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Saw that earlier
On July 20, 2011, the Company entered into a Purchase Agreement (the “Private Placement Purchase Agreement” and, together with the Registered Direct Purchase Agreement, the “Agreements”) under which the Company agreed to enter into a private placement with other accredited institutional investors, Dr. Max E. Link, who is the Chairman of the Company’s Board of Directors, and an accredited institutional investor affiliated with Dr. Augustine Chow, another...
‘No Politician Left Behind’
July 13, 2011
New Law, ‘No Politician Left Behind,’ Would Pay Congressmen Based on Performance
Controversial Law Draws Howls of Protest from Lawmakers
WASHINGTON (The Borowitz Report) – A government think-tank today proposed a controversial new law, “No Politician Left Behind,” which would pay congressmen solely on the basis of performance.
The law, which was proposed by the University of Minnesota’s Institute of Government, “would make a serious dent in the Federal deficit because few if any congressmen would ever have to be paid,” said the Institute’s director, Davis Logsdon.
“Right now, congressmen get paid even when they storm out of budget negotiations in a hissy fit,” Mr. Logsdon said. “Under this new law, the rule would be, no budget, no paycheck.”
The idea of being paid per accomplishment drew howls of protest from lawmakers, many claiming that if the law were enacted it would result in their financial ruin.
“If passed, this law would be tantamount to the establishment of ‘Work Panels,’ which would determine whether individual congressmen are accomplishing anything,” said Rep. Eric Cantor (R-VA). “I, for one, would be in deep, deep trouble.”
“I’m fairly sure that this law is unconstitutional,” said Sen. Mitch McConnell (R-KY). “Now, I have never actually read the Constitution, but if this law were passed I would probably be forced to read it or live in a cardboard box.”
House Speaker John Boehner (R-OH) said that creating performance standards for lawmakers was “an insult to the institution of Congress.”
“We have spent millions of dollars, some of it out of our own pockets, to get to Washington,” he said. “We did not come here to be treated like teachers.”
For Saturday entertainment
Shark Decides To Jump The Surfer
http://www.thepostgame.com/features/201106/tired-jump-shark-how-about-shark-jumps-surfer
Hurricane Season is here, leveraged oil ETF's
short - SCO
long - UCO
A link that is days ahead of NOAA
http://www.crownweather.com/?p=6517
A long road to victory. How are the early patients holding up?
Formerly known as Isologen
See the photo of the woman 7 years after first treatment, also very impressive results on scars. As doctors work with this therapy they will no doubt use it off label.
Poniard Pharmaceuticals
A turkey indeed.
krammer, I hear the e-minis are acting strange overnight
Thought you might be up late to shed a little light on what some are saying looks significant and possibly ominous for the opening?
Thanks for any insight.
Goldman downgraded the Semis
Semi Equipment sector downgraded to Cautious from Neutral at Goldman
Goldman downgraded the Semi Equipment sector based on expectations that strong 2010 and 2011 capex will lead to excess wafer start capacity in 2012. As part of the sector rating change, the firm downgraded KLA-Tencor (KLAC) to Sell from Neutral and Applied Materials (AMAT) to Neutral from Buy, and upgraded Lam Research (LRCX) to Buy from Neutral. Additionally, the analyst downgraded Intel (INTC) to Sell from Neutral.
http://www.theflyonthewall.com/permalinks/entry.php/INTC;KLAC;AMAT;LRCXid1432133/INTC;KLAC;AMAT;LRCX-Semi-Equipment-sector-downgraded-to-Cautious-from-Neutral-at-Goldman
The market, in general, feels like no-man's land. Lately, TWM has worked well for overbought spikes.
siga-246
It is difficult to precisely define the potential contributions of each agent to the patient's recovery because of the close timing of administration. Vaccinia virus DNA levels in blood samples decreased from pretreatment levels following VIGIV and cidofovir treatment, then continued to decrease with the administration of ST-246, especially with achievement of target peak and trough ST-246 plasma concentration levels (figures 2B and 3). It appears that the patient mounted his own anti-orthopoxvirus IgG response between days 9 and 10; maximum IgG levels were achieved between hospital days 12 and 18 (figure 2A). Additionally complicating interpretation of the impact of individual interventions, we cannot yet differentiate between the patient's own IgG and that contributed by the VIGIV treatment. Although it is difficult to assess and differentiate the effects of specific therapeutic interventions, the child's immune response almost certainly played a role in the eventual control of his infection [16].
http://cid.oxfordjournals.org/content/46/10/1555.full
reminder that -246 is going to be purchased under BARDA.
Biased, but a link well worth reading
Curis and the Swiss Army Knife
12/7/2010
Rick Currin
On the failures:
* One has to wonder why Genentech chose two of the harshest trials for the drug."
* From our review of the research, several much more promising areas for hedgehog inhibition are small cell lung cancer, prostate cancer, pancreatic cancer, and breast cancer.
* So while hedgehog signaling may not have been effective in colorectal cancer or ovarian cancer harboring kras mutations it is feasible and perhaps even likely that adding a drug that helps block kras (a PI3K or HDAC inhibitor for example) will be effective in a combination. From our point of view Curis stands in a unique position to tackle combination therapies and attract licensees on its way to long term success
http://www.currinbiotech.com/articles/20101209
More on Pancreatic
2011 Jan 5
Rationale for Inhibition of the Hedgehog Pathway Paracrine Loop in Pancreatic Adenocarcinoma
hedgehog pathway contributes to the molecular conversation between tumor and its microenvironment through a (paracrine loop)
Olive et al. [32] provided evidence that chemotherapy does not have access to the tumor cells in KRAS and p53 mutant pancreatic adenocarcinoma xenografts in a gemcitabine resistant mouse model due to poor vascularization of the tumors. When combining gemcitabine with hedgehog inhibition (IPI-926, a specific SMO inhibitor) however, tumor vasculature and subsequently gemcitabine delivery in the tumors were enhanced. Mean vessel density and CD31 positive cells increased whereas stromal myofibroblasts were reduced. Mice treated with the combination had their tumors reduced in size, undergoing apoptosis and had significantly improved survival eventually. On the other hand, IPI-926 had no effect on cell proliferation in these KRAS driven tumors.
...implying the possible role of hedgehog inhibition in reducing the stem cell burden of the tumor that is responsible for resistance to therapy and recurrences
...Both studies concluded that the addition of hedgehog inhibition in chemotherapy specifically targets aldehyde dehydrogenase positive cells and reduces the number of metastases observed whereas it does not have significant effect on primary tumor volume.
http://www.joplink.net/prev/201101/01.html
Logic in Pancreatic Cancer
Some recent studies now make that case. They argue for the idea that the stroma is blocking drug penetration and contributing to tumor survival, and that drugs that punch holes in the stromal barrier can be effective. “It's hard to get drug into a rock,” said Robert Wolff, M.D., an oncologist at the University of Texas M. D. Anderson Cancer Center in Houston. “If you can soften up the rock, you may be able to get a better therapeutic index.”
http://jnci.oxfordjournals.org/content/early/2010/03/25/jnci.djq113.extract
Acquired resistance to tyrosine kinase inhibitors, similar
Frederic de Sauvage and colleagues examine the mechanism of resistance.
The authors examined the mutation status of hedgehog pathway components in a tumour sample obtained following the patient's relapse and discovered a G to C mutation in SMO that changed the aspartic acid at position 473 to histidine (D473H). This mutation was not present in normal skin
... in response to SMO-D473H, indicating that the mutation leads to GDC-0449 resistance without compromising hedgehog pathway activation by SMO. Binding assays with 14C-labelled GDC-0449 showed that the drug could not specifically bind SMO-D473H.
Although initial clinical trial data with GDC-0449 have been positive, it seems that tumours are likely to acquire resistance to inhibitors of G protein-coupled receptors such as SMO, like they do to tyrosine kinase inhibitors, emphasizing the need to identify ways in which resistance can be circumvented.
http://www.medscape.com/viewarticle/715704
GDC-0449 is very effective until some BCC and meduloblastoma patients develop resistance? Not likely the resistance can be reversed.
=================================
Published Online 2 September 2009
Looks like old news. A better link for those interested
http://www.sciencemag.org/content/326/5952/572.figures-only
Interfering with resistance in medulloblastoma
2010 Sep 29
addition of the PI3K inhibitor NVP-BKM120 or the dual PI3K-mTOR (mammalian target of rapamycin) inhibitor NVP-BEZ235 to the initial treatment with the Smo antagonist markedly delayed the development of resistance. Our findings may be useful in informing treatment strategies for medulloblastoma.
http://www.ncbi.nlm.nih.gov/pubmed/20881279
Resistance in Medulloblastoma
The infamous 26YO
The authors found that a specific mutation in Smoothened (SMO) present in the tumor after relapse had no effect on Hedgehog signaling but did disrupt the ability of GDC-0449 to bind to SMO. Since SMO is the direct molecular target of GDC-0449, its inability to effectively bind to SMO in this patient likely led to the emergence of drug resistance. This work provides the first evidence that a family of receptors, of which SMO is included, may be subject to the development of drug resistance by mutation of a region of this receptor.
http://www.drugs.com/clinical_trials/curis-announces-gdc-0449-phase-clinical-data-published-new-england-journal-medicine-7989.html
" a family of receptors, of which SMO is included " "by mutation of a region of this receptor"
=============
Epub 2010 Dec 1
Small molecule inhibition of GDC-0449 refractory smoothened mutants and downstream mechanisms of drug resistance.
* individual ultimately relapsed with a D473H resistance mutation in Smoothened (SMO)
* we substituted D473 with every amino acid and found that all functional mutants were resistant to GDC-0449
* resistance may also occur downstream of SMO
http://www.ncbi.nlm.nih.gov/pubmed/21123452
Pipeline?
From the 10-K
CUDC-101
* In April 2010, we completed a dose escalation phase I clinical trial of this molecule.
25 patients
with advanced, refractory solid tumors
* In August 2010, we initiated a phase Ib expansion trial
50 patients with specific tumor types, including head and neck, non-small cell lung, breast, gastric and liver cancers
38 patients in this trial as of March 3, 2011
((Unusually fast enrollments for US based trials by a small company. Doctors favoring this trial?))
* We also anticipate initiating a phase I clinical trial of CUDC-101 in advanced head and neck cancer patients...during the first half of 2011.
We selected head and neck cancer as our first indication for potential Phase II testing of CUDC-101 for several reasons. First, CUDC-101 demonstrated biological activity on two patients with head and neck cancer in Phase I dose escalation study, including a mixed response in a head and neck cancer patient at 150 mg/m2 dose level and a tumor reduction of over 20% after just four weeks of study drug administration in another head and neck cancer patient at the 275 mg/m2 dosing level. Second, our research team generated strong in vitro and in vivo preclinical data in head and neck cancer, exemplified by data in seven head and neck cancer cell lines that includes some of the highest potency observed of the cell lines in which CUDC-101 was tested. Lastly, we believe that this internal data is supported by published literature demonstrating that both EGFR and Her2 are often implicated in head and neck cancers.
===================
"exemplified by data in seven head and neck cancer cell lines that includes some of the highest potency observed of the cell lines"
(((Looks like biomarkers have been found, a primary focus for the FDA)))
Positive skin cancer drug data boosts Roche
Analysts at Deutsche Bank estimate the total market is unlikely to exceed $500 million and see peak sales of 300 million Swiss francs ($331.7 million).
http://www.reuters.com/article/2011/03/21/roche-idUSLDE72K19F20110321?feedType=RSS&feedName=rbssHealthcareNews&rpc=43
Anxious to see if the actual data reveals biomarkers and hope for expanded indications.
Found more interesting links at this link:
http://caps.fool.com/Pitch/CRIS/4344844/gdc-0449-is-in-a-pivotal-phase.aspx
Japan down 1300 points
Looks like the public has lost trust:
Here, Tokyo Electric Power Co., which is working to avert a meltdown in Fukushima, is the poster child of distrust. In 2002, whistleblowers revealed abuses that forced it to say it had faked reports on repairs since the 1980s. Its chairman and president resigned and all 17 of its reactors were temporarily shut by government inspectors.
Amidst the latest accident, in Fukushima, Tokyo Electric is facing criticism for responding slowly. What a shock! This latest fiasco further damages the industry’s reputation after a string of embarrassments over the last 12 years.
http://www.bloomberg.com/news/2011-03-15/debt-tsunami-fights-radiation-for-bigger-risk-commentary-by-william-pesek.html
BARDA-CBRN-BAA-11-100-SOL-00009
Announcement Type and Date: Initial Announcement, March 4, 2009. Renewal Announcement March 4, 2011
page 8
Area of Interest #2: Antitoxins and Therapeutics
2.3 Development of monoclonal anthrax antitoxins including non-clinical, completion of a phase 1 trial; development of a phase 2 clinical development, manufacture at pilot scale under GMP; process development and scale up including fill-finish.
2.4 Development of novel formulations of monoclonal anthrax antitoxins.
https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=89ba389b4424e98020cb3de547001825&_cview=0
First 3-D Images of the Sun
If you're even a little nerdy you will want to take a quick look at this
http://www.nasa.gov/mission_pages/stereo/news/stereo3D_press.html
Re: end of month paint & labor report rally
...always feels good to laugh
SHARP trial was halted early for approval
The placebo-controlled trial conducted in Spain 603 patients
median overall survival of 10.7 months for sorafenib and 7.9 months for placebo
median time to progression of 24 weeks for sorafenib and 12 weeks for placebo
http://www.medscape.com/viewarticle/576128
Why all the recent fund raising?
Feels like a pivotal quarter. Best scenario, Celsion wants a solid financial position to allow them to wait for data to mature and get better terms in a partnership.
Looking at the bar for approval based on Nexavar SHARP results.
The approval of sorafenib in 2007 for the treatment of HCC patients in both the United States and the European Union represents a true paradigm shift in the treatment of advanced HCC and is a clinically meaningful therapeutic advancement in this challenging malignancy. Interestingly, a subsequent prospective controlled trial of sorafenib in Asian patients with the same design and eligibility criteria as the SHARP trial showed an improvement in OS with a hazard ratio similar to that of the SHARP trial. However, the Asian study showed significantly lower absolute benefit (6.2 months median survival in the study arm v 10.7 months in SHARP) and possibly overall lower toler- ance of sorafenib.105 Understanding the reasons for such differential effects is essential to inform the design of future trials in HCC and underscores the importance of identifying stratification factors in future clinical trials, such as hepatic function, ethnicity, disease etiol- ogy, and tumor molecular profile.
http://files.shareholder.com/downloads/CLN/0x0x393141/dba27485-464e-4cec-a208-ca3f5d2f85de/JCO_2010_-_08-03-2010_ThermoDox_Chart_3.pdf
The second trial
226 Asian patients
median overall survival of 6.2 months for sorafenib and 4.1 months for placebo. There was also a significant 74% improvement in time to progression, with a median time to progression of 2.8 months for sorafenib and 1.4 months for placebo
Anyone have a link to an ASCO board
It's the big annual Cancer Conference and the small biotechs with good or even big news love to release trial data. My favorite time of the year to pick up stocks is now. The Medical World on Wall Street starts cranking out some predictions about mid Feb.
Thanks,
If anyone has any links?
Zab, about the Dry Bulkers
I recently read an article about a big supply of new ships is flowing into the market and depressing shipping rates. If I can find it I will link it for you. Maybe time to short an overpriced one? Any ideas.
I'm ahead of you on the markets. I'm into paranoia trading, flip 'em so often it's impossible to profit.
A Sunday without football? ughh. Hope that little city of Green Bay can show the world money can't buy everything.
I hope everone remembers BARDA never awarded a contract for 2011
I'm also expecting some sharp cuts in defense. How much will DOD be willing to spend on a smallpox contract? Just some things to consider if you get a large pop. Booking some gains may not be a bad idea.
Siga is looking like a solid short. Perelman and his behind the scene legal small print has backfired in so many ways. Remember the SBA refusal of the initial BARADA contract?
No idea where momo trading gang will take this Monday. If investors had a massive short position there no doubt PIP would be on it's way to 'da moon.
Stimuvax, is it attacking brain metastsis?
However, once activated, both T cells and B cells can search the brain for an antigen like the one that activated them. If they don't find it, they leave the brain and return to the blood.
http://www.omsusa.org/pranzatelli-immune.htm
plateau has been reached...median survival time of 17 months
Patients with unresectable locally advanced stage III disease (IIIA and IIIB without malignant pleural effusion) also comprise an important target population in clinical research. Although there is a better chance of a positive outcome in such patients given that overt disease is limited to the thoracic cavity, it has become clear in recent years that a plateau has been reached in terms of what is achievable with chemotherapy and radiotherapy in this setting. Survival figures currently observed in selected patients with stage III NSCLC treated with concurrent chemoradiotherapy are in the order of a median survival time of 17 months and a 3-year survival rate of 25% [30]. Although these clearly represent an improvement in outlook from only a few years ago, novel strategies which improve survival while not increasing toxicity to unacceptable levels are urgently needed. To this end, attention has turned to whether the incorporation of consolidation or maintenance therapy into treatment regimens for stage III disease might improve clinical outcome. Although current data are somewhat limited, several randomized studies have been carried out in this setting.
http://theoncologist.alphamedpress.org/cgi/content/full/15/10/1034#F2
The January AAR report is particularly interesting
Warren Buffett’s - choice of railcar loadings as one of the economic indicators he would wish to receive if stranded on a desert island. The January AAT report is full of extra info likely to quoted all year:
http://www.aar.org/NewsAndEvents/~/media/aar/railtimeindicators/2011-01_rti.ashx
Therapeutic cancer vaccines – there’s a new kid on the block
MUC-1
Near the front of the queue is Merck Serono’s Stimuvax, in a phase III registration trial for stage III unresectable non-small-cell lung cancer. The vaccine showed a small survival benefit at phase II, when it was trialled in 171 patients with later stage disease – stage IIIb/IV. But when the results for the locoregional stage IIIb patients were looked at in isolation, patients with the vaccine showed an additional 17 months survival over the control arm. “If you are treating patients with NSCLC this is really outstanding,” comments Oliver Kisker, head of Merck’s Global Clinical Development Oncology unit. The phase III eligibility criteria were therefore adjusted to include only patients with stage III unresectable disease. If the phase III results bear out the promising phase II data, and if the trial remains on track, Kisker believes Stimuvax could be the next vaccine to make it to market. “Certainly it has the potential to be the first active anti-cancer vaccine – true anti-cancer vaccine,” he says.
Stimuvax primes the immune system to lock on to MUC-1 (or mucin-1), which was one of the antigens used as a target in the very early experiments with immunotherapy done in the 1970s by Cancer Research UK, among others. Because MUC-1 is present in a high proportion of tumours not only in NSCLC, but also breast, prostate, colorectal, ovarian and other cancers, the hope is that if and when the treatment gets approval for lung cancer, it will be possible to take the vaccine forward across a number of other cancers as well.
Merck Serono obtained the exclusive worldwide rights for development and commercialisation of Stimuvax from the former Canadian and now American biotech Oncothyreon, who did the early development under the name L-BLP25. Growing confidence in the therapeutic potential of MUC-1 targeted vaccines is also seen, for instance, in the decision by Novartis to sign a $10?million deal with the French biotech Transgene, for exclusive development and commercialisation rights on a similar vaccine, TG4010, also in trials for use in NSCLC.
Unlike some cancer antigens, MUC-1 is also expressed by normal secreting cells – in the intestines, for instance – giving rise to the theoretical possibility that an anti-MUC-1 vaccine could trigger an autoimmune response and turn the body’s immune system against itself. However, ten years of experience using the vaccine in more than 1000 patients seems to indicate that the vaccine is selective for tumour MUC-1 expression, says Kisker. “It has not shown any side-effects that point to unwanted activity against the physiological expression of MUC-1.”
The Stimuvax NSCLC trial was put on temporary hold in March this year, when a myeloma patient developed encephalitis after receiving the vaccine. “We worked very closely with the FDA, and with the treating physician and neurology specialists. But overall it remains completely unclear what happened here, so we cannot rule out that Stimuvax might have had a role. We have not seen anything like this elsewhere, so we just don’t know,” said Kisker. So far there have been no reports of any MUC-1 expression in the tissue of neural or central nervous system organs.
Merck got the go ahead to resume their NSCLC trial in June with some additional safeguards in place, and Kisker remains confident that cancer vaccines are on track to join established cancer therapies. “These types of immunotherapies have the potential to become effective and low toxic treatments in the future. In the past it has been shown that development is not that easy, and we must be prepared for setbacks also in ongoing research, because we don’t understand fully all the details of the factors that are required to generate an effective immunotherapy. I think, in principle, all these therapies, like MAGE-A3 and other cancer vaccines currently in phase II and III, have the potential to become effective treatments in the future. We need to await the results from the clinical trials.”
“These type of immunotherapies have the potential to become effective and low toxic treatments in the future”
Therapeutic cancer vaccines – there’s a new kid on the block
...conintued from last link
After millions of years of evolution the immune system has more than a few sophisticated tricks up its sleeve
Then there is the question of cost. While $93,000 for three to four months extra survival may not look like a bargain, Provenge is in some ways highly unrepresentative of the field, as it is engineered for each patient individually using whole cells taken from their tumour. By contrast, most of the therapeutic cancer vaccines that are likely to enter the market in coming years will be ‘off the shelf’, with many targeted at antigens such as MUC-1 and MAGE-A3 that are present across a wide spectrum of cancers. The potential for pushing down costs in these cases is clear.
... The next approvals are widely expected to be in non-small-cell lung cancer and lymphoma. Melanoma vaccines have continued to disappoint, although there are now hopes that they may be more effective in combination with low-dose chemotherapy, says Dalgleish.
...The wrong stage
As with cancer drugs, the early vaccine trials tended to be in very late-stage disease, but experience has shown that vaccines struggle to have any impact in this setting. With vaccines, it will always be the earlier the better, says Dalgleish
http://cancerworld.org/Articles/Isseus_39/Cutting_Edge/Therapeutic_cancer_vaccines_%96_there%92s_a_new_kid_on_the_block.html
Article type: Cutting Edge
Axel Ullrich is openly tipping immunotherapy as the most likely field for the next major breakthrough in cancer – “Only the immune system is so clever that it can track down a cancer cell wherever it is in the body”
A COMPELLING CONCEPT
Therapeutic cancer vaccines are all about equipping the patient’s own immune system to fight their cancer. It is a compelling concept on many fronts. On the risk-benefit front, vaccines are not associated with the sort of side-effects that make a patient’s life miserable and put their long-term health and quality of life at risk – a big plus.
On the scientific front, after millions of years of evolution the immune system has more than a few sophisticated tricks up its sleeve...
Impatient investors
Unlike most cytotoxic and cytostatic drugs, therapies that involve reprogramming a body’s immune system and sending it into action need a bit of time to take effect. Dalgleish believes his prostate cancer vaccine Onyvax could have beaten Provenge to the market had the investors held on for survival figures rather than pulling the plug at nine months, when no real difference had emerged between the vaccine and control arms. “Dendreon [manufacturers of Provenge], who had the same good results as we did in a small group, also had nothing at nine months when they did the randomised study. But they had deep pockets, and they kept going. And between 9 and 12 months the survival curve starts splitting in favour of the vaccine.” This is a pattern, he adds, that has also emerged from a number of recent lung cancer trials: “I think you can almost superimpose the survival graphs.” So this is another lesson. “Especially in the randomised studies, you don’t get the earlier split you get in the phase II studies.”
patient population
This study is a randomized (2 getting vaccine for every 1 getting placebo), double-blind (both sides will get injections on the same schedule, so it won’t be clear who’s receiving active treatment), placebo-controlled trial of 1300 patients with stage IIIB unresectable locoregional (”dry”, without a malignant pleural effusion) who have demonstrated a response or stable disease after at least two cycles of platinum-based chemo with radiation.
http://onctalk.com/?p=247
"locoregional (”dry”, without a malignant pleural effusion)", patient profile more likely to have chemotherapy cures. Hard to find a median survival with BSC for this subpopulation, anyone?
stage IIIA versus IIIB
Most commonly, patients are classified as stage III because of involvement of lymph nodes in the mediastinum (a space in the middle of the chest between the two lungs). If the involved mediastinal lymph nodes are on the same side of the chest as the lung tumor (ipsilateral nodes), this is classified as N2 and is considered stage IIIA disease. If the involved lymph nodes are on the opposite side of the mediastinum (contralateral nodes), these are considered N3 nodes, and the cancer is stage IIIB. If a patient has involvement of supraclavicular lymph nodes (just above the collar bone, or clavicle) on either side, these are considered N3 lymph nodes, and the stage is likewise IIIB.
frist line:
The most commonly used regimens are cisplatin and etoposide at full dose, or carboplatin and Taxol given weekly at low doses with radiation
median survival of about 22 months
It is important to note that this trial included patients with squamous cell cancers, a group who we now know does NOT appear to benefit from Alimta. Currently, a randomized phase III study comparing cisplatin/Alimta/radiation to the old standard cisplatin/etoposide/radiation is underway - only patients with non-squamous cancers are being included.
http://cancergrace.org/lung/2010/08/22/introduction-to-locally-advanced-unresectable-stage-iii-nsclc/
Trying to determine expected control arm median survival
Stimuvax phase II trial
171 patients IIIB LR or stage IIIB with malignant pleural effusion, and stage IV
results were not statistically significant
subgroup stable or responding disease after any first-line
Stimuvax arm compared with BSC alone (49% (n=17) vs. 27% (n=8))
median survival 30.6 months vs. 13.3 months, respectively
http://www.advfn.com/news_Stimuvax-Phase-II-data-highlight-three-year-survival-results-for-patients-with-n_22137963.html
Valortim trial at stage 2 exposure
African Green Monkey Model (human trials will not be done post stage 2 exposure)
6 AGMs were treated with one intravenous dose of 10 mg/kg Valortim® when positive by ECL; a second cohort of 6 AGMs was treated with 2 intravenous doses of 10 mg/kg Valortim® (the first given when positive by ECL and the second dose administered 24 hours later), and a third cohort of 6 AGMs was treated with one intravenous dose of 20 mg/kg Valortim® when positive by ECL.
Results showed that 56% (10 of 18) of the Valortim®-treated animals survived while all saline-treated controls (3) succumbed to inhalational anthrax on or before the fifth day post-exposure. Extended time-to-death (days 6-9) was observed in 5 of the 8 Valortim®-treated animals that succumbed to inhalational anthrax.
http://phx.corporate-ir.net/phoenix.zhtml?c=191999&p=irol-newsArticle&ID=1200718&highlight=
ONE DOSE Valortim, versus 60 days of IV antibiotic treatment now approved that results in 90% death for stage 2 patients.
Now you see why the DOD will continue funding Valortim trials.
Current Antibiotic Treatement
Inhalation anthrax is usually treated with intravenous (IV) ciprofloxacin plus another antibiotic.
The length of treatment is currently about 60 days for individuals exposed to anthrax, since it may take spores that long to germinate.
http://www.nlm.nih.gov/medlineplus/ency/article/000641.htm
60 days IV therapy, if not caught early you get 90% failure
Current treatment for Inhalation Anthrax
Treatment
Several antibiotics are effective against anthrax, including penicillin, doxycycline, and ciprofloxacin. Inhalation anthrax is usually treated with intravenous (IV) ciprofloxacin plus another antibiotic.
The length of treatment is currently about 60 days for individuals exposed to anthrax, since it may take spores that long to germinate.
Outlook (Prognosis)
The prognosis of inhalation anthrax once it reaches the second stage is poor, even with antibiotic therapy. Up to 90% of cases in the second stage are fatal.
(second stage)
The bacteria spores must "germinate," or sprout ( the same way a seed might before a plant grows) before the actual disease occurs. The process usually takes 3 to 14 days, with 43 days being the longest known incubation period.
Once the spores germinate, they release several toxic substances, which cause internal bleeding, swelling, and tissue death.
PIP loaded with shorts
11-30 numbers shows 2 million shares short. Schwab shows this stock as a "hard to borrow". That doesn't add up? Wall Street manipulation playing short term swings just got surprised by the good news. If Pharmathene becomes too difficult (cost risk) to manipulate the big trend will start and I suspect it's a long ride to the upside over 2011.
GLTA, waiting to see if EOD provides lower entries. In my paranoid world I don't think Wall Street wants this one closing strong today.
(Siga is also "hard to borrow")
Valortim following same path as siga-246
The DOD orders come after human safety studies are completed, more safety studies coming. Much, much faster path to sells compared to normal FDA approval and marketing approval process.
Final siga-246 safety study followed by an order 5 months later:
SIGA Completes Fourth Successful Human Safety Clinical Trial
Date : 06/23/2010 @ 8:30AM
http://finance.yahoo.com/q/h?s=PIP&t=201...
Patience should be rewarded. The big boyz must collect shares before they allow the share price to actually start the trend higher.
Great story and price regardless of how the Siga trial turns out. (I'm guessing good news coming soon on Siga front)