This morning, in one of my favourite blogs, 'Confused of Calcutta', I noticed a recent post I had missed:
"Today, at a time when Facebook announced passing 200 million members, there are still people who think that social networking sites and tools are a fad, an irritation, a waste of time. It doesn’t matter what you tell them: you can mention the role of such sites and tools in the Obama campaign, in the Mumbai terrorist attack, in challenging repressive regimes, in humdrum daily work. They don’t care, all this is just a waste of time. Just like e-mail was, and mobile phones, and BlackBerries. Just like computers were before that. Or for that matter the telephone."
Some of this might also be applied to the white elephant in the room that is Pharma, or perhaps some might think an ostrich in the sand might be more apt, yet an email from a friend brought me this interesting link on ADHD, showing a new information site on Facebook:
It was created by J&J's company, McNeil Pediatrics. Although ADHD is common in children, apparently 9M adults also suffer from the condition. The site is interesting because Facebook's new structure allows them to customise the tabs for different sets of information and education, including managing time and work overload/concentration issues. There are podcasts, links to experts, self assessment questionnaires and all sorts of other tools for sufferers to try out.
There is also a nifty Facebook feature that allows people to become a 'fan' of such site pages and thus virally spread the word, since others will see the notifications that X became a fan of Y in their Facebook lifestream. It will be interesting to see how the concept develops over time. It's not exactly direct engagement per se, but it's certainly a step in the right direction.
Two interesting and useful ideas caught my attention this morning involving the use of web2.0 tools or social media this morning involved doctors or patients in creative ways.
The first one was CMLEarth, an interactive website based on Google Earth for CML patients to tell their stories and share information with fellow sufferers of the disease. The site is for patients, caregivers and physicians around the world. There is a short demo about the idea on the front page and the site is sponsored by Novartis, the manufacturers of imatinib (Gleevec), the first tyrosine kinase therapy approved for the treatment of chronic myeloid leukemia (CML) in 2001.
Another cool idea that I liked was a story about a community hospital in Pennsylvania, founded in 1923 and owned and operated by Doylestown village. There, they are using iPhones to improve efficiency and productivity as well as utilise some nifty tools:
"Using iPhone and MEDITECH, doctors can see everything needed for patient care, including vital signs, medications, lab results, allergies, nurses’ notes, therapy results, and even information about patient diet."
Clearly, these ideas are just examples, but over the next few years we may well see plenty of other innovative approaches and technologies being used in the medical profession as smart phones become more sophisticated and new applications are developed. In the past, doctors have loved the Palm PDA's, so it is interesting to note an increase in the use of Apple's iPhone technology in improving patient care. If you have come across any other ideas, do feel free to share them too.
Physicians and medical institutions should shun gifts, reps, samples and ghostwriting, said the Institute of Medicine's conflict of interest committee in its full recommendations.
After recently writing about Dendreon's Provenge and other prostate cancer drugs, the long awaited survival data has finally been revealed in a late breaking abstract at the American Urological Association.
Unfortunately, when I tried to access the abstract online, the sign-up form said it would take several days for someone to get back to me. Huh? Obviously they have a ways to go in communicating data compared to their efficient brethen at ASH and ASCO, who allow guests, patients and interested parties to sign in and freely read the abstracts from the meetings.
The snapshot of the data is therefore summarised here courtesy of Forbes, Dendreon's press release and the WSJ app on my iPhone (the website will frustratingly only give you the first paragraph or so).
Essentially, Provenge prolonged the lives of men with advanced prostate cancer who had failed hormone therapy and were not responding to treatment with hormonal therapy. Taxotere was previously approved after failure of hormone therapy with improved survival by 3 months over placebo and a response rate of approx. 18%. Provenge extended life by 4.1 months in previously pre-treated patients (25.8 vs. 21.7 months), a statistically significant result (P<0.032).
However, the trial design makes it difficult to compare whether Provenge exerted any effect over Taxotere alone. Therapy was started with either
with placebo or Provenge. As soon as tumours grew, men on placebo
got a frozen version of Provenge, followed by Taxotere. Those who started on Provenge also got Taxotere
when they stopped responding to initial treatment. There was no Taxotere only arm to determine the incremental effect of Provenge, as might be expected. Therein lies the rub for ODAC and the FDA.
In 2007, the FDA declined to approve the vaccine, preferring to wait for survival confirmation from the 512 patient IMPACT study presented today. Those discussions led to a target of a reduction in risk of death by 22%. The IMPACT data just squeaked in at 22.5%. There is no guarentee that approval for Provenge will be a dead cert given the marginal improvement, unconventional trial design and likely exhorbitant price.
The main advantage of Dendreon's Provenge over chemotherapy is better tolerability, since the most common side effect was flu-like symptoms but not heightened stroke or cerebrovascular events, whereas Taxotere can cause severe myelosuppression, fatigue and occasionally, febrile neutropenia.
The next six months will be interesting as a) Dendreon can expect to file with the FDA later this year and b) ODAC can give biotech companies with fuzzy trial designs a run for their money; remember GPC/Spectrum and satraplatin? I'd sure love to be a fly on the wall for the Dendreon ODAC meeting...
Disclosure: To avoid confusion, I should add that while I don't normally tend to post immediate news about drugs or pharma on this blog, my particular interest stems from having lost a dear father to the disease 9 years ago. It is my hope that one day others will have a better opportunity for an improved quality of life after being diagnosed with advanced cancer. Most advances are inevitably incremental, rather than being a lengthy improvement in quality of life and survival, as Gleevec was for CML patients. As for Dendreon's Provenge, I'm not sure that flu-like symptoms and a high price tag will be the panacea that many patients and their families were hoping for :(
Essentially, GSK's lapatinib
(Tykerb) yielded tumor responses in 39% of women with HER2+ inflammatory breast
cancer heavily pretreated with chemotherapy, including trastuzumab
(Herceptin). The phase II trial has been reported in The Lancet.
These patients typically have a poorer prognosis, so one wouldn't
expect much of a response, but almost 40% in a difficult to treat group
of patients is quite dramatic. What was even more interesting was the
lapatinib responses lasted an average of 20.9 weeks with a
progression-free survival of 14.9 weeks, a very good clinical response
indeed, suggesting use of the therapy earlier, ie upfront, may lead to
hopefully longer responses; time will tell, but the initial results are promising so far.
Kaufman, B., Trudeau, M., Awada, A., Blackwell, K., Bachelot, T., Salazar, V., DeSilvio, M., Westlund, R., Zaks, T., & Spector, N. (2009). Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a phase II study The Lancet Oncology DOI: 10.1016/S1470-2045(09)70087-7
Onyx Pharmaceuticals Inc. and partner Bayer ended a late-stage study of its drug Nexavar in skin cancer patient because the drug was not working to improve patients' overall survival rate. The companies said an independent data monitoring committee concluded the drug would not meet its treatment goal of improved overall survival in patients.
"On 23rd April 2009 the Committee for Medicinal Products for Human Use (CHMP), adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Iressa, 250mg, film coated tablets intended for the treatment of non-small cell lung cancer (NSCLC). The Applicant for this medicinal product is AstraZeneca AB."
Furthermore, the announcement went on to say:
"The approved indication is: Iressa is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK."
Irrespective of the ongoing questions being discussed in both NSCLC and CRC, it is clear that companies are going to need ways of helping oncologists best to select patients for their treatment, either clinically or with a biomarker.
This blog post is inspired by the enigmatic Eric Garland, who gave a superb presentation at the recent annual SCIP meeting in Chicago. Sadly, I missed the event due to business commitments, but he kindly shared the deck as you can see below:
I'd like to take a couple of general points he raised and relate them to the Pharma and Biotech. First of all, Eric stated:
"For competitive intelligence to survive it must blend with psychological reality and focus on business development, not just Cold War 'enemy tracking'."
This is so true. CI is not an academic exercise and most marketing folks are usually intuitively on top of what what's going on in their market. There is nothing worse than spending five or six figures of precious budget only to be told what you already knew. Monitoring studies are on their way out. But that's the big white elephant in the room that many CI people are slow to catch on; companies can no longer afford to spend over $1M in salary and benefits to indulge a group mere academic confirmatory studies. Thus, we find they may well be a dying breed.
The smart companies are thinking differently.
They're integrating CI, landscape assessments, KOL research and highly technical analyses in one project via the market research or marketing departments that helps them understand the bigger strategic issues to enable smarter decision making. We've started seeing more of these complex RFP's coming through lately and they make my heart sing. Why? Because they excite us - it's a chance to work in partnership with the cross functional team and really make a difference - either through identifying suitable licensing candidates that may make a real difference to patients lives or through creatively finding new ways to increase brand revenues. That's where you add significant value to an organisation.
The other idea I liked from Eric's presentation was this chart about how the future of intelligence might look:
The top ideas for the next 1-5 years are already happening now in technical fields such as oncology, hematology, immunology and HIV, as are technological revolutions. As more and more smarter targeted agents are hitting the cancer market, the role of biomarkers, histology and gene mutations are increasingly affecting how patients might be segmented and treated. Technolical advances in cancer research at the molecular level is quite frankly astonishing, although there is still a huge body of research yet to be done.
Gone are the days when new drugs came out and everyone got blindly treated with them, irrespective of whether they could predict whether they would actually work or not. Now you have to understand the science and biology of the disease as well, which is no bad thing. The Obama Stimulus Plan will help in this regard,
With higher priced drugs hitting the market, you'd better have a sensible rationale for WHY, WHERE and WHO your drug might actually be suitable for. The massive block of older baby boomers will soon to be eligible for Medicare coverage, the cost of therapies in the OECD and developing world are rapidly increasing. Major decisions need to be made on rational treatment and reimbursement or the global health care system will be as broke as the banking system. Another bubble could soon be in the making, only this time it's Pharma getting greedy, with inevitable predictable consequences.
Going back to competitive intelligence, how does this all hang together? Well, the smarter companies are using CI to inform business decisions, integrating it with marketing and business develepment/licensing, analysing markets to address health and lifestyle issues and driving the future portfolios for real growth. The slow companies are still out in left field, focused inwardly on 'competitors' and what they're doing. It's no longer good enough to be 24th to market with yet another me-too similar drug.
Innovation, integration and thinking differently will be the keys to success as the baby boomers become seniors in the next few years. That takes boldness and creativity to think outside of the box; it is also a very long and lonely road, but thank goodness there are some enlightened companies out there treading that path rather than be stuck in left field doing the same old, same old.
There are many lessons for microbicide access can be drawn from the international family planning/sexual and reproductive health movement and its successes and difficulties in reducing fertility rates throughout the world. This report covers the execution issues.
With 6,800 new HIV infections occurring globally each day, new prevention strategies are desperately needed. While microbicides are not a magic bullet, researchers believe they could prevent millions of infections. And with leading scientists concluding that a vaccine is likely to be at least 10 years away, we need to make a strong commitment to developing microbicides. Scientists estimate that even a 60 percent effective microbicide could prevent 2.5 million HIV infections in three years among women, men and children in the developing world.
A UN population fund report has shown, in India, a majority of married women are subject to forced sex, and are hence vulnerable to HIV.// Therefore, there is a definite need for protective methods that are under the control of a woman, as the prevalent male-controlled methods are not even 20 percent helpful. A new thrust to the fight against HIV/AIDS may be provided by over-the-counter microbicides, which are gels, creams, films, or suppositories, meant for women. This is a blessing for many sex workers, who despite stocking up with condoms are unable to persuade many a recalcitrant customer to use protection. This callousness is present despite the awareness about AIDS in India, which has touched the five million mark.
Microbicides would provide an additional, complementary tool for individuals and communities to protect themselves against HIV infections and other STIs. For women, it would represent the first female-controlled method of protection against HIV and STIs. With the option of contraceptive and non-contraceptive microbicides, women could choose to become pregnant without risking HIV or other STI infections. For people living with HIV/AIDS, microbicides could help prevent infections from STIs, prevent re-infection with strains of HIV and provide protection in sero-discordant couples.
Topical microbicides are pharmaceutical products, which function through a variety of mechanisms disrupting the entry or the life cycle of the HIV virus. Some microbicides have also properties that make them effective against other sexually transmitted infections or make them effective contraceptives. There are no microbicides on the market today, but clinical trials in humans have begun with 18 preparations and several others are under preclinical research. It seems realistic to assume that within 5-10 years a few of the preparations would have finalized phase 3 studies and if successful, accepted by regulatory authorities.
New, anti-infective substances that can be developed as gels, creams, foams, films, even impregnated sponges and suppositories may prove to be a ground-breaking approach to preventing the spread of HIV, the virus that causes AIDS, according to an international authority and clinical pharmacologist at Advocate Bethany Hospital in Chicago, Illinois. The substances, called microbicides, are currently being developed for use in women prior to sex as a way of preventing the spread of such sexually transmitted diseases as gonorrhea and syphilis.
The Initiative brought together experts in scientific research, product development, public health, economics and advocacy, to help bring to market this critical health technology that women worldwide are demanding as they cope with staggering levels of HIV/AIDS infection. The results are five fact-based studies that detail:
* A scientific plan for accelerating development;
* A pharmaco-economics study of the potential market size and the expected return on investment;
* An assessment of the public health impact;
* A framework to ensure access to the products;
* A plan of action for microbicide advocacy.
Research funding of £90m is to be directed towards British researchers to develop a gel which will “stop HIV/Aids in its tracks” reported The Times. It is hoped the funding by the UK government and the Bill and Melinda Gates Foundation will lead to a gel that could be applied before sex to prevent transmission of the HIV virus. A gel of this type is important as it would allow women to apply their own protection rather than relying on a partner to use a condom.
Microbicides kill or immobilise sexually transmitted infectious (STI) pathogens, form a barrier between the pathogen and the vaginal or rectal tissue, block the infection early on, prevent the pathogen from replicating once it has entered the cells, and boost the vaginal defence system. Norick says that microbicides protect both partners and that some can even prevent pregnancy. Most of them will eventually become available across the counter and inexpensively too.
To prevent sexually transmitted HIV, the most desirable active ingredients of microbicides are antiretrovirals (ARVs) that directly target viral entry and avert infection at mucosal surfaces. However, most promising ARV entry inhibitors are biologicals, which are costly to manufacture and deliver to resource-poor areas where effective microbicides are urgently needed. Here, we report a manufacturing breakthrough for griffithsin (GRFT), one of the most potent HIV entry inhibitors.
HIV is a serious and growing women’s health issue globally. In Sub-Saharan Africa, 61 percent of all adults living with HIV are women, and the number of women and girls infected with HIV has increased in every region of the world, with rates rising particularly rapidly in Eastern Europe, Asia, and Latin America. Biologically, women are two to four times more vulnerable than men to sexually transmitted HIV infection. Their vulnerability increases due to their lack of economic and social power in many societies, where women often cannot control sexual encounters or insist on protective measures such as abstinence or mutual monogamy. Many women who get infected with HIV have only one partner – their husbands.
The Pharmaco-Economics Working Group was established as part of the Rockefeller Foundation’s Microbicide Initiative, started in early 2001. This was
one of four Working Groups formed to examine the key steps in creating a microbicide: (1) understand the public and private views of investment in microbicide development; (2) develop ways to ensure access to the product; (3) advocate investment in and adoption of a product; and (4) identify the scientific and technical requirements for developing a product. The reports from the other Working Groups are contained in companion volumes
within this series. The pharmaco-economic work has been completed in two sections: the private investment view and the public investment view. This report covers the private investment view of the microbicide market.
“Community involvement” represents on-the-ground implementation of science’s accountability to society, at the local as well as global level. Engaging a wide range of stakeholders as active and informed partners in decision-making about the research and its implementation enhances both the scientific validity and ethical integrity of clinical trials. This has been widely recognised in the field of AIDS research, and almost all publicly-funded research networks require a community involvement component. Generally this has been done by forming a community advisory board (CAB) or similar structure, a model developed in the US in the early days of activist involvement in HIV treatment trials. Recently, however, research networks are questioning whether the CAB model is the best or only approach to developing partnership with communities. The community liaison teams at various trial sites are exploring a variety of strategies to engage with communities as partners in the research enterprise
Two competing bills introduced last month aim to cut a clear pathway for approval of generic biologic drugs and to save patients and insurers billions of dollars by offering cheaper generics. Gaining consensus on generic biologics will likely not enjoy the broad support of embryonic stem cell research. Fierce debate looms on how long the original maker of the biologic should be granted patent exclusivity. Prospective manufacturers of generic versions are backing one bill that sets the basic exclusivity period at five years, while the other -- supported by developers of original biologics -- calls for a minimum of 12. Unlike regular medications, generic versions of biologics -- often called follow-ons, biogenerics or biosimilars -- have no practical regulatory pathway for approval.
"While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP's presentation at ASCO," said Hal Barron, M.D., senior vice president, Development and chief medical officer, Genentech. "We remain fully committed to the ongoing Avastin adjuvant programs in early-stage colon, breast and lung cancers."
Genentech, Inc., announced today that the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-08 study did not meet its primary endpoint of improved disease-free survival (DFS) with adjuvant use of bevacizumab (Avastin®) plus chemotherapy in patients with early-stage colon cancer. This was based on results from the final analysis of the NSABP C-08 study, a randomized multinational phase III study designed to evaluate the efficacy of adjuvant 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX), with or without bevacizumab, in patients with resected stage II or III adenocarcinoma of the colon. Bevacizumab is already approved by the US Food and Drug Administration for the treatment of metastatic colorectal cancer. This is the first phase III study of bevacizumab in early-stage disease.
Smokers with high levels of two chemicals in their urine were more likely than others in a study to get lung cancer, a finding that may lead to a new test to predict risk in time to prevent or treat the disease. High levels of these chemical byproducts of tobacco smoke in the urine were linked to lung cancer rates as much as 8.5 times higher than those of other smokers. Data was reported this week at AACR in Denver.
The number of cancer research grants funded by the U.S. government may rise 25 percent to 30 percent in the next two years as federal cash infusions replenish the budget for medical research, the nation’s top cancer official said. More projects will be approved because the National Cancer Institute received a 2.9 percent budget increase to $5 billion for fiscal 2009, and $1.3 billion for 2009 and 2010 from the economic stimulus package. The new grants will help universities recruit faculty and fill research jobs frozen in recent years. The rise in research grants follows four years of a flat- lined budget for the cancer institute, which is one of 27 agencies within the National Institutes of Health in Bethesda, Maryland. Science is better off under the new Administration, that's for sure.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and serious virus infections, today reported that two preclinical studies presented during the AACR 100th Annual Meeting 2009 provided further confirmation of the immunomodulatory mechanisms contributing to the anti-tumor activity of its phosphatidylserine (PS) targeting antibodies. One study confirms the anti-tumor effects and immune stimulating ability of a fully human anti-PS antibody and the other demonstrates the ability of a second fully human anti-PS antibody to stimulate development of a critical component of the adaptive immune system.
The role of TP63 in cancer remains controversial since both oncogenic and tumor suppressive actions have been reported. p63 protein is found in the nuclei of basal cells of the normal prostate, yet it is absent in the vast majority of prostate cancer nuclei. Since a complex array of TP63 mRNA transcripts encode polypeptides with distinct functional properties, it is important to determine which forms are expressed in normal and prostate cancer tissue.
Genomic technologies offer the promise of a comprehensive understanding of cancer. These technologies are being used to characterize tumours at the molecular level, and several clinical successes have shown that such information can guide the design of drugs targeted to a relevant molecule. One of the main barriers to further progress is identifying the biological indicators, or biomarkers, of cancer that predict who will benefit from a particular targeted therapy.
Well, it will be interesting to follow the tweets of competitive intelligence professionals such as Arik Johnson, August Jackson, Suki Fuller, Ellen Naylor and others from the annual meeting. I'm looking forward to hearing what's hot and what's not in the CI world.
For those of us not able to attend the meeting, we can follow the news remotely as they relay their their tweets and commentaries either in the widget below or from Twitter Search. Thank goodness for modern technology that now allows us to tweet one meeting live and keep tabs on two others in different cities on the same continent. Amazing stuff!
For all the Pharma peeps like me who couldn't make it to Boston for Shwen Gwee's Unconference on Social Pharma (Social Media in Pharma) you can follow his tweets and those of anyone else at the meeting in the widget below or use Twitter search to follow the #SocPharm hashtag easily in your web app.
What a week! I'm still in Denver, CO for the American Association of Cancer Research meeting (#AACR), which you can follow in the blog post widget further down the page. It's an exciting meeting - mTOR, HDAC and biomarkers are the hot topics at this years annual meeting. More on those later when I get time to write some more detailed posts about the the data.
It's triple play week and the other big conference happening at the same time is the Society of Competitive Intelligence annual meeting in Chicago. You can follow that meeting using #scip or #scip09. I'll be posting a CoverItLive widget for easy tracking of that event in a moment.
Meanwhile, do join in remotely and ask @shwen questions about social media in pharma - just remember to use the #socpharm tag in your tweets to make it easy for people to follow all the conversations.
The TSP researchers uncovered a total of 57 genomic changes that occur frequently in lung cancer patients. Of these changes, more than 40 appear to be associated with genes not previously known to be involved in lung adenocarcinoma. More research is needed to precisely identify and characterize these genes, but researchers are excited by the possibility that their findings may suggest new ways of attacking this deadly cancer. The most common abnormality identified by the TSP team involves a region on chromosome 14 that encompasses two known genes, neither of which had been previously associated with cancer. Through additional studies in cancer cells, the researchers discovered that one of the genes, NKX2.1, influences cancer cell growth. NKX2.1 normally acts as a master regulator that controls the activity of other key genes in cells lining the lungs’ tiny air sacs, called alveoli.
Patients with coactivation of TTF-1 and NKX2–8 pathways appears to be resistant to standard cisplatin therapy, suggesting the need for alternative therapies in this cohort of high-risk patients. NKX2 is known as a marker of poor prognosis in lung cancer.
Craig Venter, a biotechnology pioneer, is usually a fan of brash upstarts. A decade ago he upstaged the boffins of the official Human Genome Project by privately sequencing his own genome faster and more cheaply. But he remains sceptical about analysing only the SNPs. He wants to see whole genomes sequenced because “we don’t yet know which parts of the genome are medically relevant.”
Rapalogs may be more effective in combination with other anticancer agents, including chemotherapy and targeted therapies. It is increasingly apparent that the mTOR signaling network is quite complex, and rapamycin treatment leads to different signaling responses in different cell types. A better understanding of mTOR signaling, the mechanism of action of rapamycin, and the identification of biomarkers of response will lead to more optimal targeting of this pathway for cancer therapy.
The investigators found that MCL had the unfortunate characteristics of being incurable as with indolent lymphomas, yet often rapidly progressive, similar to aggressive histologies. Median overall survival (OS) cited in these early series was in the range of 2 to 4 years, prompting several groups to propose novel therapeutic approaches to improve patient outcomes.
Vorinostat monotherapy is well tolerated in patients with recurrent GBM and has modest single-agent activity. Histone acetylation analysis and RNA expression profiling indicate that vorinostat in this dose and schedule affects target pathways in GBM. Additional testing of vorinostat in combination regimens is warranted, most likely with temozolomide.
Picoplatin demonstrated clinical efficacy in platinum-refractory SCLC. The major toxicity was hematologic. These results warrant further evaluation in this patient population.
The PI3K/Akt/mTOR pathway is activated in the majority of pancreatic cancers, and inhibition of this pathway has antitumor effects in preclinical studies. We performed a multi-institutional, single-arm, phase II study of RAD001(everolimus), an oral inhibitor of mTOR, in patients who experienced treatment failure on first-line therapy with gemcitabine. Not effective as a single agent - needs to be used in combination with CT
The phosphatidylinositol 3-kinase (PI3K)/Akt and mTORC1 pathways are frequently activated, representing potential therapeutic targets in acute myeloid leukemia (AML).
The mTOR kinase is the catalytic subunit of two functionally distinct complexes, mTORC1 and mTORC2, that coordinately promote cell growth, proliferation, and survival. Rapamycin is a potent allosteric mTORC1 inhibitor with clinical applications as an immunosuppressant and anti-cancer agent. Here, we find that Torin1, a highly potent and selective ATP-competitive mTOR inhibitor that directly inhibits both complexes, impairs cell growth and proliferation to a far greater degree than rapamycin.
Effective medical therapy for persistent/recurrent medullary thyroid carcinoma (MTC) is not available, yet. Everolimus (RAD001) is a Rapamycin derivative, a potent mTOR pathway inhibitor. RAD001 has been employed in several clinical studies demonstrating antiproliferative and apoptotic effects in human tumors, both in vitro and in vivo, also in combination with somatostatin analogs. Results suggest Afinitor might be a useful treatment in combination with octreotide
After RCC, what next for Afinitor? Preclinical data suggest that mTOR may be a good target for breast cancer therapy, especially in tumors with Akt activation resulting from either growth factor dependency or loss of PTEN function.
The mammalian target of rapamycin (mTOR) is a serine threonine kinase implicated in cellular response to nutrients and growth factor signaling. mTOR functions downstream of phosphatidylinositol 3’-kinase (PI3K) and AKT and is abnormally activated in a number of different tumor types. mTOR inhibitors are consequently increasingly recognized as an important new therapeutic class of agents in the treatment of cancer. Two mTOR inhibitors or rapalogs - temsirolimus and everolimus - have undergone phase III trials in renal cell carcinoma (RCC), and temsirolimus has entered clinical oncology practice after it was approved by the US Food and Drug Administration for use in RCC. mTOR inhibitors are also under clinical investigation in a broad variety of other solid tumors. Both temsirolimus and everolimus are now approved in advanced RCC.
This blog is published by: Sally Church, PhD of Icarus Consultants, Inc. The contents of this blog are the intellectual property of the author and all rights are reserved. No commercial use, copying or distribution is permitted without the author's express permission.
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Icarus Consultants is a management consulting company focusing on marketing strategy and new product development to the Pharma and Biotech industry. We focus on specialist areas such as oncology, hematology, immunology, respiratory and HIV.
Our particular areas of interest include social media monitoring, key opinion leader research, competitive intelligence and landscape opportunity assessments. We use primary qualitative market research and buzz metrics to support our strategic analyses.
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