Monthly Archives: August 2005

Musicians Honor Dylan in Benefit for Oral Cancer Foundation

  • 8/30/2005
  • April Karys
  • US Newswire

When Dan Roth’s lifelong friend and fellow musician called with an idea to do a benefit music concert-and told Roth he could pick the cause-the decision came naturally: Roth, a two-time oral cancer survivor, chose oral cancer awareness.

“It was kind of a no-brainer for me because of how much the Oral Cancer Foundation has helped me,” Roth said. “I use their Web site a whole lot.”

Roth, 36, is a resident of Sea Cliff, Long Island. But he grew up about six miles away, in Williston Park, going to school and playing drums with his friend, guitarist Greg Schochet, now a professional musician in Boulder, Colorado.

“We grew up playing music in the basement,” said Roth, a drummer. When the boys were in seventh grade, Schochet’s father played the music of folk legend Bob Dylan for them. From then on, the boys were diehard Dylan fans. So it’s no surprise that when Schochet decided years later to pull the musicians of Boulder together for a themed evening of music, it should be a tribute to Dylan, held on the famed musician’s birthday.

“I was out there for a visit about a year before that,” said Roth. “And one day we sat around playing Dylan songs for hours and hours. He said ‘Next time you come out, let’s play a gig.’ Then he called up a few weeks later and said ‘I have a better idea. Why don’t we make it a benefit, and you can choose the beneficiary.’”

Roth immediately thought of the Oral Cancer Foundation, a Newport Beach, CA-based nonprofit organization whose online forums and bountiful resources helped him through two bouts with oral cancer. Roth remembers well the process of his diagnosis.

“I was at the dentist and they didn’t really even notice,” he said. “But I felt what I thought was a canker sore. And the hygienist said, ‘Oh wow, your throat’s really red.’ And I just kind of blew it off.” Three weeks later, the sore had not healed, and spicy food was causing Roth considerable pain. He made an appointment with an ear, nose, and throat doctor who immediately ordered a biopsy.

“The biopsy was positive,” Roth said, adding that his initial cancer was caught at Stage 3. “He wanted to remove most of my tongue. I immediately got a second opinion, which lead to a surgical removal of the cancer.”

Roth, who neither smokes nor drinks, was puzzled about why he’d gotten oral cancer-until he learned that smoking and drinking are just two risk factors for the disease. An emerging cause of oral cancer in non-smokers is the Human Papilloma Virus. Unlike the incidence of oral cancer from smoking which usually occurs in the 5th and 6th decades of life, oral cancers created by this virus occur frequently in young people. Surgery held Roth’s cancer at bay for 14 months.

“When it came back, it came back on the roof of my mouth, which is weird I guess–but they caught it so early because I was going every month to get checked. The second time they caught it, it was Stage 1 or less.” That time, Roth underwent radiation treatments, which ended in October of 2004.

“It’s tough to get through the radiation,” Roth admitted, adding that he relied on the interactive survivor and caregiver forums on the Oral Cancer Foundation’s Web site for support, information, and encouragement. There he was able to talk with others who were either experiencing the same disease issues or talk with those who had been through it before and were survivors.

Roth said he’s honored that the musical community rallied to his chosen cause. “It was a great event,” he said. “We thought Dylan would be the hook that would draw people in-and it hooked all the local bands. Everyone thought it was a great idea. And everyone knows someone who’s had cancer. It really worked out well.”

At least five bands, and a total of 42 performers showed up to play Dylan songs at the Boulder Theater on May 24. All the musicians donated their time and played for free.

“The musical community here in Boulder is pretty amazing,” said Schochet. “I’ve played in a whole host of bands over the years, and they all are friends with each other. We’ve put together a lot of different benefit shows, and I’ve participated in easily half a dozen of them. The nights are always super-fun. It’s not just a regular concert: it’s people doing things they don’t normally do, in different configurations.”

Given their history of musical philanthropy, getting the musicians to play at no charge was the easy part, said Schochet, who besides rallying the musicians, secured the venue, arranged for a concession, rented equipment, and took on the countless other projects that go into producing a benefit event.

“A lot of the musicians jumped at the chance to come play Dylan songs—I could have got them to come play a benefit for Oral Cancer Foundation with no problem, but the Dylan part just made them want to come out all that much more.”

Bands included Halden Wofford and the Hi-Beams, Runaway Truck Ramp, Hit & Run Bluegrass, Rose Hill Drive, Jeff Austin & Adam Aijala, and numerous solo, duo, and other acoustic acts. There was even a Dylan sound-alike contest. The event drew a crowd of 500 to 600 people, a large gathering for a Tuesday night.

“We sent the Oral Cancer Foundation a check for $3,440,” said Schochet, who says he plans to produce the concert again next year. “It was more than I’d hoped we would raise.”

OCF founder and oral cancer survivor Brian Hill said “ These individuals gave of themselves to benefit strangers they will never meet. That type of altruistic behavior isn’t something that you find every day.” These talented people, and particularly Schochet and Roth, pulled this off on their own initiative showing what can be done if your hearts in the right place. I am very grateful that they chose to associate a wonderful event like this with the oral cancer cause, and the foundation in particular. We can only accomplish the goal of reducing the death rate from this disease if we work in synergy with others. These musicians have furthered that goal, and in the process of giving back, touched the lives of literally thousands of people that have heard about their effort. We can’t thank them enough.”

The bands raised more than just money for the Oral Cancer Foundation: they raised awareness about a disease that strikes all too often, is recognized far too infrequently, and disrupts lives the world over. For that, survivor Dan Roth is happy. Roth’s checkups keep coming back normal. And he continues work he’s serene about: He’s half-owner and graphic designer at Roth Advertising, a three-person company his father started in 1971. And in May, Roth and his wife, Kathleen, welcomed a baby into their world. The little boy’s name? Dylan.

August, 2005|OCF In The News|

Advocate Good Samaritan Hospital in Chicagoland First to Offer Tomotherapy for Cancer Treatment

  • 8/30/2005
  • Downers Grove, IL
  • press release
  • U.S. Newswire (releases.usnewswire.com)

Advocate Good Samaritan Hospital’s Cancer Care Center is offering the only Tomotherapy Unit in the Chicago/Metropolitan Area. This cutting edge technology is the most precise radiation therapy available for cancer patients and is currently available at only one other site in Northern Illinois (Zion, Ill.)

Tomotherapy is a way to create precision with radiation by combining imaging for patient positioning with advanced intensity modulated radiation therapy (IMRT). What does this mean to each patient? More accurate treatment, fewer side effects and decreased time commitments for patients.

“Tomotherapy marries a CT (computerized tomography) scan with a radiation treatment machine, advancing accuracy of treatment”, explains Michael Stutz, M.D. “Because we are imaging the tumor prior to each radiation treatment, we can ensure that our treatments are on target every day.”

William Hartsell, M.D. explains: “Tomotherapy is ideal to treat tumors that are next to important normal structures that should be spared from the radiation–such as treating prostate cancer to spare the rectum and bladder; head and neck cancer to spare the salivary glands; and brain cancer to spare as much normal brain as possible.”

The media is invited to a press conference on September 6, from 10 a.m. to 11 a.m. William Hartsell, M.D., Michael Stutz, M.D., Director of the Cancer Care Center, Paula Timmerman, a radiology technician and possibly a patient about to undergo treatment will be available for questions and comments. Media will also be able to view the new equipment.

August, 2005|Archive|

Addition of Erbitux® to Radiation Improves Survival in Head and Neck Cancer

  • 8/30/2005
  • staff
  • CancerConsultants (cancerconsultants.com)

A recent phase III trial indicates that the addition of the targeted agent Erbitux (cetuximab) to radiation therapy improves survival in patients with advanced head and neck cancer.

Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx and other sites throughout the head and neck area. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage, or extent to which the cancer has spread, as well as the specific locations within the head or neck area where the cancer has spread. The patient’s overall medical condition is also a deciding factor. Treatment typically consists of radiation therapy, chemotherapy with surgery or surgery alone. Once head and neck cancer has spread from its site of origin, long-term outcomes are generally suboptimal. In addition, treatment for head and neck cancer often results in a compromised quality of life. Research and development of newl therapeutic approaches that will improve long-term outcomes and quality of life for patients with this disease continues.

The epidermal growth factor receptor (EGFR) pathway is involved in this research. This biologic pathway plays a role in cellular replication and is often over expressed in cancer. Erbitux, a monoclonal antibody (or protein), has been produced in a laboratory with the purpose of binding to the EGFR and inhibiting the receptor’s effects on cellular replication. Erbitux is currently FDA-approved in combination with irinotecan for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy. The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan. Erbitux is currently being evaluated in clinical trials for the treatment of various types of cancers.

Recently results from a large phase III trial (phase of trial prior to FDA review) referred to as IMCL-9815) were analyzed by an Independent Clinical Review Committee (ICRC). This trial included 424 patients with advanced head and neck cancer whose cancer had spread throughout the head or neck region. Patients were treated with radiation therapy alone or radiation therapy plus Erbitux. Patients treated with radiation plus Erbitux showed significantly improved survival and progression-free survival times over those treated with radiation alone. Furthermore, the addition of Erbitux to radiation helped prevent the spread of cancer beyond the head and neck region more effectively than radiation alone. The data from these results will be presented in an upcoming scientific meeting.

Researchers concluded that the addition of Erbitux to radiation therapy improves overall survival, progression-free survival and controls the spread of cancer more than radiation therapy alone in patients with advanced head and neck cancer. Patients with advanced head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating Erbitux.

Reference:
ImClone Systems. Independent Clinical Review of Phase III Trial Shows Erbitux and Radiation Control Spread of Advanced Squamous Cell Cancer of the Head and Neck Better Than Radiation Alone; Primary and Secondary Study Endpoints Met with Statistical Significance. Available at:
http://phx.corporate-ir.net/phoenix.zhtml?c=97689&p=irol-news.

August, 2005|Archive|

Predicting Response of Head and Neck Cancer to Accelerated Radiation Therapy

  • 8/30/2005
  • staff
  • CancerConsultants (cancerconsultants.com)

According to a study published in the Journal of Clinical Oncology, patients with head and neck cancers are more likely to benefit from accelerated radiation therapy if a high proportion of their cancer cells have receptors for epidermal growth factor, a growth factor that plays a role in cell proliferation and survival.

Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck include cancers of the nasal cavity and sinuses, mouth, and throat. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread.

Among head and neck cancer patients receiving radiation therapy, one reason for treatment failure is the accelerated regrowth of cancer cells that can occur during fractionated radiation therapy (radiation therapy that is split into smaller doses and administered over the course of several days). To overcome this problem, researchers have investigated accelerated radiation therapy schedules. According to these schedules, higher daily doses of radiation are given over fewer days. Some patients may be more likely than others to benefit from these accelerated schedules. One factor that may influence patient response to different radiation therapy approaches is the presence of epidermal growth factor receptors (EGFR) on cancer cells. Epidermal growth factor plays a role in cell proliferation and survival, and cancer cells are more likely than normal cells to have receptors for this growth factor.

In order to determine whether patients with higher levels of EGFR are more likely to benefit from accelerated radiation schedules than patients with lower levels of EGFR, an international group of researchers assessed 304 head and neck cancer patients. They had participated in a randomized clinical trial of accelerated versus conventional radiation therapy. Among patients with lower levels of EGFR, there was no benefit of accelerated radiation therapy compared to conventional radiation therapy. Among patients with higher levels of EGFR, however, those who received accelerated radiation therapy were less likely to have persistent or progressing cancer than those who received conventional radiation therapy.

The researchers conclude that EGFR expression on cancer cells influences response to radiation therapy. Head and neck cancer patients with high EGFR levels appear to benefit from accelerated radiation therapy. Recent research has also evaluated the combination of radiation therapy with the EGFR-blocking drug Erbitux® (cetuximab) among patients with advanced head and neck cancer. These results are promising (http://patient.cancerconsultants.com/head_cancer_news.aspx?id=34402).

Reference:
Søren MB, Atasoy BM, Daley FM et al. Epidermal growth factor receptor expression in pretreatment biopsies from head and neck squamous cell carcinoma as a predictive factor for a benefit from accelerated radiation therapy in a randomized controlled trial. Journal of Clinical Oncology. 2005;23:5560-5567.

August, 2005|Archive|

Merck KGaA Submits Erbitux Head, Neck Cancer Data for Approval

  • 8/30/2005
  • Frankfurt, Germany
  • press release
  • Bloomberg News (bloomberg.com)

Merck KGaA, which owns non-U.S. rights to ImClone Systems Inc.’s Erbitux cancer treatment, submitted to regulators new data on the drug’s ability to treat head-and-neck cancers, aimed at boosting its sales in Europe.

It submitted its application to the European Medicines Agency and the Swiss regulator Swissmedic, the Darmstadt, Germany-based drugmaker said today in an e-mailed statement. ImClone and its marketing partner Bristol-Myers Squibb Co. have applied to the U.S. Food and Drug Administration to extend the drug’s use in the U.S.

Merck KGaA Chief Executive Bernhard Scheuble, who negotiated European rights to the drug from ImClone in 1998 for $60 million, aims to widen its use beyond colon cancer, for which it’s approved in Europe and the U.S. Merck’s sales from Erbitux came to 94 million euros ($115.5 million) during the first half of the year, compared with the 77 million euros it generated in all of 2004, its first year on the market.

Erbitux is approved for patients whose bowel cancer has spread and who aren’t benefiting from other treatments. The drug was approved in Europe and the U.S. on the basis of phase II clinical data that showed its ability to shrink tumors. Three phases of studies are generally required for regulatory approval.

Difficult to Treat

The additional sales potential from head-and-neck cancers, which are notoriously difficult to treat, is lower than for other cancer types, Groschke said in an Aug. 29 telephone interview. “This indication is significantly smaller than colon cancer,” he said.

Head-and-neck cancers are often caused by tobacco and alcohol. They occur in cells lining the mouth, nose and throat, the tongue and other parts of the head including the brain, and account for as much as 5 percent of all cancers in the U.S., according to the National Cancer Institute.

Merck KGaA, which is not affiliated to the U.S. drugmaker Merck & Co., has begun a series of late-stage studies to obtain evidence that the drug can increase chances of survival as well as shrink tumors.

The company said in June that data from a study of 21 patients showed that Erbitux helped to prolong the lives of colon cancer patients by an average 33 months, almost a year longer than patients on chemotherapy alone. It was the first data to demonstrate the drug’s ability to prolong lives.

The medicine belongs to the same class of medicines as Genentech Inc. and OSI Pharmaceutical Inc.’s lung cancer drug Tarceva.

August, 2005|Archive|

Study Could Help Tailor Treatment for Head and Neck Cancer Patients

  • 8/29/2005
  • Denmark
  • staff
  • The Lancet Oncology, August, 2005 reported by Newswise.com

Danish scientists have identified which head and neck cancer patients will benefit from additional drug treatment during radiotherapy, in a paper published online today by The Lancet Oncology.

Tumours that have low concentrations of oxygen (hypoxia) are resistant to radiotherapy. A drug called nimorazole (a hypoxia radiosensitiser) can improve the outcome of radiotherapy for patients with these types of tumours. However, at the moment there is no way to identify people with tumours that lack oxygen, who need this additional drug treatment, from those that only need radiotherapy.

Researchers knew that the concentration of a protein called osteopontin was associated with tumours that lacked oxygen. Jens Overgaard (Aarhus University Hospital, Denmark) and colleagues assessed whether blood concentration of osteopontin could predict patients’ responses to nimorazole. The investigators measured the concentration of osteopontin in 320patients on a trial comparing nimorazole and radiotherapy with placebo and radiotherapy. Patients were grouped into high, intermediate, and low concentrations of osteopontin and the team recorded their outcome. They found that patients with high concentrations of the protein assigned placebo had a poorer prognosis than those with high concentrations on nimorazole.

Professor Overgaard states: “. . . high plasma concentration of osteopontin predicted clinically relevant, modifiable hypoxia-induced resistance to radiotherapy, and this finding might help to identify patients who will benefit from treatment with a hypoxia modifier such as nimorazole during radiotherapy. By contrast, use of nimorazole was not effective in patients with low or intermediate plasma concentrations of osteopontin.”

August, 2005|Archive|

Time to spit out today’s cancerous role models

  • 8/29/2005
  • editorial
  • Heraldnet (www.heraldnet.com)

Perhaps country singer Gretchen Wilson is confused by her status as a role model; it doesn’t mean she should model how to roll a wad of chewing tobacco into her lower lip.

For her recent tobacco promotion, the country singer is now joining an ever-expanding group of not-so-worthy pop idols. Wilson, 32, a role model among teenage females who frequent her concerts, has been flashing a can of chewing tobacco to the crowd during her recent performances of new song “Skoal Ring,” a song simply about the wonders of chew.

Glamorizing chewing tobacco to an audience of impressionable young fans goes a long way to undermine every anti-tobacco campaign created to convince youths to avoid the cancer-causing habit. On stage, Wilson’s gestures with her small can of tobacco may seem innocent and playful, but they can be detrimental.

The female population has been a growing victim of lung cancer for decades. About 21 percent of U.S. females are smokers, according to the Center for Disease Control and Prevention, far from the U.S. goal of cutting the number of smokers to 12.5 percent by 2010. Lung cancer rates increased 600 percent among women in the second half of the 20th century, and deaths from lung cancer now significantly outnumbers deaths from breast cancer.

Smokeless tobacco, a more glamorized, if shocking, form of ingesting tobacco, will only continue this trend. This stiff-lower-lip form of tobacco ingestion dramatically increases a person’s chance of getting oral cancer.

Unfortunately, Wilson isn’t the only popular image to be making lousy impressions on adolescents.

The continued, incessant glamorizing of cigarettes in movies, is just part of the problem. Paris Hilton gets famous with an infamous video and simple life, Hugh Grant is caught with a prostitute, sports stars are using steroids and illicit drugs – the list of big name figures making poor decisions seems to be growing in newspaper headlines.

None of these actions should slide without condemnation. Tennessee Attorney General Paul Summers has taken swift aim at Wilson for her in-concert displays, a move that will help put a dark shadow on Wilson’s lower lip. Parents have a role in this culture also, letting kids know that the actions of an idol may not be that actions of a role model.

At least that will give kids something to chew on.

August, 2005|Archive|

Delta launches fight to treat oral cancer in Detroit

  • 8/26/2005
  • Detroit, MI
  • Sharon Terlep
  • Detroit News (www.detnews.com)

A test done with a device that’s essentially a toothbrush can help fight oral cancer — one of the stealthiest, deadliest and costliest cancers plaguing minorities in Metro Detroit.

The simple test, called a brush biopsy, can detect oral cancer long before it takes hold, saving patients’ lives and sparing them costly medical bills. Oral health care experts hope the test will become as prevalent as mammograms, which have become a key to early detection of breast cancer.

Many of those most at risk for oral cancer don’t know an exam exists, however. Delta Dental Plans of Michigan and the Detroit Oral Cancer Prevention Project have teamed up on a regional campaign to encourage people, especially African-American men, who are at the highest risk for the disease, to get oral cancer tests.

“It’s a stealth problem that no one talks about,” said Amid Ismail, director of the Detroit Oral Cancer Prevention Project and University of Michigan professor of dentistry. “It is unacceptable that the problem of oral cancer is not publicly known in Detroit.”

Oral cancer kills about 30,000 Americans a year and is especially prevalent in Detroit. The city each year ranks among the top five metropolitan areas for oral cancer rates. Smoking, drinking alcohol and exposure to ultraviolet rays are all risk factors for oral cancer.

Donald Jones worried for weeks because his tongue was changing color. The 66-year-old Detroiter decided to get a test, which was negative, after seeing a billboard about oral cancer.

“I had no idea even that oral cancer existed,” Jones said.

During the test, a dentist uses a toothbrush-like device to scrape tissue from inside a patient’s mouth that is then tested for cancer. Delta Dental Plans of Michigan is spending $50,000 to cover brush biopsies and other exams and treatments for uninsured Wayne County residents.

Patients will receive a screening from the Detroit Dental Assessment Center. Depending on the results, patients may then be referred to volunteer dentists.

Okemos-based Delta Dental, which insures 5.1 million people in Michigan, Ohio and Indiana, is trying to promote tests among dentists, as well. The insurer is among few that reimburses patients for brush biopsies.

If oral cancer is caught early, the cure is simple removal of diseased tissue. In later stages, treatment consists of disfiguring surgeries that can cost more than $200,000. The survival rate drops to 57 percent from 81 percent when the disease is not detected early.

August, 2005|Archive|

Oral cancer; the evidence for sexual transmission

  • 8/26/2005
  • England
  • C. Scully
  • British Dental Journal (2005); 199, 203-207

The incidence of oral cancer amongst young adults is increasing in many European and high incidence countries. Most oral cancer is aetiologically linked to the use of tobacco and/or alcohol but nearly two decades ago, we produced the first evidence for the presence of viral nucleic acids in oral squamous cell carcinoma (OSCC) tissues, hypothesising that there may be a viral involvement in at least some OSCC.

Subsequently, human papilloma viruses (HPV) in particular have been implicated in OSCC. Antibody responses to HPV are seen and HPV-DNA detected in tumours by us and many others, the virus being mainly HPV-16, the genotype associated with ano-genital cancer. Recent studies have indicated that HPV may be aetiologically important particularly in some types of oropharyngeal cancer, at least in tonsillar carcinogenesis, and may represent an alternative pathway in carcinogenesis to the established factors of tobacco and alcohol. Studies of patients with OSCC have suggested possible sexual transmission of HPV.

Author’s affiliation:
Dean, Director of Studies and Research, Eastman Dental Institute for Oral Health Care Sciences, University of London, 256 Gray’s Inn Road, London, WC1X 8LD

OCF Note: Welcome to the 21st century doctors….OCF reported peer reviewed articles with this conclusion more than a year ago.

August, 2005|Archive|

Therapeutic cancer vaccines

  • 8/26/2005
  • Hampshire, England
  • Fleur Pijpers, Richard Faint & Nish Saini
  • Nature Reviews Drug Discovery 4, 623-624 (2005);

Unmet needs across the oncology market remain high, with most traditional therapies representing a trade-off between levels of specificity, efficacy and toxicity. The development of therapeutic cancer vaccines, designed to confer active, specific immunotherapy directed against tumour-associated antigens (TAAs), could be the ideal solution for the successful eradication of some cancers. Cancer vaccines offer the prospect of high specificity, low toxicity and prolonged activity. However, although there is a solid technical and scientific rationale behind the development of vaccines, this theory has yet to be consistently translated into clinical practice and, to date, most cancer vaccines have been associated with high rates of clinical failure. Beyond scientific hurdles, the relative immaturity and lack of precedence in the cancer vaccine market has also brought to light an entirely new spectrum of clinical, regulatory and strategic challenges.

Challenges in an unprecedented market

From a clinical perspective, cancer vaccines are most likely to complement current oncology therapies rather than serve as replacements. However, some cytotoxics have known immunosuppressive properties, and therefore the optimal scheduling of chemotherapy administration needs to be defined in order to avoid compromising the activity of therapeutic cancer vaccines.

The design of clinical trials for cancer vaccines and the regulatory assessment of vaccine technologies raise additional issues: as a result of their mode of action and hypothetical prolonged antitumour activity, the optimal assessment of cancer vaccines might require a shift away from the established endpoint designations that have been used to evaluate traditional oncology therapies. For example, prolonged disease stabilization might be a more relevant endpoint to the design of cancer vaccine trials than any measurement of tumour regression. For this reason, and given our understanding of tumour growth kinetics, cancer vaccines are more likely to demonstrate clinical benefit in the setting of minimal residual disease rather than in metastatic disease. Developers, however, seem reluctant to re-focus their efforts on the former, because demonstrating clinical benefit will require a longer and subsequently more costly patient follow-up than is required in the setting of more advanced disease.

Coordinated efforts between the major global regulatory bodies and cancer vaccine researchers will facilitate the development of relevant assessment criteria of patient response that can be reproducibly applied to the design and evaluation of technologies in ongoing clinical development. It has been widely suggested that immune monitoring might constitute a viable response criterion for the assessment of cancer vaccines, although optimal methods for measuring this have yet to be developed.

Current pipeline

The current cancer vaccine market is characterized by a dearth of approved products, although a dynamic and dense pipeline is set to change this. With at least 78 agents in clinical development and the involvement of at least 64 companies, the market is wide open. Although regulatory procedures for cancer vaccines need adapting, the first product to reach the market will smooth the way forward for all those behind it and overcome the associated challenges.

Classification of vaccine technologies

Three-quarters of the current cancer vaccine pipeline comprises ‘generalized’ or ‘off-the-shelf’ vaccines that are based on specific carbohydrates, proteins or other easily replicated structures that are capable of being mass produced. The remainder consist of ‘personalized’ or autologous vaccines; these are based on antigens harvested from individual patient’s tumour cells. This trend reflects the ease of manufacture and economies of scale achievable with generalized vaccines.

The ‘generalized’ and ‘personalized’ vaccine classifications can each be further subdivided into one of three types: polyvalent, antigen-specific and dendritic-cell-based approaches; and within the first two categories further sub-classifications of vaccine type can be defined. Antigen-specific cancer vaccines dominate all phases of clinical development, constituting 63% of the R&D pipeline. Their dominance is secondary to their perceived higher specificity, ease of production, lower cost of manufacture and reduced levels of concern related to product contamination.

Despite this trend, it is unclear what class of vaccine is likely to dominate the future vaccine market, if any. ‘Generalized’ vaccines, in part a result of their limited range of ‘relevant’ antigen expression, have been associated with a higher rate of clinical failure than ‘personalized’ approaches.

To date, despite concerns related to the complexity of manufacture and formulation, as well as post-production sterility and distribution concerns, it is has been a ‘personalized’ dendritic cell-based vaccine strategy that has provided the most compelling clinical evidence. Dendreon’s Provenge constitutes patient-specific dendritic cells loaded with a TAA (prostatic acid phosphatase), and is the only vaccine to date to demonstrate a survival benefit in a large-scale randomized trial for prostate cancer, despite not meeting its primary endpoint of time to progression.

Commercial rewards dictate focus

The ‘big four’ tumour types of breast, prostate, colorectal and lung cancer remain commercially attractive indications for developers because of their high patient potential and commercial value. Furthermore, melanoma and renal-cell carcinoma are also the focus for developers, given their tractability to immunotherapy. However, it is the haematological tumours such as leukaemia, lymphoma and myeloma that are perhaps the ideal target indication owing to their anatomical location, which facilitates the access of vaccine-generated immune-effector cells.

Future focus

There are many aspects of commercializing cancer vaccines that will require developers, regulators and clinicians to collaborate on an unprecedented level to expedite the delivery of these new therapies to patients. One of the single biggest challenges will be to bring together the keepers of disparate intellectual property — for example, vaccine-delivery technologies, immune adjuvants and formulation techniques — and combining these pools of expertise to produce effective cancer vaccines with broad clinical application. On the basis of forecast peak sales and the assumption that the most promising Phase III pipeline candidates are granted marketing approval, Datamonitor estimates that the potential worth of the therapeutic cancer vaccine market will be US$633 million by 2014.

Market indicators

The current cancer vaccine market is highly fragmented, and comprises at least 78 clinical development agents. At present, 18% of these pipeline candidates are in Phase III clinical trials or pre-registration, whereas 33% and 49% are in Phase II and Phase I clinical trials, respectively. The pipeline is dominated by antigen specific cancer vaccines.

At least 64 companies are involved in clinical R&D, 80% of which are small biotechnology firms. Strategic collaborations with established oncology players will expedite the path to market by providing the marketing and development expertise, as well as financial resources, necessary to negotiate the unique clinical, strategic and regulatory challenges that the commercialization of cancer vaccines presents. However ‘big pharma’ still needs convincing that vaccines are a risk worth backing. The success of one or two cancer vaccines will stimulate the formation of developmental partnerships.

Using epidemiology-based forecast peak sales and the assumption that the most promising pipeline candidates in Phase III clinical trials are granted marketing approval, we estimate that the market could be worth US$633 million by 2014.

Authors’ affiliations:
Fleur Pijpers, M.Eng., is an Oncology Analyst, Richard Faint, M.B.A., Ph.D., is Lead Oncology Analyst and Nish Saini, Pharm.D., is a Senior Oncology Analyst at Datamonitor Healthcare, Charles House, 108–110 Finchl

August, 2005|Archive|