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Lilly drops Alimta in head/neck cancer, test fails
http://www.reuters.com/article/idCNLDE69A0UO20101011?rpc=44
Merck KGaA says will appeal to EU agency on cladribine:
http://www.reuters.com/article/idCNLDE69A06420101011?rpc=44
Gelesis/Attiva capsule for obesity
Preclinical study, so way too early but was found to work in rats - reduced food intake:
http://www.gelesis.com/news/gelesis-presents-mechanistic-data-supporting-its-novel-clinical-stage-obesity-treatment-at-obesity-2010-49/
Novartis's Afinitor Fails to Slow Rare Form of Pancreatic Cancer in Trial
http://www.bloomberg.com/news/2010-10-11/novartis-s-afinitor-fails-to-slow-rare-form-of-pancreatic-cancer-in-trial.html
By Eva von Schaper - Oct 11, 2010
Novartis AG’s Afinitor kidney cancer drug didn’t slow a rare form of pancreatic cancer in a late- stage trial, researchers said.
Afinitor combined with the company’s Sandostatin drug failed to stop neuroendocrine tumors, or NET, from growing, Basel, Switzerland-based Novartis said in an e-mailed statement today. The research was presented at the European Society for Medical Oncology meeting today in Milan.
Afinitor is approved as a treatment for patients with advanced kidney cancer who aren’t helped by standard therapies. The drug works by blocking mTOR, a cell messenger that controls cell growth and reproduction.
“A key goal of treating patients with advanced NET is to extend time without tumor growth,” Marianne Pavel, a professor of medicine at the Charité Hospital in Berlin, said in the release.
The trial, dubbed RADIANT-2, included 429 patients with advanced NET who received either Afinitor or Afinitor plus Sandostatin. The most frequent side effects were stomatitis, rash, fatigue and diarrhea. The drug failed to reach its goal of extending progression-free survival, a common measure of a drug’s efficacy.
The tumors grow in the neuroendocrine system, which consists of cells that have the properties both of nerve cells and of hormone-making cells. The growths can be found throughout the body, according to the American Cancer Society.
Novartis estimates that 5 patients in 100,000 are diagnosed with NET every year.
Another study, RADIANT-3, showed that Afinitor, also known as everolimus, kept advanced pancreatic neuroendocrine tumors at bay for 11 months, more than twice as long as for patients given the best supportive care treatment plus placebo, Novartis said in June. The company plans to seek regulatory approval this year for the use of Afinitor against pancreatic neuroendocrine tumors, Novartis said.
FDA declines approval of Jazz drug for fibromyalgia
http://www.reuters.com/article/idUSSGE69A11M20101011?rpc=401&feedType=RSS&feedName=governmentFilingsNews&rpc=401
Don't know the history/calibration of trials run in India. I see that even big players like AZN were running some schizophrenia trials (sites) there. Yes, psychosis tends to be judged relatively subjectively and differ between countries but I think the PANSS score, which includes 30 items such as delusions, hallucinatory behavior, and anxiety, is quite universal and well established. The question I had in mind is whether Indian patients tend to comply better than American ones to the treatment as they may view trial participation as a way to get improved care.
Re: CYP-1020 trial sites
Of course, I'd feel better if the majority of sites/patients were in the US but I find Dr. Laster to be reliable (otherwise I wouldn't have touched BiolinRx).
Clinical trials of antipsychotic have high dropout rates (it was over 70% in the 18 months CATIE study). The 47% dropout rate in the US group is within the range for this treatment. Also cognitive improvement was found at all sites and as I said in the earlier post, the positive/negative syndrome scale (PANSS) score and side effects were 'norm' for Risperidonein. The number of patients enrolled to extension as well as sites were indeed limited for financial reasons.
One thing that bothered me with regards to the EAGLE trial was that only 2 sites were located in the US (see slide below). I asked the CEO at the time (Dr. Laster) and the reason he gave was as expected - cost. However, he also told me later that the data were similar in terms of response, efficacy and AE for different sites and historical data of Risperidone.
The new info I have on Procognia/Teva relations has nothing to do with Lovenox. It's a long story but bottom line hasn't changed and Procognia shifted to cancer diagnostics since.
ROSG - not following closely, just saw this (and then looked at their Q2 revenues to see that their three commercial tests aren't big sellers. Perhaps insurance companies will not yet pay for them):
Rosetta Genomics cuts 20 pct workforce
http://www.reuters.com/article/idCNSGE6940IW20101005?rpc=44
Tue Oct 5, 2010 9:53am EDT
* Says cutting 14 jobs
* Restructuring to reduce expenses by about $4 mln annually
* Says has cash flow to fund operations through March 2011
Oct 5 (Reuters) - Israel-based Rosetta Genomics Ltd (ROSG.O) said it was cutting 14 jobs, or 20 percent of its workforce, but had enough cash flow to fund operations through March 2011.
The molecular diagnostics company said all employees will also move to a four-day work week with a 20 percent cut in their salary.
The restructuring would result in reducing annual operating expenses by about $4 million and the full impact would go into effect by early December 2010, the company said in a statement.
In 2009, the company incurred annual operating expenses of about $14 million.
The jobs cuts were mainly in the research and development and general and administrative divisions.
Rosetta Genomics also said the move was not expected to affect planned launches of their second generation of diagnostic tests or significantly change plans for their third generation of diagnostic products currently in discovery.
The company's shares, which have fallen 45 percent in the last six months, closed at $1.20 Monday on Nasdaq.
Obviously, one may find weak points in almost every study like I did for Gotzsche and Johansen provocative review posted by Dew (#msg-52075086). I have posted the Stockley et al work to show the other side of the debate on augmentation therapy in alfa-1 antitrypsin deficiency. Bear in mind that all three sponsors of U.S. licensed Alpha-1-PI products have been asked to conduct post-marketing studies to help evaluate efficacy in terms of clinically meaningful endpoints directly related to emphysema. I think these placebo controlled trials focusing on lung CT scanning as an endpoint are important (because it might be a much better way of looking at efficacy in patient who have Alpha-1-antitrypsin deficiency), even if the sponsor is Talecris or CSL Behring and btw, the authors/investigators of all studies stated these relations so the possible conflicts of interest is well understood.
Analysis of data from 2 trials shows clinical effectiveness of AAT augmentation therapy:
Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed tomography densitometry
http://respiratory-research.com/content/11/1/136
Robert A Stockley et al. Published: 5 October 2010
Background
Two randomised, double-blind, placebo-controlled trials have investigated the efficacy of IV alpha-1 antitrypsin (AAT) augmentation therapy on emphysema progression using CT densitometry.
Methods
Data from these similar trials, a 2-center Danish-Dutch study (n = 54) and the 3-center EXAcerbations and CT scan as Lung Endpoints (EXACTLE) study (n = 65), were pooled to increase the statistical power. The change in 15th percentile of lung density (PD15) measured by CT scan was obtained from both trials. All subjects had 1 CT scan at baseline and at least 1 CT scan after treatment. Densitometric data from 119 patients (AAT [Alfalastin or Prolastin], n = 60; placebo, n = 59) were analysed by a statistical/endpoint analysis method. To adjust for lung volume, volume correction was made by including the change in log-transformed total lung volume as a covariate in the statistical model.
Results
Mean follow-up was approximately 2.5 years. The mean change in lung density from baseline to last CT scan was -4.082 g/L for AAT and -6.379 g/L for placebo with a treatment difference of 2.297 (95% CI, 0.669 to 3.926; p = 0.006). The corresponding annual declines were -1.73 and -2.74 g/L/yr, respectively.
Conclusions
The overall results of the combined analysis of 2 separate trials of comparable design, and the only 2 controlled clinical trials completed to date, has confirmed that IV AAT augmentation therapy significantly reduces the decline in lung density and may therefore reduce the future risk of mortality in patients with AAT deficiency-related emphysema. Trial registration: The EXACTLE study was registered in ClinicalTrials.gov as 'Antitrypsin (AAT) to Treat Emphysema in AAT-Deficient Patients'; ClinicalTrials.gov Identifier: NCT00263887.
The complete article is available as a provisional PDF. The fully formatted PDF and HTML
Do you know how approval in Israel is determined?
Warner Chilcott U.K. Ltd is withdrawinf its application for an extension of indication for Intrinsa (testosterone) transdermal patch to include the treatment of hypoactive sexual desire disorder in menopausal women, due to commercial considerations.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201009290947dowjonesdjonline000354&title=warner-chilcott-pulls-intrinsa-extension-of-indication-application-ema
Just note that Teva and Amgen are still in litigation over patents running until end of 2013.
On MYGN/BRCA patent war
Surrendering a Gene Patent: An International Twist in Myriad Debate
Posted by Dan Vorhaus and John Conley on September 29, 2010
http://www.genomicslawreport.com/index.php/2010/09/29/surrendering-a-gene-patent-an-international-twist-in-myriad-debate/
Several months ago we reported that a group of Australian plaintiffs had initiated litigation challenging the validity of Myriad’s Australian BRCA patents. Much like its U.S. counterpart, the Australian lawsuit represents a frontal attack on the patentability of genes.
Here in the U.S., the gene patent litigation shows no signs of reaching a swift resolution. Over the summer, Myriad appealed March’s widely-discussed district court ruling invalidating several of its key BRCA patents and claims, and the current appeal is unlikely to be the last, regardless of the outcome. In Australia, however, Myriad appears to be taking a different tack: offering to surrender its BRCA patent.
An Offer to Surrender. The development was first reported by the Australian news program Four Corners, which earlier this month ran a program (transcript) on the gene patenting debate and its impact on the availability of genetic testing in Australia. The program concluded with the following:
Three weeks ago, lawyers acting on behalf of Myriad offered to surrender ownership of its Australian breast cancer patent. In a letter obtained by Four Corners, the company stated:
‘Myriad wishes to gift Australian Patent No 686004 [the ‘004 Patent] to the people of Australia.’
Myriad’s critics argue it’s a cynical ploy to kill of [sic] any legal challenge in Australia which could bolster the New York court decision.
Significantly the company pointed out:
‘Myriad’s offer does not constitute an admission that the [‘004 Patent] is invalid.’
In the twists and turns of the genes war, the battle is far from over.
While the GLR has been unable to locate a complete copy of the letter, Myriad has filed with the Australian Official Journal of Patents an “offer to surrender” the ‘004 Patent, which claims “in vivo mutations and polymorphisms in the 17q-linked breast and ovarian susceptibility gene” (pdf).
The main claims in the ‘004 Patent (.pdf) largely track those of Myriads’ BRCA-1 patents that are at the core of the U.S. litigation. The primary difference is that the Australian patent’s claims are not directed at the normal BRCA-1 gene, but at a set of “bad” mutant or polymorphic versions of that gene. Despite this difference, the Australian claims still appear to be valuable for purposes of BRCA diagnostic testing.
Will Myriad’s Surrender be Accepted? Pursuant to Chapter 12, Section 137 of the Australian Patent Act, the Commissioner of Patents may accept an offer to surrender a patent from a patentee (i) “after hearing from all interested persons who…wish to be heard” regarding the proposed matter and, (ii) “where relevant proceedings in relation to a patent are pending,” only with “either the leave of the court or the consent of the parties to the proceedings.”
As in the U.S., the Australian litigation is being positioned by the plaintiffs as an opportunity to argue that genes, including the BRCA genes, are “not an invention capable of patent protection.” With the plaintiffs taking the position in the press that patenting genes is “morally wrong,” it seems reasonably likely that the plaintiffs might object to Myriad’s patent surrender, at least to the extent it moots some or all of their claims.
What about the Rest of Myriad’s Portfolio? Given that Myriad’s notice of surrender refers solely to the ‘004 Patent, the Australian litigation may go forward irrespective of whether Myriad’s surrender is successful. The company is also listed as either the sole patentee or a co-patentee on several related patents, including patents for a “method for diagnosing a predisposition for breast and ovarian cancer” (pdf) or for a “17q-linked breast and ovarian cancer susceptibility gene” (pdf).
These patents bear substantial similarities to those at issue in the U.S. litigation, and it is unclear – and seemingly doubtful – whether the surrender of the ‘004 Patent would materially impair Myriad’s (or its licensee’s) ability to control the market for BRCA testing in Australia.
What Happened to GTL? As we discussed in our earlier post, in 2002 Myriad granted an exclusive license to perform diagnostic testing in Australia and New Zealand of the BRCA-1 and BRCA-2 genes to Genetic Technologies Limited (“GTL”). (We note that GTL is not identified as a licensee of the ‘004 Patent or of the other breast cancer-related patents identified in the IP Australia database, although GTL has publicly discussed its exclusive license.)
According to reports, when GTL first licensed the BRCA intellectual property from Myriad, the company announced that it would refrain from enforcing its rights as a “gift to the people of Australia and New Zealand.” GTL briefly changed that policy in 2008, announcing a “commercial decision to enforce the rights granted to it under an exclusive license from Myriad.” GTL sent warning letters to government testing letters around Australia, only to quickly back off in response to substantial public outcry.
But as Myriad attempts to gift at least one of its BRCA patents back to the people of Australia and New Zealand, what are GTL’s rights and what, if anything, does it think of Myriad’s decision?
In a very brief op-ed earlier this year in The Australian, GTL’s CEO, Paul MacLeman, clarified that, contrary to popular belief:
In fact, [GTL] would materially benefit from any scaling back of genetic patent rights in this area, as we are the only entity paying for the right to use it even though the test is quite widely used.”
In light of this, it is possible that GTL and Myriad have taken steps to terminate the BRCA license. Or it may be that the license never applied to the ‘004 Patent at all.
Both scenarios are pure speculation, and neither explain Myriad’s apparent decision to pull back on only a portion of its Australian patent portfolio. For the moment, we do not know nearly enough about the rationale behind Myriad’s decision to attempt to surrender the ‘004 Patent while retaining its other patents.
What Does this Mean for Myriad in the U.S.? The simple answer is very little, particularly for the moment. As we wrote when the Australian litigation was first announced, the status of Myriad’s or any other party’s Australian patents is unlikely to have any direct bearing on the validity of Myriad’s U.S. patents. There has been some speculation, including by Four Corners, that Myriad’s patent surrender is a defensive gesture meant to “kill of [sic] any legal challenge in Australia which could bolster the [U.S. district court ruling].” However, given the differences in Australian and U.S. patent law, as well as the likelihood that the Australian litigation will proceed despite Myriad’s attempted surrender of the ‘004 Patent, this seems an unlikely – and at any rate, likely unsuccessful – strategy for Myriad to pursue.
Still, the Myriad gene patent litigation is about more than any specific set of patents or claims. It is an attempt, particularly by the plaintiffs in both the U.S. and Australia, to put the patentability of genetic information and associations on trial in the court of public opinion as well as in the courtroom. So perhaps Myriad’s decision is nothing more than a somewhat puzzling attempt at public relations maneuvering.
As we wrote in June when the Australian litigation was first announced:
…the new Australian case will be, at a minimum, a chance for that country to engage in a public debate over the wisdom and legality of patenting genes—which is exactly what is happening in the United States as a result of the ACLU litigation.
As the debate over the patentability of genes continues to rage on, its effects will be felt in the form of high-profile government investigations (e.g., the SACGHS gene patent and licensing report and the Australian Senate’s similar investigation), more closely observed and contested patent proceedings and myriad other ways beyond the courtroom, in the United States, Australia and around the world.
Brazil signs deal with Pfizer to treat Gaucher's disease
http://news.xinhuanet.com/english2010/health/2010-09/29/c_13535374.htm
The 55 patients ALCL phase II trial was not pivotal, so I don't think it will be enough for approval.
SGEN/SGN-35 pivotal trial in HL - even better than phase I!
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted old entries; Added CIRSE, WSO, ACG, AAO, IDSA, ASTRO, SMR
SEPTEMBER 2010
International Society of Hypertension - ISH
Vancouver, Canada
September 26-30, 2010
http://www.ish-world.com/default.aspx?Home
OCTOBER 2010
American Society of Breast Disease, Breast Cancer Symposium - ASBD
San Francisco, CA
1-3 October, 2010
http://www.breastcasymposium.org/
Cardiovascular and Interventional Radiological Society of Europe - CIRSE
Valencia, Spain
October 2-6, 2010
http://www.cirse.org/index.php?pid=462
European Society for Medical Oncology Congress - ESMO
Milan, Italy
8-12 October, 2010
www.esmo.org/
World Stroke Congress - WSO
Seoul, Koera
October 13-16, 2010
http://www.world-stroke.org/meetings.asp
European Committee for Treatment and Research in Multiple Sclerosis - ECTRIMS
Gothenburg, Sweden
13-16 October, 2010
http://www.congrex.ch/index.php?id=77
American Society for Bone and Mineral Research - ASBMR
Toronto, Canada
15-19 October, 2010
http://www.asbmr.org/
American College of Gastroenterology - ACG
San Antonio, Texas
October 15-20, 2010
http://www.acg.gi.org/acgmeetings/
American Academy of Ophthalmology - AAO
Chicago, IL
October 16-19, 2010
http://www.aao.org/meetings/annual_meeting/
Infectious Disease Society - IDSA
Vancouver, Canada
October 21-24, 2010
http://www.idsociety.org/Content.aspx?id=238
American Association for the Study of Liver Diseases - AASLD
Boston, MA
October 29 - November 2, 2010
http://www.aasld.org/
American Society for Therapeutic Radiology and Oncoogy - ASTRO
San Diego, CA
October 31-November 4, 2010
http://www.astro.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
Society for Melanoma Research (International Melanoma Congress) - SMR
4-7 November
Sydney, Australia
http://www.melanoma2010.com/
----
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting any new items in chronological order.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added entry for AASLD”).
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pregnancy status is more relevant to the patient pool for MS...
On SGN-35 pivotal data in relapsed or refractory HL
What they probably need for approval in efficacy terms is ORR higher than 25-30% and durability longer than 5-6 months. I'm sure they will do better than that although not as good as in phase I (because trials design was very much alike but in the pivotal trial one of the Inclusion Criteria was: "Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant" while in the phase I trial not all patients got the transplant).
PS it's is already Mon. morning at my side of the globe
They have seemed to be one of the few (small) oncology companies that has had consistent successes and monocolonals seem to (still) be a promising technology
I'm guessing they want to move to front-line and other indications
FDA Labels of Approved MS Drugs - note that Copaxone is the only one in the list labeled Pregnancy Category B (Category C for all the rest).
An array of high-fat cheeses for me please, but you kids may skip it and proceed to the sweet desserts :)
I don't think the 0.5ml formulation (indeed it has the same active ingredient) has something that is patentable, it is quite obvious that a lower vol (less sterile water and mannitol) should cause less injection site pain. Teva clearly hopes to delay a generic to the 1ml product. Teva has another formulation - 40mg dose/three times a week for the same purpose.
Reminds me to renew my NOD32 licence and Nature subscriptions
Fear is stronger than common sense but hunger is even stronger. The potential gain is enormous, and so I hope those radicals can only slow but not block progress.
What's more interesting to me is what drugs will be combined with PLX to extend the impressive but still relatively modest duration.
Hummus strikes me as something that a competent home cook can make quite well
PLX4032 was designed to target a very specific mutation, the BRAF v600e mutation
I've posted on the flip side of RAF inhibitors in #msg-47959017. If you find this issue fascinating like I do, read this paper:
http://www.nature.com/nature/journal/v464/n7287/full/464358a.html
(I can email it to you if you wish)
[OT] I have scooped hummus with pitas all over the middle east for some decades now so I would like to comment:
First of, no such thing as 'the world's best hummus'. It's a matter of individual taste. However, in the first class level you can certainly find a few places in Tel-Aviv/Jaffa, usually run by Arab or Mizrahi Israelis. Comments/recommendations from hummus fans are mostly welcome.
The cost of sequencing individual genomes is dropping rapidly
Nice trick based on Israeli IP from Exotech BioSolution LTD . I wonder if it limits the absorption of other essential nutrients.
Be my guest
ARNA/lorcaserin - Fwiw, I consider a positive recommendation by the panel a miracle.
[OT] EyeamBill, one point regarding your iHub profile Favorite Quote - the origin is Groucho Marx and was used later by Woody Allen:
http://www.16-9.dk/2007-02/side11_inenglish.htm
In the oligosaccharide characterization territory I don't think Teva has experts like Ganesh Venkataraman and Ram Sasisekharan nor some "hidden magical" IP. I believe what Teva has done and can do is use all known techniques and tools to conducts the analysis. The one thing Roy, Jim and myself once thought could make a difference was when Teva has signed an agreement with Procognia under which Teva gained access to Procognia's proprietary glycoanalysis technology, but after digging there I've posted this isn't a possibility.