, LA
May 1-5, 2010
http://www.ddw.org/
Society of Thoracic Surgeons - AATS
Toronto, ON, Canada
May 1 - 5, 2010
http://www.aats.org/annualmeeting/
American Thoracic Society - ATS
New Orleans, LA
May 14-19, 2010
http://conference.thoracic.org/
JUNE 2010
European Society of Human Genetics - ESHG
Gothenburg, Sweden
June 12-15, 2010
https://www.eshg.org/
OCTOBER 2010
American Association for the Study of Liver Diseases - AASLD
Boston, Massachusetts
October 29 - November 2, 2010
http://www.aasld.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
----
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BTW, what's PD-1? TIA
The Chinese will probably use it mostly internally and in neighboring countries and MON can sue of course, but I doubth that will change much.
Exactly, and they have to feed 1.3B mouths!
I would keep PLX4032 (R7204), a BRAF inhibitor on my list.
You're right, I should have written - Treanda will likely have market exclusivity at least until Mar 2013.
Response could be better/higher among HLA-A*0201 positive patients when ipilimumab is combined with MDX-1379. Data from that 2nd line phase III will be presented at ASCO.
Was this from the monotherapy treatment or ipilimumab+peptide vaccine (MDX-1379) or with Dacarbazine and was it the 10mg/Kg dose of ipli?
Note that J&J/Bayer's Xarelto (Rivaroxaban) RECORD -1,2, & 3 (hip and knee) studies, in which Xarelto showed superiority over Lovenox, were head-to-head with Lovenox 40mg QD, while RECORD-4 (after total knee replacement operation) was vs. Lovenox 30mg BID.
http://clinicaltrials.gov/ct2/show/NCT00362232?term=NCT00362232&rank=1
This one on statistical analysis issues is for you Clark
We're so good at medical studies that most of them are wrong
http://arstechnica.com/science/news/2010/03/were-so-good-at-medical-studies-that-most-of-them-are-wrong.ars
By John Timmer | Last updated a day ago
It's possible to get the mental equivalent of whiplash from the latest medical findings, as risk factors are identified one year and exonerated the next. According to a panel at the American Association for the Advancement of Science, this isn't a failure of medical research; it's a failure of statistics, and one that is becoming more common in fields ranging from genomics to astronomy. The problem is that our statistical tools for evaluating the probability of error haven't kept pace with our own successes, in the form of our ability to obtain massive data sets and perform multiple tests on them. Even given a low tolerance for error, the sheer number of tests performed ensures that some of them will produce erroneous results at random.
The panel consisted of Suresh Moolgavkar from the University of Washington, Berkeley's Juliet P. Shaffer, and Stanley Young from the National Institute of Statistical Sciences. The three gave talks that partially overlapped, at least when it came to describing the problem, so it's most informative to tackle the session at once, rather than by speaker.
Why we can't trust most medical studies
Statistical validation of results, as Shaffer described it, simply involves testing the null hypothesis: that the pattern you detect in your data occurs at random. If you can reject the null hypothesis—and science and medicine have settled on rejecting it when there's only a five percent or less chance that it occurred at random—then you accept that your actual finding is significant.
The problem now is that we're rapidly expanding our ability to do tests. Various speakers pointed to data sources as diverse as gene expression chips and the Sloan Digital Sky Survey, which provide tens of thousands of individual data points to analyze. At the same time, the growth of computing power has meant that we can ask many questions of these large data sets at once, and each one of these tests increases the prospects than an error will occur in a study; as Shaffer put it, "every decision increases your error prospects." She pointed out that dividing data into subgroups, which can often identify susceptible subpopulations, is also a decision, and increases the chances of a spurious error. Smaller populations are also more prone to random associations.
In the end, Young noted, by the time you reach 61 tests, there's a 95 percent chance that you'll get a significant result at random. And, let's face it—researchers want to see a significant result, so there's a strong, unintentional bias towards trying different tests until something pops out.
Young went on to describe a study, published in JAMA, that was a multiple testing train wreck: exposures to 275 chemicals were considered, 32 health outcomes were tracked, and 10 demographic variables were used as controls. That was about 8,800 different tests, and as many as 9 million ways of looking at the data once the demographics were considered.
The problem with models
Both Young and Moolgavkar then discussed the challenges of building a statistical model. Young focused on how the models are intended to help eliminate bias. Items like demographic information often correlate with risks of specific health outcomes, and researchers need to adjust for those when attempting to identify the residual risk associated with any other factors. As Young pointed out, however, you're never going to know all the possible risk factors, so there will always be error that ends up getting lumped in with whatever you're testing.
Moolgavkar pointed out a different challenge related to building the statistical models: even the same factor can be accounted for using different mathematical means. The models also make decisions on how best handle things like measuring exposures or health outcomes. The net result is that two models can be fed an identical dataset, and still produce a different answer.
At this point, Moolgavkar veered into precisely the issues we covered in our recent story on scientific reproducibility: if you don't have access to the models themselves, you won't be able to find out why they produce different answers, and you won't fully appreciate the science behind what you're seeing.
Consequences and solutions
It's pretty obvious that these factors create a host of potential problems, but Young provided the best measure of where the field stands. In a survey of the recent literature, he found that 95 percent of the results of observational studies on human health had failed replication when tested using a rigorous, double blind trial. So, how do we fix this?
The consensus seems to be that we simply can't rely on the researchers to do it. As Shaffer noted, experimentalists who produce the raw data want it to generate results, and the statisticians do what they can to help them find them. The problems with this are well recognized within the statistics community, but they're loath to engage in the sort of self-criticism that could make a difference. (The attitude, as Young described it, is "We're both living in glass houses, we both have bricks.")
Shaffer described how there were tools (the "family-wise error rate") that were once used for large studies, but they were so stringent that researchers couldn't use them and claim much in the way of positive results. The statistics community started working on developing alternatives about 15 years ago but, despite a few promising ideas, none of them gained significant traction within the community.
Both Moolgavkar and Young argued that the impetus for change had to come from funding agencies and the journals in which the results are published. These are the only groups that are in a position to force some corrections, such as compelling researchers to share both data sets and the code for statistical models.
Moolgavkar also made a forceful argument that journal editors and reviewers needed to hold studies to a minimal standard of biological plausibility. Focusing on studies of the health risks posed by particulates, he described studies that indicated the particulates in a city were as harmful as smoking 40 cigarettes daily; another concluded that particulates had a significant protective effect when it comes to cardiovascular disease. "Nobody is going to tell you that, for your health, you should go out and run behind a diesel bus," Moolgavkar said. "How did this get past the reviewers?"
But, in the mean time, Shaffer seemed to suggest that we simply have to recognize the problem and communicate it with the public, so that people don't leap to health conclusions each time a new population study gets published. Medical researchers recognize the value of replication, and they don't start writing prescriptions based on the latest gene expression study—they wait for the individual genes to be validated. As we wait for any sort of reform to arrive, caution, and explaining to the public the reasons for this caution, seems like the best we can do.
ADVANCE-1, the study that failed, used 30mg qD of subcutaneous Lovenox
UK cost body spurns Celgene rare blood cancer drug
http://www.reuters.com/article/idCNLDE6230H220100304?rpc=44
LONDON, March 4 (Reuters) - Britain's healthcare cost agency has recommended that Celgene's (CELG.O) drug Vidaza, or azacitidine, should not be used in the state-run health service to treat a rare blood cancer because it is too expensive.
Celgene said on Thursday it would appeal against the negative recommendation by the National Institute for Health and Clinical Excellence (NICE).
Its drug is used to treat myelodysplastic syndromes (MDS), a group of bone marrow disorders where the marrow doesn't produce enough of one or more types of blood cells.
Carole Longson, health technology evaluation centre director at NICE, said that, relative to the benefits, the price of around 45,000 pounds ($68,000) a year was "too high for it to be recommended as a cost effective use of NHS (National Health Service) resources".
The drug is approved and reimbursed in more than 30 other countries around the world.
The NICE draft decision is open to appeal and further consultation before final guidance is issued, which the agency said was expected in May. (Reporting by Ben Hirschler, editing by Will Waterman) ($1=.6640 POUND)
PTC/GENZ:
Good thing besides they are still private - the drug is apparently safe and didn't alter 'normal' stop codons, which would result in off target AE. I would like to have answers to open questions such as:
Did full-length dystrophin appear in the muscles of the treated individuals?
Was the treatment more effective in individuals with the nonsense mutation TGA than TAA or TAG?
A lot can happen to change efficiency in other conditions: DNA sequence requirements, ribosome modifications, ribosomal protein variants... At this point I'd say that ataluren (PTC124) has a less reasonable chance to show meaningful physiological impact in nmDBMD without further modifications. However, its ability to promote ribosomal read-through of stop codons, might still show some level of activity that would translate to efficient treatment in other indications.
Pfizer is back in the race. Teva gave its proposal to Ratiopharm last week
http://www.bloomberg.com/apps/news?pid=20601202&sid=aCtyq0Hr4zP0
There were some similar previous cases where the brand manufacturer has de-listed challenged patent and the FDA tried to take Teva's exclusivity and lost at the U.S. Court of Appeals.
There is/was another agent in the MRK-GTXI collaborated SARMs program - MK-0773. It was not mentioned in MRK's recent pipeline, so I assume the whole program got axed.
Myriad has indicated the launch of 2 new molecular diagnostic products in 2010, so the next one will probably be a pancreatic cancer test (they have mentioned a pancreatic cancer gene they will probably combine with BRCA2 and P16).
Yes, thank you and ghmm (I like his 'you scratch my back, I'll scratch yours' attitude ). I obviously remembered the TF-Null data.
Are you sure the 63% isn't the limit of quantification - less than 40 IU/mL not detection - 15 IU/mL)? I kind of remember it this way but too tired to search.
What percentage of undetectable treatment-naive patiens were in the INFORM-1 after 14 days, 25% or so with the higher doses?
Roger on the “intellectual capital” point.
I don't know much about OSIP's pipeline except it's early but maybe Astellas expects positive results from Tarceva's phase III trial in NSCLC patients with mutations in the TK domain of EGFR or approval in maintenance setting. Only possible counterbidder I can think of is Roche but I don't think it will.
From MRK’s 10-K on the pipeline pruning:
Merck has discontinued internal development of MK-2866 (which is a SARM) under this agreement, and is currently discussing next steps with GTx.
End of the way for narlaprevir (SCH 900518), MK-7009 is the chosen one:
Merck had to choose among similar drugs in two research areas: hepatitis C and cancer. In December, Merck said its hepatitis C drug, MK-7009, also known as vaniprevir, would take priority over a similar drug from Schering.
Study also shows the 11C-PiB PET imaging tech as a monitoring tool for AD diagnostics.
And it looks like Astellas really wants OSIP.
FDA approves Shire's drug for Gaucher disease
http://www.reuters.com/article/idCNN2620418520100226?rpc=44
Astellas Pharma Inc. Offers to Acquire OSI Pharmaceuticals for $52.00 Per Share in Cash
http://finance.yahoo.com/news/Astellas-Pharma-Inc-Offers-to-prnews-334695742.html/print?x=0
Cephalon Exercises its Option to Acquire Ception Therapeutics
http://finance.yahoo.com/news/Cephalon-Exercises-its-Option-prnews-2359689579.html?x=0&.v=1
Ception Delivers Positive Results from a Phase II Study of CINQUIL in Adult Eosinophilic Asthma
Press Release Source: Cephalon, Inc.; Ception Therapeutics, Inc. On Tuesday February 23, 2010, 8:00 am EST
FRAZER, Pa. and MALVERN, Pa., Feb. 23 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:CEPH - News) announced today that it has exercised its option to acquire Ception Therapeutics, Inc., following receipt of positive data from a clinical study in adults with eosinophilic asthma. A Phase II clinical trial of Ception's lead compound, CINQUIL™ (reslizumab), in 106 patients demonstrated improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation, as measured by the primary study endpoint, a change in Asthma-Control -Questionnaire or ACQ score (p=0.054). In addition, an analysis of the FEV1, a measure of lung function, showed a statistically significant improvement with CINQUIL compared to placebo (p= 0.002).
"This study showed a strong treatment signal and compelling internal consistency on the effect of CINQUIL on measurements of asthma and lung function," said Dr. Lesley Russell, Chief Medical Officer at Cephalon. "These data provide confidence that CINQUIL shows a meaningful treatment effect in this patient population. We look forward to advancing CINQUIL into Phase three clinical trials."
Based on these Phase II results, Cephalon exercised its option to acquire Ception on February 22, 2010. Following the exercise of its option, Cephalon's obligation to enter into a merger agreement relating to the acquisition is subject to Cephalon's rights under, and Ception's satisfaction of certain conditions set forth in, the option agreement. The merger agreement is subject to customary closing conditions, including expiration of applicable antitrust waiting periods. Upon the closing of the merger, Cephalon would purchase all of the outstanding capital stock of Ception for $250 million, subject to adjustment for any third party debt held by Ception. Ception shareholders could receive additional payments related to clinical and regulatory milestones.
"The acquisition of Ception is consistent with our strategy to diversify into biologics and provides us with an important Phase three asset for further development," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.
"Today marks an important milestone for Ception, as well as the asthma community," said Stephen Tullman, President and CEO, Ception Therapeutics. "These encouraging results will allow the advancement of this novel therapeutic for the many people suffering from this severe, poorly controlled form of asthma. The Ception team has done an excellent job, and I am extremely thankful for the support provided by Cephalon and our investors."
About the Study
The four-month, double-blind, placebo-controlled Phase II clinical trial assessed the efficacy and safety of CINQUIL in the treatment of patients with poorly controlled eosinophilic asthma. In this study, 106 adults patients received CINQUIL (3mg/kg) or placebo administered intravenously once every 28 days for four cycles. Patients entering the study were required to have persistent asthma symptoms, despite high doses of inhaled corticosteroids, and elevated eosinophils in their sputum. The primary study endpoint was improvement in asthma control as assessed by the change in Asthma-Control-Questionnaire (ACQ) score at week 15. Patients on CINQUIL showed an improvement on the ACQ compared to placebo (p=0.054). In this clinical study, CINQUIL was generally well tolerated with an adverse event profile comparable to placebo. The most commonly observed side effect associated with CINQUIL versus placebo was nasopharyngitis.
Secondary endpoints and analysis of a subgroup of patients in the study showed the following:
* A significant reduction in sputum eosinophil counts for CINQUIL compared to placebo (p=0.006)
* A significant improvement in FEV1 and FVC for CINQUIL compared to placebo (p=0.002 and 0.004 respectively). FEV1 and FVC are indices for assessing airway obstruction, bronchoconstriction or bronchodilation
* In a subset of patients with both asthma and nasal polyps (n= 38), patients on CINQUIL compared to placebo showed a significant mean improvement in ACQ (p=0.011) and FEV1 (p=0.046)
* Fewer patients on CINQUIL compared to placebo experienced clinical asthma exacerbations. Clinical asthma exacerbations were defined as a 20 percent decrease in FEV1 from baseline, emergency treatment or hospital admission and treatment for three or more days of oral corticosteroids
Cephalon will further evaluate the study data and work with the FDA to determine the necessary and appropriate steps to move clinical development of CINQUIL forward to Phase III.
About CINQUIL
CINQUIL is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, which are inflammatory white blood cells implicated in a number of allergic diseases including asthma. This investigational agent is currently administered as an intravenous injection; a subcutaneous formulation is being developed.