Gone for good.
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If Roche/Genentech were to be the partner these facilities would provide more than enough capacity.
Vacaville, California
Located on 100 acres in Solano County - just 50 miles northeast of San Francisco - the Vacaville site was acquired in 1994.
Today, the Vacaville site is one of the world's largest biotechnology manufacturing plants for the large-scale production of pharmaceutical proteins from mammalian cells. There are more than 427,000 square feet of space devoted to manufacturing, maintenance, laboratories, office space and warehousing.
http://www.gene.com/contact-us/visit-us/vacaville
Oceanside, California
Since 2005, Genentech has been expanding its facilities in Oceanside, about 35 miles north of San Diego.
Today, the campus spans 60 acres and includes a multi-product, biotech manufacturing and clinical operations complex with six buildings totaling 500,000 square feet. Upon receiving U.S. Food and Drug Administration licensure in 2007, the Oceanside facility added 90,000 liters of capacity that are now approved for the production of Rituxan and Avastin bulk drug substance.
http://www.gene.com/contact-us/visit-us/oceanside
Updated list of websites with open access.
Happy New Year
There are many more here:
http://www.biomedcentral.com/journals
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American Journal of Cancer Research
http://www.ajcr.us/
American Journal of Clinical and Experimental Immunology
http://www.ajcei.us/
BMC Biology
http://www.biomedcentral.com/bmcbiol
BMC Cancer
http://www.biomedcentral.com/bmccancer/
BMC Immunology
http://www.biomedcentral.com/bmcimmunol/
BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/
BMC Medicine
http://www.biomedcentral.com/bmcmed/
BMC Medical Imaging
http://www.biomedcentral.com/bmcmedimaging/
BMC Microbiology
http://www.biomedcentral.com/bmcmicrobiol/
BMC Molecular Biology
http://www.biomedcentral.com/bmcmolbiol/
Cancer Cell International
http://www.cancerci.com/
Cancer Immunity
http://cancerimmunity.org/
Cancer Medicine (brand new)
http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)2045-7634
Clinical and Developmental Immunology
http://www.hindawi.com/journals/cdi/contents/
Clinical and Translational Medicine
http://www.clintransmed.com/
EBMO Molecular Medicine
http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1757-4684
EJNMMI Research
http://www.ejnmmires.com/
Emerging Infectious Diseases
http://wwwnc.cdc.gov/eid/
Frontiers in Immunology
http://www.frontiersin.org/Immunology
Frontiers in Oncology
http://www.frontiersin.org/Oncology
Infectious Agents and Cancer
http://www.infectagentscancer.com/
International Journal of Biochemistry and Molecular Biology
http://www.ijbmb.org/contents.html
International Journal of Biomedical Imaging
http://www.hindawi.com/journals/ijbi/contents/
International Journal of Microbiology
http://www.hindawi.com/journals/ijmb/contents/
International Journal of Molecular Imaging
http://www.hindawi.com/journals/ijmi/contents/
The Journal of Biological Chemistry (Articles in Press only)
http://www.jbc.org/
Journal for Immunotherapy of Cancer (just started by SITC)
http://www.immunotherapyofcancer.org/
Journal of Oncology
http://www.hindawi.com/journals/jo/contents/
Journal of Translational Medicine
http://www.translational-medicine.com/
Leukemia Research and Treatment
http://www.hindawi.com/journals/lrt/contents/
Lung Cancer International
http://www.hindawi.com/journals/lci/contents/
Lymphoma
http://www.hindawi.com/journals/lymph/contents/
mBio
http://mbio.asm.org/
MicrobiologyOpen
http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)2045-8827
Neoplasia
http://www.neoplasia.org/index.php
OncoImmunology
http://www.landesbioscience.com/journals/oncoimmunology/
PLOS Biology
http://www.plosbiology.org/home.action
PLOS Genetics
http://www.plosgenetics.org/home.action
PLOS Medicine
http://www.plosmedicine.org/home.action
PLOS Neglected Tropical Diseases
http://www.plosntds.org/home.action
PLOS One
http://www.plosone.org/home.action
PLOS Pathogens
http://www.plospathogens.org/home.action
Radiation Oncology
http://www.ro-journal.com/
Translational Oncology
http://www.translationaloncology.org/
Vascular Cell
http://www.vascularcell.com/
Virology Journal
http://www.virologyj.com/
While this article in the WSJ isn't about Peregrine it does draw attention to
cancer immunotherapy. Not too long ago that would not have happened. The
anti CTLA-4 drugs are backed by major pharmaceutical companies, and that
makes all the difference.
The Future of Medicine Is Now
see the section: Letting Your Body Fight Cancer
http://online.wsj.com/article/SB10001424127887323530404578205692226506324.html?mod=WSJ_hppMIDDLENexttoWhatsNewsSecond
The top selling oncology drug today is also the first monoclonal antibody approved in the
United States, in 1997! Just think of all the other uses of bavi that will be found in the next 15 years.
http://en.wikipedia.org/wiki/Rituximab
I have to view this as a positive. Why grant options now unless they know something
good is about to happen and they want those shares at $1.18? Anything else doesn't
make a lot of sense to me.
I think the question is not the exercising of the options, but the granting of them
in the first place. Assuming that the Peregrine management knows the results of the
second-line NSCLC redo, does the granting of the stock options now violate insider
trading laws? I would guess not since they have plenty of attorneys to answer that
question. In that case it would be a strong bullish signal, would it not? Maybe
there is some sort of time interval involved as to when it is legal, or some
waiting period needed before the options can be exercised. Bungler, do you know?
We all know that. So what is your point? Every biotech company takes years and years
to get to a phase 3 trial, if they ever do.
This conference would seem to be the ideal place for Peregrine to present some imaging
data from the I-124/PGN650 trial. Nothing yet in the agenda, but I'll keep my eye on it.
Tumor Imaging in Cancer Drug Development
Boston, MA April 30 - May 2, 2013
http://tumor-imaging.com/
Is there something special about this happening during the first quarter of 2013?
The stock markets will be closed on Friday March 29 for Good Friday, so Thursday
March 28 is the last business day of the first quarter.
I will never get that opportunity since 45 was a while ago! Just to retire at some point is the goal now.
I don't believe this story because if you do a search of ClinicalTrials.gov for
"bavituximab AND temozolomide" there are zero trials listed. If they are using it in
patients it would have to be listed as a clinical trial, even if it is only for imaging.
Andy, it was mentioned in the PR from the quarterly report on Dec 10th.
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=725936
CJ posted about this article back in October.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=80557402
You can search here
https://iplanner.asco.org/gi2013/gi2013.aspx
I searched for Peregrine, bavituximab and phosphatidylserine and found nothing.
I am not surprised as Peregrine has never mentioned presenting anything at this conference.
This sould be of interest to many.
Oncology Times:
25 December 2012 - Volume 34 - Issue 24 - p 15–16
doi: 10.1097/01.COT.0000425688.25867.04
News
New FDA ‘Breakthrough’ Designation Aims to Speed Cancer Drug Approvals
Eastman, Peggy
WASHINGTON, DC—New breakthrough drug legislation enacted into law last July gives the Food and Drug Administration an important tool to move promising drugs from bench to bedside for cancer patients. That was the consensus of speakers at a clinical cancer research conference here hosted by Friends of Cancer Research (FOCR) and the Engelberg Center for Health Care Reform at Brookings.
At the meeting, which was supported by the American Society of Clinical Oncology, the American Association for Cancer Research, and Susan G. Komen for the Cure, S. Percy Ivy, MD, Associate Chief in the National Cancer Institute's Investigational Drug Branch, said the designation will be important for “exceptional new drugs that have the potential to change the way a disease is treated.”
Added panelist Wendy Selig, MS, President and CEO of the Melanoma Research Alliance, “I think having this kind of designation can really help patients. Late-stage cancer patients don't have time to wait for a lengthy process.” Asked by OT for comment, AACR CEO Margaret Foti, PhD, said, “We're hopeful. On the one hand, we need to do something. But at the same time we don't want to do harm.”
Keynote speaker Sen. Michael Bennet (D-CO), one of the sponsors of the new law, hailed its passage as a major accomplishment, especially since it was passed “at the height of one of the most dysfunctional Congresses in our history,” and six months before passage few people thought it would make it into law. Bennet said the legislation gives FDA “far more tools when a drug has promise early on.”
The FDA—which is currently writing a guidance document on criteria for the designation—already had three approaches to expedited drug development: accelerated approval; fast-track designation; and priority review. But the new law—which was included in the 2012 re-authorization of the Prescription Drug User Fee Act (PDUFA)—offers some potentially time-saving advantages, said panelist Robert Temple, MD, Deputy Center Director for Clinical Science in the FDA's Center for Drug Evaluation and Research.
“I think it does represent an important change,” he said. And while the concept of faster drug approval is not new, the legislative mandate for the breakthrough drug designation “makes us think collectively in a systematic way about this. We are going to be held accountable—that is a change. Fast-track didn't quite do that.”
Temple noted that as drug development becomes more genetically oriented based on molecular biology, there may be more and more cases where individual cancer patients have dramatic responses early on. So, drug sponsors will likely be increasingly asking, “When can early data make a convincing case that the drug is wonderful?”
Difference between Breakthrough & Fast-Track Designations
Asked by OT for more clarification on how the breakthrough designation differs from the fast-track designation, Temple said the fast-track approach has an intent to treat a broad range of serious diseases and the “potential to fill an unmet medical need,” which can be based on preclinical data, while the breakthrough category is intended to treat serious or life-threatening diseases and shows early clinical evidence of “substantial improvement over existing therapies.”
For example, a new breakthrough-designated drug under study might target a molecular driver of a specific cancer in humans, analogous to ALK for a subset of lung cancer patients.
Asked when FDA's guidance document on criteria for the new breakthrough designation might be finished, Richard Pazdur, MD, Director of FDA's Office of Hematology and Oncology New Products, Office of New Drugs, said the legislative due date is 2014, but “We intend to be faster than that.”
Regarding the review process, he emphasized that it will be stringently regulated, whether a drug in the breakthrough category is the subject of an Oncologic Drugs Advisory Committee public hearing or not. The ODAC meetings are “lots and lots of work,” and not every promising new drug can be scrutinized publicly in an ODAC meeting,” he said.“We have to be judicious in our use of taxpayer dollars.”
Sandra Horning, MD, Senior Vice President and Global Head of Clinical Development for Hematology/Oncology Product Development at Genentech, said that one of the major benefits of the breakthrough drug designation is that it calls for earlier and more frequent communication between a drug sponsor and the FDA during the drug development process. “Real-time communication” between the drug sponsor and FDA could certainly be a boon to expedited development,” she said. “Expedited development is really equal to interactive communication.”
As part of this process, data for an Investigational New Drug Application (IND) or Biologics License Application (BLA) are submitted as they are accumulated (rather than in one large final package), thus shortening the review time for the drug.
One important issue for industry, several speakers noted, is how manufacturers can gear up to produce enough of a breakthrough-designated drug if and when it is approved by FDA. “You have to scale up the [manufacturing] process chemically; it can be very difficult,” said Janet Woodcook, MD, Director of FDA's Center for Drug Development and Research. She noted that in the past there were poignant situations where groups had lotteries to determine which patients received a new drug developed under expedited review, and no one wants to see that happen again.
NCI's ‘Exceptional Cases’ Initiative
Speakers also discussed other ways of moving promising cancer drugs to patients faster. NCI Director and keynote speaker Harold Varmus, MD, described NCI's new “exceptional cases” initiative, which is designed to go from phenotype to genotype in investigating unusual anecdotes of marked patient response and rare responders in otherwise unsuccessful cancer clinical trials.
This initiative will screen cancerous tumors to find “actionable mutations” that might lead to improved treatment, he said. “Much of what we do these days fits under the rubric of precision medicine,” and as such, development of new cancer therapies is leading to novel questions for investigators to study, such as why some cancers can be treated successfully and others seem to have “undruggable” molecules.
What is known from The Cancer Genome Atlas (TCGA) at NCI, he noted, is that mutations in cancer tend to aggregate in pathways and networks.
Improving Accelerated Approval
Also discussed at the meeting was how to improve FDA's accelerated approval process, which grants conditional approval using a surrogate endpoint (such as tumor shrinkage) from a Phase II or interim Phase III trial (subject to confirmatory trials with hard clinical endpoints).
“In oncology I think most of us would agree that accelerated approval has been quite successful,” said Richard L. Schilsky, MD, Chief of Hematology/Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center. But he noted that accelerated approval has come under increasing scrutiny, with some charging that FDA is too lax when it comes to post-marketing studies and others stating that FDA is too strict with its approval criteria.
“We've been looking at situations where accelerated approval can be used for earlier stage disease,” said Schilsky, soon to be ASCO's Chief Medical Officer. “One problem is that there is a real lack of surrogate endpoints for accelerated approval. We propose to broaden the definition of ‘unmet medical need.’ Unmet medical need occurs in any non-curative setting.”
Disease-Specific Master Trial Protocol
Finally, panelists discussed improving the clinical trial process to speed new drugs to cancer patients via the design of a disease-specific master trial protocol.
Speakers described a prototype for non-small cell lung cancer: a Phase III master protocol multi-drug registration trial run by a neutral third party. In this trial, the biomarker for each compound tested must have been previously validated analytically. This master trial protocol would build on existing innovative clinical trial designs such as BATTLE (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination) and I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) for breast cancer.
© 2012 Lippincott Williams & Wilkins, Inc.
This is a really good piece about the potential of cancer immunotherapy told in the context of Steinman's own fight with pancreatic cancer.
A long NY Times Magazine piece about Ralph Steinman, who died of pancreatic cancer.
http://www.nytimes.com/2012/12/23/magazine/is-the-cure-for-cancer-inside-you.html?pagewanted=1&src=dayp
See you all on the other side of New Years.
NY Times article online. Maybe someday Dr. Thorpe will be there.
http://www.nytimes.com/2012/12/23/health/new-drugs-aim-to-make-cells-destroy-cancer.html?pagewanted=1&_r=0&hp
In case you missed it Thorpe did publish on p53.
Targeting mutant p53 protein and the tumor vasculature: an effective combination therapy for advanced breast tumors.
Breast Cancer Research and Treatment, January 2011, Volume 125, Issue 2, pp 407-420.
http://www.ncbi.nlm.nih.gov/pubmed/20349129
Here is my estimate for the enrollment of the first-line NSCLC trial.
My latest guesstimate is that in the control arm 75% of the patients had died by July 2012. I assume that the
control arm MOS = 12 months. I also assume that the treatment arm has yet to reach the point where
75% have died, now 5 months after the control arm did so. I expect Peregrine to wait until that happens
before reporting the "final" MOS. I am still hoping for mid-February.
In the table of phase III first-line NSCLC trials you can see that the Sandler et al trial (Avastin) and the
Scagliotti et al trial (motesanib) both increased the MOS by 2 months in the treatment arms.
In the Avastin case this increase was statistically significant (P = 0.003) and in the motesanib case
it was not (P = 0.14). Looking at the Kaplan-Meier curves gives an indication as to why this was so.
Sandler et al.
Scagliotti et al.
Motesanib is a "selective oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3;
platelet-derived growth factor receptor; and Kit", which makes it similar to sorafenib.
I have updated my table of Phase III first-line NSCLC trials. There are now 15 included.
All of them have control arms using carboplatin + paclitaxel, same as in the Bavi first-line trial.
I have highlighted in blue the maximums for each column. The Avastin trial still holds the record for largest
percentage increase in MOS (19.4%). If the Bavi first-line trial comes in with a control arm MOS of 13 months
and a treatment arm MOS of 17 months it would be an increase of 31%, still very good in comparison.
Is this a sign of things to come with Bavi and SBRT?
A Systemic Complete Response of Metastatic Melanoma to Local Radiation and Immunotherapy
Translational Oncology, Vol 5, issue 6, 2012
FREE: http://www.transonc.com/abstract.php?msid=351
Abstract
Background: Melanoma is a relatively immunogenic tumor, in which infiltration of melanoma cells by T lymphocytes is associated with a better clinical prognosis. We hypothesized that radiation-induced cell death may provide additional stimulation of an anti-tumor immune response in the setting of anti-CTLA4 treatment. Methods: In a pilot melanoma patient, we prospectively tested this hypothesis. We treated the patient with two cycles of ipilimumab, followed by stereotactic ablative radiotherapy to two of seven hepatic metastases, and two additional cycles of ipilimumab. Results: Subsequent PET-CT scan indicated that all metastases, including un-irradiated liver lesions and an un-irradiated axillary lesion had completely resolved, consistent with a Complete Response by RECIST. Conclusion: The use of radiotherapy in combination with targeted immunotherapy as a non-invasive in vivo tumor vaccine strategy appears to be a promising method of enhancing the induction of systemic immune responses and anti-tumor effect.
RRdog, I do agree that the MOS for the control arms should be somewhere around the
historical values and so the longer wait must be due to the treatment arms.
However, there is no guarantee that is so, it is always possible to have a control arm
that is an outlier. I remain optimistic but don't want to be too surprised by what could
happen, but hopefully won't.
Happy New Year to everyone,
FTM
I couldn't agree more.
Yes, I am hoping so, but again the control arms could be long too, we just don't know.
The expectations game. I am worried that we have gotten way ahead of ourselves for expectations
of MOS in the pancreatic and first-line NSCLC trials. We don't know anything about how both
arms have done in these trials and the comparison of the treatment arm MOS with the
control arm MOS is all that really matters. For both cases the historic data shows
little improvement in MOS when an experimental drug has been added to the standard chemo
used in the control arms. In first-line NSCLC adding Avastin to carboplatin + paclitaxel
increased MOS by only 20%. In pancreatic it has yet to be shown that adding another drug
to gemcitabine increases the MOS. There have been a few targeted drugs that work better
for small percentages of NSCLC patients with specific, and identifiable mutations,
but not for the general patient population. For pancreatic cancer the FOLFIRINOX regimen
works better than gemcitabine, but can only be used by the healthiest of patients
who can tolerate the side effects. This leads me to conclude that a 50% increase in MOS
would be an excellent outcome for bavi in both of these trials. The other thing to
remember is that both of these trials are relatively small. The first-line NSCLC trial
enrolled 86 patients, and the pancreatic trial enrolled 70 patients, and half of
the patients are in the control arms. That means that neither trial is likely to
have a MOS result that is statistically significant. If both trials have a 25-50%
increase in MOS I would consider them a great success and a validation of bavi,
and would support moving to phase III trials.
My point here is that I am trying to be more realistic so that even very good results
are not discounted because the expectations have become so large.
Liquid nitrogen maybe. I doubt helium.
I agree that having a proposed MOA is a very good thing. However, there are many drugs that have
been approved that don't have a good MOA described. Even now, 15 years after approval, papers
still appear about the MOA for rituximab (Rituxan), similarly for trastuzumab (Herceptin), and others.
The MOA for bavituximab has evolved from its original state to become more widely applied to treating
immunosuppression in the tumor microenvironment. I am sure there are more things to learn about
the MOA and how the anti-PS approach can be used to treat cancer. As we learn more new ideas about
treatment combinations with bavi will emerge.
I don't understand why Ebola is important since Ebola only kills a few hundred people a year at most,
and they are all poor villagers in central Africa. Other viruses are far more important to everyone. Take Dengue,
which actually has shown up in Florida and Hawaii, and will likely turn up in more places. I posted a recent article
about how Dengue uses PS to gain entry.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=81374675
Info on Dengue
http://en.wikipedia.org/wiki/Dengue
It infects 50 to 100 million people worldwide a year, leading to half a million hospitalizations, and approximately 12,500–25,000 deaths.
Obviously you can't test it in humans. There is a special approval path for things like this that can only use animal models.
Read the poster to find out.
There was a poster on Ebola presented at the 2010 Chemical and Biological Defense Science and Technology Conference
http://www.peregrineinc.com/images/stories/pdfs/cbdst2010.pdf
press release
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=531252
More on anti-viral at
http://www.peregrineinc.com/technology/bavituximab-antiviral/ps-targeting-data.html
Andy, yes I think so for future trials. Maybe they are building up their capacities and/or are looking
for more experienced people than they have.
I found this definition of CMC:
Chemistry, Manufacturing, and Controls (CMC) constitutes that part of pharmaceutical development
that deals with the nature of the drug substance and drug product, the manner in which both are made, and the
manner by which the manufacturing process is shown to be in control.
This job sounds like a position created to deal with problems like those in the second-line trial.
As it states in the abstract for the phase II trial the 30 months vs 13 was only for the SUBGROUP with stage IIIB
loco-regional disease. There were 35 patients in the SUBGROUP receiving BLP25 + BSC and 30 patients
in the SUBGROUP receiving only BSC. The whole trial had 88 patients receiving BLP25 + BSC and 83 patients
in the BSC only arm, total is 171. This is a very different patient population than in any of the bavi trials.
http://link.springer.com/article/10.1007%2Fs00432-011-1003-3
Again note that the phase III trial excluded patients with stage IV disease.
For those of you interested in the clinical trial of Threshold Pharmaceuticals drug TH-302 in previously untreated
pancreatic cancer, here is the presentation made at the ESMO 2012 Congress at the end of September.
http://www.thresholdpharm.com/pdf/borad_et_al_th-302_in_pancreas_cancer_esmo_9-12_with_supplement.pdf
Slide 20 shows the overall survival. Neither treatment arm was statistically different than the gemcitabine arm.
I did notice that ONTY closed at $4.50 yesterday and closed today at $2.19. Thanks for your support.
As an aside, I first invested in Biomira 6 or 7 years ago, but sold out. At the time it was a small Canadian
biotech in Edmonton. At the end of 2007 Biomira changed its name to Oncothyreon, did a 1 for 6 reverse
split, and moved to Seattle.