Mary Beth Cicero: Why I’m Walking in the Great Strides Walk for Cystic Fibrosis May 20
May is Cystic Fibrosis Awareness Month and one of the largest national fundraising events takes place this Sunday. It is the Great Strides Walk, which is taking place in over 200 cities this Saturday and Sunday, May 19-20. (Click to find out more about Great Strides, including walk locations.)
I will actually be walking twice! Last year when Drug Market Info was looking for CF patients to interview for our Cystic Fibrosis Market Info report, I contacted my good friend Sue (whom I hadn’t seen in years) but knew her daughter had CF. We ended up interviewing her and a number of her friends from western Massachusetts and were completely touched by their stories.
Our interviews with these patients and caregivers took place last November and they mentioned the Great Strides Walk to me. I promised them that I would be there and so here it is May and I am on my way to both Northampton and Shelburne Falls Mass. I will be supporting Team Paige and Audrey’s Angels.
I am so excited because I will be meeting some of the patients and mothers we interviewed that contributed so many insights to our Cystic Fibrosis Market Info report. I truly hope that the patients’ perspectives they shared will influence companies to either undertake further drug development on Cystic Fibrosis or take their needs into account. (You can get the facts on Cystic Fibrosis here.)
I am particularly excited to meet in person one of the patients we talked with that has had 2 lung transplants—she touched my heart and I can’t wait to meet her! When I asked her about her goals in life she said she didn’t have any. Her mother interjected that she doesn’t know how long she will live and doesn’t like to think about the future. Of course, I jumped in and said, “Why don’t you want to be the first person to have 3 lung transplants!” I am hoping that won’t have to happen and that she will thrive and be happy.
She did mention that she always wanted to go skydiving. Even though I want to make her happy… I am drawing the line at skydiving! However, I am going to take her zip lining and I am happy to report that Bob Coughlin (President of Mass BIO, read our Notes & Notable interview with Bob Coughlin) who has a son with CF is not as “chicken” as me and has graciously agreed to take her sky diving.
To all of you out there with CF and to those who love you, as well as all of the drug researchers trying to cure this disease—I salute you and will be proudly walking alongside of you on Sunday.
Prostate Cancer Notes and Notable – Dr. Tomasz Beer, co-author of Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials
Drug Market Info presents Prostate Cancer Notes and Notables, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)
Today’s interview is again with Dr. Tomasz Beer, M.C., F.A.C.P.. (Click here for yesterdays interview focusing on Prostate Cancer) Dr. Beer is a medical oncologist who leads a research and clinical trial program at Oregon Health & Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer devoted a good portion of the past year to writing a book about cancer clinical trials together with Larry Axmaker, Ed.D, a cancer survivor and clinical trial participant. The book is entitled Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials. Dr. Beer co-authored this book because he wanted to contribute to the fight against cancer. Here are his comments…
Please tell us a little about your new book and who should read it?
“Cancer Clinical Trials” is written for people living with cancer, their families and loved ones. We hope to make clinical trials and the experimental therapies they offer much less intimidating and by doing so, help people make the best decisions for their cancer care. We delve into all facets of clinical trials, from design and principles, to strategies for finding and choosing a trial to issues of insurance coverage and many other practical aspects.
We have found the book is also of interest to physicians in training, nurses, and other health professionals who interact with patients and need to know the fundamentals of experimental cancer therapy. It may also be of interest to pharmaceutical companies who want to understand how to approach clinical trial recruitment.
What prompted you to write this book?
For 15 years now, I have been deeply involved in clinical trials. I have talked to thousands of cancer patients about hundreds of clinical trials. Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients. The book was the only way to get this done.
What do you think is the most important message (or most unique point) in the book?
The book is meant to be an A to Z guide to clinical trials, from what they are, to how to decide if a clinical trial is right for one’s cancer care plan, to many practical aspects of
taking part in a clinical trial. There are many different messages I would want to highlight. If there is one, I would say that in cancer care, there is a need for improvement and advances throughout the continuum of cancer care.
Clinical trials are not just for folks who have no other options. Even when a well-established standard treatment is available, there is often room for improvement. Every person diagnosed with cancer should be knowledgeable about clinical trials so they can make truly informed decisions about their care.
What makes patients willing (or not) to participate in a clinical trial? Does the type of trial make a difference?
I think a trial needs to make sense for a particular situation. First and foremost, it has to be a well-designed trial that asks a sensible question. It has to offer a sensible alternative to the other options. There has to be some potential advantage, for example more effective therapy or less toxic therapy. What that translates into varies greatly by situation.
In prostate cancer, for example, there are situations where the disease is growing slowly and we would ordinarily just watch it. Very low risk interventions may be attractive here. There are also situations where the disease is very aggressive and other treatments aren’t working. More risk might be appropriate in that setting.
What do patients need to be aware of before they decide to enter a trial?
The single most important thing is to be knowledgeable about one’s disease and standard treatment options. Only then can one put a clinical trial option in perspective. We have a whole list of tips on our blog. I encourage readers to take a look at: http://www.cancer-clinical-trials.com/2012/04/practical-tips-on-choosing-clinical.html.
Would the book be beneficial for a company conducting clinical trials?
Absolutely. Participation in clinical trials remains disappointingly low. For companies working hard to move a drug forward, this results in far greater cost. From the time it takes to get a trial done, to the number of sites needed to complete a study, the low participation of people living with cancer is a major challenge to the pharmaceutical industry. We expect that the book will provide cancer patients the knowledge they need to confidently consider a clinical trial for their cancer care and therefore increase trial participation. We think every oncology office that conducts clinical trials should have this book available to their patients as a critical educational resource.
The book may also help with subject retention. Early drop out of research subjects is another challenge for clinical trials. When this happens for good reasons, such as dangerous side effects, that is unavoidable. We believe sometimes it also happens because patients don’t have enough knowledge about how to navigate the responsibilities of being a study participant. The book can help.
Is there anything that would help companies conducting clinical trials?
We think that making the book available at trial sites so that patients can approach their care decisions with strong knowledge about clinical trials will increase trial accrual. Folks already participating in a trial will also feel more secure in being a study subject armed with the knowledge the book provides. Our clinical trial system is incredibly inefficient and dismal participation of cancer patients in clinical trials is a key contributor. We are convinced that accessible knowledge about clinical trials will help substantially.
Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials by Tomasz M Beer, MD and Larry Axmaker, Ed.D
Pub. Date: April 2012/Price: $16.95
ISBN 13: 978-0-9823219-7-3/Trade Paperback: 192 pages
Where can Cancer Clinical Trials be purchased?
The easiest way is to go to Amazon.com and type in “cancer clinical trials” or “Tomasz Beer.” The book shows right up. You can also go to the book’s Amazon page. For bulk purchases, a discounted price may be available from our publisher. More information can be found on the authors’ blog and at the publisher’s website.
Prostate Cancer Notes and Notable – Dr. Tomasz Beer, Chair for Prostate Cancer Research Deputy Director, OHSU Knight Cancer Institute
Drug Market Info presents Prostate Cancer Notes and Notables, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)
Today’s interview is with Dr. Tomasz Beer, M.C., F.A.C.P., a medical oncologist who holds the Grover C. Bagby Endowed Chair for Prostate Cancer Research and leads a research and clinical trial program at Oregon Health and Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer has been in practice for 15 years and is the author of hundreds of medical publications. He recently co-authored a new book entitled Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials (which will be discussed in tomorrow’s blog post). Here are his comments on treating prostate cancer:
How long have you been working with prostate cancer?
I have worked with prostate cancer for 15 years and have been actively involved in more than 100 clinical trials for prostate cancer.
What is the most difficult issue(s) for patients with regard to prostate cancer treatment and how does this get addressed?
I don’t think there is a simple answer to this question. For many men, it’s the decision about initial treatment following diagnosis. The choice between surgery, radiation, and observation is very challenging. In advanced disease, it’s often about managing the side effects of treatment to preserve quality of life.
The treatment armamentarium for prostate cancer has recently expanded significantly. How is this changing the actual treatment approach?
There are many more treatment options for advanced disease. When prostate cancer becomes resistant to standard hormonal therapy, we now have a number of life-extending options. That is brand new and very good news.
With all the changes, where do you see a drug like Provenge fitting into the treatment scheme?
Provenge offers a survival advantage for men with metastatic, castration-resistant prostate cancer that are free of symptoms or nearly free of symptoms. The sequence of treatments is in such rapid evolution, that we need to keep paying attention to this question. Because immuno-suppressing drugs may interfere with a response to Provenge, the timing of Provenge treatment needs to consider not only the patient’s condition but also other treatment before and after Provenge. Ideally, patients should not receive steroids or other immuno-suppressive drugs for 3 months before and after Provenge.
In your experience, what percentage of men with prostate cancer agree to enter a clinical trial and does this differ by disease stage? How does this compare to other types of cancer?
I work in a university setting, so the folks I meet may be more inclined to consider trials. In choosing us, they may have expressed an openness to clinical trials, so I don’t know if my experience reflects that of all. Having said that, in our practice more than half of our patients are open to clinical trials and around 25 to 30% end up participating. The level of interest is very high and I think that is true at all stages of the disease.
How do you feel about the proposed changes to the PSA screening recommendations and what do patients generally want to do about annual screenings?
I think men need to understand both the potential benefits and risks of early detection. I don’t think we should be discouraging screening. I think we should be discouraging screening without a balanced and thorough discussion. New data from additional follow-up of the European study are showing more favorable results than initially reported and I would think that the USPSTF should consider these new data and think about these tough issues some more.
What should new drug developers keep in mind as they develop new therapies for prostate cancer?
With so much progress over the last few years, it would be easy to think that prostate cancer is saturated with new drugs. This is not so. Men are still dying of the disease and we need to continue to strive to make progress until that changes. The field is more complicated and new drugs need to be quite a bit better than current drugs to compete, but the need remains.
And last, tell us a bit about your new book?
Co-authored with Larry Axmaker, a cancer survivor and clinical trial participant, the book, Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials, is designed to demystify clinical trials for cancer patients and their families and loved ones. The book provides an easy to read and understandable, yet comprehensive guide to clinical trials and aims to help people develop a foundation of knowledge, make an informed and thoughtful decision about the role of clinical trials in their care, and navigate through the experience of being a participant. For more information, please visit the authors’ blog and to take a look at the book directly, please visit http://tinyurl.com/cancer-clinical-trials-book.
Cystic Fibrosis Notes and Notable – Dr. Brian O’Sullivan, Cystic Fibrosis Center Director, UMass Memorial Medical Center
Drug Market Info presents Cystic Fibrosis Notes and Notables, an interview series with leading voices in the fight to cure Cystic Fibrosis.
Today’s interview is with Dr. Brian O’Sullivan, Cystic Fibrosis Center Director and Professor of Pediatrics at the University of Massachusetts Medical School. Dr. O’Sullivan, who has been working with CF since 1987, was asked to comment on recent developments in the treatment of Cystic Fibrosis. Here are his comments:
What are the biggest hurdles to treating CF?
The single biggest hurdle is patient adherence to medication usage. We ask them to do so much and many of the therapies are very time consuming (nebulizers and chest physical therapy). It is hard for patients to do all that they should.
What are the top advances that you have seen in last five years for CF patients and what is on the horizon?
Kalydeco (recently launched) and the other Vertex compound (VX-809) in clinical development are the top advances. Hopefully other approaches to the basic CF defect will continue to be developed in the next five years for Cystic Fibrosis. I am also looking forward to PTC Therapeutics Ataluran (PTC-124) Phase 3 trial results. Gene therapy studies will be important going forward.
In your opinion, what are the major benefits and drawbacks of Vertex’s recently approved Kalydeco?
The major drawback for Kalydeco is the limited applicability. FDA approval is needed for all Type 3 mutations, not just G551D. The cost ($300,000 a year) is just too much for patients and insurers to swallow. Obviously, if more patients are eligible to use it the cost can come down.
Do most CF patients already know their specific CF mutation and when is this genetic testing usually performed?
Genetic testing has become the norm, especially with newborn screening algorithms that include it. A lot of patients do not know their specific mutations off the top of their heads but they know to ask about them.
Can you tell us a little more about the G551D mutation? Is it hard to detect?
G551D is a mutation which is included on all newborn screening and OB/GYN screening panels, thus it is not hard to detect.
In general, are CF patients with the G551D mutation affected more or less severely than those with other mutations or are they about the same?
G551D is a class 3 mutation. This class is considered to be severe since it leads to loss of function of the CFTR protein.
How will Kalydeco change CF treatment in those patients qualified to use it? Do you believe that Kalydeco could have an impact on CF life span?
I believe Kalydeco will increase CF lifespan. Unfortunately, we still do not have enough data on potential side effects. Until it is used in thousands of patients for several years, we will not know the full consequences (for better and for worse) of its action. If it is as good as we hope, it could lead to decreased need for other therapies, which would offset its cost somewhat. The pivotal study involved subjects continuing their usual medical routine, so we have no idea if the benefits seen with it will be present in the absence of other routine CF care.
The mutation occurs in about approximately 1,200 people in the US or 4% with CF, so can you try to quantify the impact that Kalydeco will have on treating the disease as a whole?
We are nibbling at the edges. Kalydeco will not affect the vast majority of CF patients. However, it does provide hope for others that their mutations may too succumb to small molecule therapy.
About Dr. Brian O’Sullivan
Dr. O’Sullivan is a pediatric pulmonologist and the Cystic Fibrosis Center Director at UMass Memorial Medical Center in Worcester, MA. He has served as Chair of the UMass Medical School IRB for the past 10 years. He co-chaired the pulmonary care guidelines committee for the National Cystic Fibrosis Foundation and has served on their Center Directors Committee.
Looking for the facts about Cystic Fibrosis and the Cystic Fibrosis market? The following information comes from our Cystic Fibrosis Market Info™ Report which is now available for purchase and download on our website, Drug Market Info.
Cystic Fibrosis Notes and Notables – Robert K. Coughlin, President & CEO, Massachusetts Biotechnology Council
Drug Market Info presents Cystic Fibrosis Notes and Notables, an interview series with leading voices in the fight to cure Cystic Fibrosis.
Today’s interview is with Robert K. Coughlin, the President & CEO of Massachusetts Biotechnology Council and the father of a son with Cystic Fibrosis. Bob is a major figure in the biotech community, a devoted father and major fundraiser for Cystic Fibrosis. He was asked to share his personal experiences and provide a perspective on drug development. Here are his comments:
Can you tell us a little bit about your son’s experience with CF and your family’s experience as caregivers?
Bobby is our third child and is currently nine years old. Our older two children were healthy and thriving. We found out in utero (21 weeks into the pregnancy) that he was affected with Cystic Fibrosis. Mom was screened for the mutation for this pregnancy and not the prior two. When we found out Mom was a carrier, I was screened and also found to be a carrier of the CF mutation. We then proceeded to test our unborn child through DNA testing of the amniotic fluid. We learned we both passed off the mutation and he would be born with CF. This knowledge enabled us to treat the disease immediately. We had the opportunity to grieve prior to him joining us and we have had a positive attitude since the beginning.
What are the daily struggles and triumphs? How do you measure or evaluate his health/progress?
Bobby’s life is not easy. He takes many meds, has trouble digesting food and struggles to gain weight. He is a very outgoing little boy that doesn’t let it hold him back. He plays hockey and baseball and loves to stay active. Overall he has been relatively healthy for a CF patient. He has only been hospitalized once for a clean out and most of his therapies we can administer at home.
On a typical day, how many medications does your son use? How much time does this involve out of his day?
Bobby often says that the worst part about having CF is the amount of time he needs to spend taking nebulized meds and receiving chest physical therapy. He gets chest PT three to five days per week. These sessions take approximately an hour for the therapist to manually “clap” various areas of his chest to loosen mucous from the lungs. He also needs to take two to three nebulized meds per day and each session takes from 30 to 45 minutes. He gets really sad sometimes when other kids are outside playing and he needs to dedicate this time to staying healthy. It is difficult for a 9-year-old, active boy to understand this but he mostly stays positive.
He has to take 3-5 pancreatic enzyme pills with every meal and snack. Some days he takes up to 50 pills per day just to eat food. These enzymes don’t work well much of the time and he has very uncomfortable abdominal pains. He also takes vitamins A, D, E, C orally as well as some other supplements. Lastly, he is on a medicine that he takes twice a day to help keep the swelling of his liver under control.
What improvements are needed in these therapies that might make them easier to take?
As parents and advocates, we always encourage the formulation of both better drugs and more efficient delivery modes. Bobby would love nebulized meds to be done “really fast” so he can get out and play. Living life is important to anyone facing chronic illness. The only pancreatic enzymes available are animal-based and deteriorate over time due to temperature changes. There needs to be a synthetic solution that can be dosed in a way to reduce the pills needed every day.
What are your thoughts on the current state of CF therapies available to patients?
We have decided to continue with manual chest PT as opposed to using a mechanical vest for this therapy. We feel that the current vests are not as effective. Until recently, most of the CF medicines were antibiotics to fight infection in the lungs. This is not a sustainable treatment due to the damage caused during infection and the bacteria’s ability to build up a resistance and stop working as the patient gets older. We have desired for many years that a synthetic enzyme be invented as well as a therapy that would fix the defect as opposed to treating the symptoms of the disease.
Do you know what CF mutation your son has? If yes, when/how did you learn of this?
My son has the deltaF508 mutation from me and the 1717-1 from his Mom. We learned of this before he was born.
How will the recent approval of Kalydeco (Vertex) change the treatment of CF for those who are able to use it?
The approval of Kalydeco is going to and is currently changing the world for patients with the G551D mutation. They may no longer be required to take all of the other therapies and hopefully the physical deterioration will be stopped in its tracks! The work is not done and we strongly support and advocate for the follow-on products that will enable Kalydeco to work for all of the CF mutations.
Do you think there are enough companies pursuing drug development for CF?
For rare diseases, there is often not enough research being done. We could argue that if there is an unmet medical need, you need to do more and more research. However, I feel that the Cystic Fibrosis Foundation has rallied with the Cystic Fibrosis community for many years to raise both awareness and research dollars. We have been and always will continue to raise money and ultimately find a cure for all who suffer from this horrible disease.
About Robert Coughlin
Bob Coughlin is President and CEO of Massachusetts Biotechnology Council. He has spent his career in both the public and private sectors, most recently serving as Undersecretary of Economic Development within Massachusetts Governor Deval Patrick’s administration. He was elected as State Representative for three terms where both healthcare and economic development were his priorities.
Bob has served as the honorary chairman of the Great Strides Cystic Fibrosis Walk and has co-chaired the Children’s Hospital Boston signature event, Champions for Children’s. His son Bobby has Cystic Fibrosis and is 9 years old.
Looking for the facts about Cystic Fibrosis and the Cystic Fibrosis market? The following information comes from our Cystic Fibrosis Market Info™ Report which is now available for purchase and download on our website, Drug Market Info.
How “The Patients’ Perspective” Helped Abbott Make Humira #1 Drug Worldwide
Humira is an exemplary example of how listening to your customers and the market makes a difference.
Here at Drug Market Info, we call that “The Patients’ Perspective.”
Perhaps we should have seen it coming even before Humira was approved by the FDA. Three months following its submission, Abbott was notified by the FDA to expect approval before the end of the year – 4 months ahead of schedule! Humira was approved New Year’s Eve 2002 and made available to patients just 13 days later – a credit to the commercialization team and the company.
Perhaps we should have taken notice that Humira was destined to be a winner given the dedication required of the marketing group during that launch as well as the disciplined pursuit of additional clinical indications by Abbott’s R & D group over the years.
Humira never had safety or efficacy advantages compared to other products in the class. What it did have was a dosing advantage that translated into convenience for patients. And this probably helped Abbott stay focused and close to their customers. It was a winning strategy for all; thousands of patients now lead fulfilled, less painful lives, and within 10 years, Humira has become the top-selling drug in the world.
We at Drug Market Info aren’t entirely surprised by Abbott’s success with Humira because we believe the key to success with pharmaceuticals lies in understanding how patients feel about and deal with their diseases and therapies. So our reports are designed to help companies assess a market with not only the relevant disease, therapeutic, market and pipeline data, but also with the critical perspective of patients. In our updated 2012 Psoriasis Market Info™ report, for the first time ever, we note that Humira prescriptions surpassed those of market leader Enbrel among dermatologists using biologics for psoriasis.
And as a final tribute to the success of Abbott, isn’t it interesting that the former market leader now appears to be tapping into what’s important to patients. Currently, Enbrel is being promoted with actual patients touting the long-term experience with Enbrel — a central concern of psoriasis patients.
Prostate Cancer Fact Sheet
Looking for the facts about Prostate Cancer and the rapidly growing Prostate Cancer market? The following information comes from our Prostate Cancer Market Info™ report, which is now available for purchase and download on our website, Drug Market Info.
What is Prostate Cancer?
Prostate cancer (PC) is a common cancer in men and the second leading cancer-related killer behind lung cancer. It is a malignant adenocarcinoma that grows as small tumors throughout a man’s prostate gland. Some tumors are indolent and require no treatment, but others are aggressive and life-threatening. Currently, there is no way to tell tumor aggressiveness and no clear guidelines about how to manage the disease, despite the launch of several new treatment options.
Most of the time (80%+) prostate cancer is discovered before it has spread beyond the prostate gland. For this reason, five-year survival is nearly 100% and 10-year survival is 91%. If metastasis has occurred, survival is considerably lower (29% at five years). For those patients with recurrences and/or advanced disease, metastasis is usually to the bone, a development that compromises quality of life, increases treatment costs and negatively affects overall survival.
Prostate Cancer: Diagnosis
Prostate Cancer generally causes no symptoms. Since the 1990s, prostate specific antigen (PSA) screening has been used to determine if a man has PC. PSA is a protein produced by cancer cells – a rising PSA level is suggestive of cancer, although there are other causes for a rising PSA. Testing is once a year for all men over age 50 (this recommendation is being questioned and may change in the future). Biopsies, along with digital rectal exams and imaging, are used to confirm if a man with an elevated PSA has prostate cancer.
If biopsies are positive for cancer, aggressiveness is rated using a scale between 2 and 10 that assesses differentiation: well-differentiated cancer is usually not aggressive and gets a low score; poorly differentiated cancers are aggressive and get high scores. These numbers are known as the Gleason Score, and it is the best available measure of cancer aggressiveness. Treatment decisions are often based to a large extent on a patient’s Gleason Score.
Prostate Cancer: US Epidemiology
Prostate Cancer (PC) is the most common non-skin related cancer in men:
- 1 of every 6 men will develop it in their lifetime
- Over 2 million in the U.S. currently have PC
- Nearly a quarter of a million men will be newly diagnosed in 2012
- 34,000 men die annually of PC – 2nd leading cause of cancer-related deaths, after lung cancer
There are 3 known risk factors for PC:
- Advancing age: PC is rare in men under age 50; common over age 80
- Race: Black men have the highest incidence in the world; Asians the lowest
- Family history: 1st degree relative doubles risk; 2+ relatives = nine-fold increase in risk
Mortality from PC has declined about 30% since 1992:
- “A man is more likely to die with prostate cancer than from it.”
- 80 is the median age of death from PC (close to average life expectancy)
- 12% percent of men die of PC after diagnosis
Prostate Cancer: Treatment
There is no universally recommended treatment for PC at any stage and many choices exist. Whether treatment should be delayed or begin immediately is controversial, especially in the earlier disease stages.
Treatment decisions depend on likelihood of disease progression and are predicated on the Gleason Score, metastasis, co-morbidities, a man’s overall health, and cancer stage at diagnosis, among other factors. If the disease is still confined to the prostate gland itself, common treatment options are:
- Radical prostatectomy
- Radiation therapy
- Brachytherapy
- Active surveillance (no treatment, but frequent ongoing monitoring with PSA levels and biopsies)
There is no clear proven benefit for any approach at this time, but regardless of option chosen, nearly 100% of patients are alive 5 years out. Men are monitored for a recurrence with PSA levels every 3-6 months.
For men in whom PC has spread or those with a recurrence, androgen depletion therapy with LHRH analogs is the standard approach. This works by depleting testosterone, which is necessary for prostate cancer growth. Over time, some men have tumors that become resistant to this approach (castrate-resistant), and require the addition of other therapies, which may include anti-androgens, immunotherapy like Provenge® (sipuleucel-T) or chemotherapy like Taxotere® (docetaxel). Many of these men do not have symptoms and have no evidence of metastasis. The length of time a man is in this castrate-resistant stage is highly variable, but once metastasis is seen (usually on a bone scan), symptoms appear. At this point, options include chemotherapy, radiation and bone-targeted therapies (which reduce bone pain and prevent fractures).
Some Interesting Facts about Prostate Cancer
- Radical prostatectomy is the most frequently chosen option as initial curative therapy for PC.
- Active surveillance (monitoring disease progression without concurrent treatment) is always an option for less aggressive cancers. Currently, fewer than 10% of men opt for this approach.
- Most men are NOT symptomatic until the last 6 mos. of their lives, which drives demand for drugs with minimal impact on quality of life.
- Unlike many other cancers, there is no interval (such as 5 years) beyond which the risk of PC recurrence is negligible, and thus, ongoing surveillance is required.
Prostate Cancer: Research
The intracellular and extracellular pathways involved with prostate tumor growth, metastasis and treatment resistance will probably require use of multiple drugs or drugs with multiple sites of activity. Since the discovery of Taxotere®, the first chemotherapy to show activity and improve overall survival against advanced prostate cancer, research in the disease has significantly expanded. Clinical trials for prostate cancer increased 30% in just two years – over 2,000 clinical trials are now in various stages with 346 in Phase 3 and nearly 900 in Phase 2.
What do Patients say about Prostate Cancer?
Here are some comments from patients:
“The secret with PC is to keep it in the prostate. You may wait and see for 3 years and now it’s outside the prostate and there is less you can do, but you could have done something 3 years back.”
“When I first started on the shots (of LHRH) I got a little tired, got hot flashes and found out what menopause is like!”
“You have to find ways to get through it. I’m 75 years old, not 30. I have aches and pains, I’m not as strong as I used to be, I have to take naps in the afternoon. How much of this cancer-related? How much medication related? How much just age-related? I think you can attribute a lot to age.”
To learn more about the ‘Patients’ Perspective,’ Drug Market Info will gladly put you in touch with patients and clinicians who can share their experiences.
Every Prostate Cancer Market Info report you purchase generates a donation to ZERO — The Project to End Prostate Cancer.
ZERO — The Project to End Prostate Cancer is committed to creating Generation Zero: the first generation of men free from prostate cancer. Zero prostate cancer deaths. Zero prostate cancer cases. Zero tolerance for prostate cancer. To accomplish their goal, ZERO provides comprehensive treatment information to patients, education to those at risk and conducts free prostate cancer screening throughout the country.
Drug Market Info Launches New Prostate Cancer Market Info™
DRUG MARKET INFO LAUNCHES NEW PROSTATE CANCER MARKET INFO™
Comprehensive Presentation-ready Report on Prostate Cancer Covers All Treatment Options and Up-to-date Market Information with Patients’ Perspectives
NORWELL, MA– March 27, 2012- Drug Market Info®, the only source for presentation-ready market reports with the Patient’s Perspective, announced today the launch of its newest research report – Prostate Cancer Market Info™. Prostate cancer is a common cancer found in men, and has the second leading cancer-related mortality rate behind lung cancer. Prostate Cancer Market Info™ is a comprehensive look at the market, including current market data, diagnosis statistics, and treatment options, as well as patient estimates by disease stage.
Prostate Cancer is a malignant adenocarcinoma that grows as small tumors in different locations throughout a man’s prostate gland. Some tumors are indolent and require no treatment, but others are aggressive and life-threatening. Currently, there is no way to tell tumor aggressiveness and no clear guidelines about how to manage the disease, or which treatment option works best. Recently, several new products for the later stages of Prostate Cancer have been launched and according to a recent Barron’s report, the metastatic prostate-cancer market could grow from approximately $1 billion to $8 billion by the end of the decade.
Prostate Cancer Market Info™ provides a comprehensive look at the market, covering epidemiology, patient estimates by disease stage, as well as unit and sales data trended for five years. As a presentation-ready report, Prostate Cancer Market Info™ is the only market analysis that contains over 100 customizable slides, 28 graphs and charts, with patient insights and perspectives woven throughout. As with all Drug Market Info reports, Prostate Cancer Market Info™ was reviewed by a leading clinician in the field to validate disease dynamics and therapeutic approaches.
“Prostate Cancer is a disease that significantly impacts men and their families with one out of every six developing the disease and over two million men in the U.S. currently living with it,” said Mary Beth Cicero, Principal of Drug Market Info. “This new report from Drug Market Info provides unique insights on the diagnosis and treatment of prostate cancer, especially since there are a variety of choices available to physicians and their patients. The Prostate Cancer Market Info™ report examines the current landscape of available treatments and pipeline products, but more importantly, spotlights how real patients weigh their treatment options and ultimately decide upon a regimen that works best for them.”
“We see over 1,000 newly diagnosed prostate cancer patients each year,” said Judd Moul, M.D., F.A.C.S. James H. Semans, MD, Professor of Surgery Director at Duke Cancer Institute. “Every man is different, so his cancer is different and his treatment choices will be, too. Therefore, it is important that a comprehensive array of treatments be available, as well as access to clinical trials and cutting-edge therapies. Drug Market Info’s comprehensive Prostate Cancer Market Info™ thoroughly covers the patients, treatments and what is in the pipeline, and is an important resource for companies looking to better understand this disease.”
Drug Market Info develops reports based on putting patients front and center. We are strong supporters of patient advocacy and our business model is built around donating a portion of our proceeds to the leading patient advocacy group in each therapeutic area we cover. Drug Market Info is extremely proud and privileged to be associated with ZERO — The Project to End Prostate Cancer. The organization is committed to creating Generation Zero: the first generation of men free from prostate cancer. Zero prostate cancer deaths. Zero prostate cancer cases. Zero tolerance for prostate cancer. To accomplish their goal, ZERO provides comprehensive treatment information to patients, education to those at risk and conducts free prostate cancer screening throughout the country. To learn more about ZERO, visit http://zerocancer.org.
“This year alone, more than 241,000 men will be diagnosed with prostate cancer and more than 28,000 will die from the disease,” said Skip Lockwood, Chief Executive Officer of ZERO. “We are seeing the death rate decrease, but we must remain vigilant in the fight against this disease by increasing research funding, raising awareness and education, and testing men with risk factors. We are pleased to be associated with Drug Market Info for making available important data on the prostate cancer market, and for showing how the disease and treatment dramatically affects the lives of men.”
About Drug Market Info (http://www.drugmarketinfo.com/)
Have you ever just wanted to understand a disease – what it looks like, who gets it, what are the treatments, which products are used and how the market is valued? Drug Market Info was founded by experienced pharmaceutical professionals who recognized the need for current, ready-to-use market information that gets to the real core of understanding a therapeutic market. Drug Market Info reports are centered around the concept of the three P’s – Patients, Perspectives and Potential with a strong focus on patient and physician insights. Our reports provide clinically accurate, up-to-date information on treating diseases such as Psoriasis, Psoriatic Arthritis, Cystic Fibrosis and Prostate Cancer, as well as how these markets are defined, sized and valued. Unique from other industry reports on the market, Drug Market Info delivers information in a presentation-ready PowerPoint format at a reasonable price. In just minutes, you can download a customizable deck of slides covering everything you need to know about a therapeutic market and the opportunities it represents. Most importantly, only Drug Market Info provides patients’ perspectives on the disease and their treatment experiences. The Company proudly collaborates with leading Patient Advocacy Groups so that every report purchased will benefit patients with the disease.
Drug Market Info – The Patients’ Perspectives and the Info You Want Now!
For Sales Information, please contact:
Mary Beth Cicero, Principal or Pamela Porter, Chief Business Officer
Call (855) DRUGMKT (378-4658)
Twitter: @DrugMarketInfo
For Media Inquiries, please contact:
Lisa Rivero
(855) 378-4658
Perfect Timing: Vertex Cystic Fibrosis Drug Approved and Cystic Fibrosis Market Info Report Now Available
Our Cystic Fibrosis Market Info™ Report, Drug Market Info’s newest market research report, is perfectly timed for analysts and drug developers to assess the impact of Vertex‘s new ground-breaking therapy for Cystic Fibrosis (CF), Kalydeco. It provides explicit disease information, the current drug armamentarium for CF, the five-year trend for the CF market value, detailed pricing and pertinent data on the CF pipeline. In addition, extensive patient input (our signature “patients’ perspective“) offers a glimpse into how CF and its treatment impacts lives. All of this supports our conclusion that the FDA approval of Vertex’s Kalydeco is a major step forward in the treatment of Cystic Fibrosis (CF) because…
- It validates genetic therapy — it is the first step toward a genetic cure for a disease caused by a faulty gene
- It treats the causes, not just the symptoms of the disease: First time ever for a CF therapy
- It could lower the high treatment burden of CF: Potentially decreases the medication load versus adding more to the pile
- It underscores the importance of collaborative agreements with the Cystic Fibrosis Foundation in this area: Kalydeco was discovered through a research collaboration with Vertex and the Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)
Maybe most importantly, this paves the way for a new research and drug development approach for any genetic disorder. Kudos to Vertex!
Sue Casarona,
Vice President,
Drug Market Info
Why do a Market Info Report on Cystic Fibrosis?
With all of the therapeutic areas where we could focus, I guess the natural question comes up why Drug Market Info would do a report on cystic fibrosis (CF). After all, the big markets like diabetes, heart disease, and cancer could be easily covered and would appeal to a larger audience. Cystic Fibrosis in this realm is tiny. With only 30,000 patients it would almost appear insignificant and falls well below the threshold of what is considered an orphan disease (<200,000 patients). Once again, we ended up being fascinated with this disease. For one thing it touched us personally. One of my best friends from college died of CF. She was a spitfire and truly lived each day as if it counted and…it did.
We also had done some work in this area by trying to help a start-up biotech company get prepared for the launch of their first drug which was for cystic fibrosis. We, of course, became totally intrigued. The disease is challenging, heart wrenching and so far incurable. The patients and their families have an indomitable spirit that we have never seen the likes of! What a beautiful (and handsome) group of patients—you can’t find a CF patient that isn’t totally adorable—both inside and out. We still don’t know or understand what makes these patients so attractive but all you need to do is look at some of the patient photographs in our report, Cystic Fibrosis Market Info™, to know what we say is true.
This disease is hopeful despite the fact that the life span of CF patients is short. The good news is they are living longer (now almost half live over the age of 18) and there are at least 30 drugs being tested in the clinic for CF. Not bad for a tiny orphan disease. Each CF patient has their own story to tell and each is as different as they can be. We talked to a father of 2 CF children, not that different in age, but they both were on each end of the spectrum as far as how their disease affected them. We want companies developing drugs to understand this and at least have a peek inside what the CF patients think about the disease and what would make a difference in their lives. It’s why we make Patients’ Perspectives one of the three sections of each and every Drug Market Info Report.
The Cystic Fibrosis market is not well-studied. The last market report we could identify was published in mid-2010, which means it was probably written a year earlier. To our way of thinking this is dated information. At Drug Market Info we like to provide the most current full year market data and all of our information is sourced and cited with the latest references (and reviewed by a leading clinician). Markets change quickly and this market is set to explode with so many drugs in clinical trials and Vertex just filing one.
Again, as with some of our other reports, we believe this market is too often overlooked from a drug development perspective in the pulmonary area. Companies are going after COPD, asthma and all of the “big” indications. But wouldn’t it make sense to do something really wonderful and make it easy for a CF patient to breathe or have less risk of infection? Even the enzymes these patients take every day could be easily improved to make life and pill taking just little bit easier for them.
What do you think? Cystic Fibrosis Market Info is a thorough and extensive report that will provide all of the insights you need to understand this market. In addition, we have partnered with the Boomer Esiason Foundation—what a great organization that is making a difference for patients! Each report you buy generates a donation to them which will help CF patients.
