Rethinking the Lengthy Path of Cancer Drug Development

The average drug takes eight years to develop and costs more than $800 million, according to a new study performed at the Tufts Center for the Study of Drug Development in Boston.

Shift from traditional drug development to the most promising biopharmaceuticals developed via living cells, and that average cost skyrockets to $1.2 billion.

As one might expect, drug companies are both bogged down by the lengthy research process, as well as concerned by the massive funds required to pay for prescription drug medication. To add to the high financial costs, keep in mind that bills that amount to millions of dollars don’t just apply to successful drugs – but the countless failures as well.

For as long as anyone can remember, the pharmaceutical industry has operated on this linear, trial-by-error method. Now, in an effort to streamline the entire process to save both time and money, industry luminaries are diligently seeking more sustainable paths.

One such project, based out of the Massachusetts Institute of Technology (MIT), is gaining interest among both federal health authorities and for-profit drug manufacturers. Known as the New Drug Development Paradigms, the MIT program’s short-term goal is to identify sources of bottlenecks in the current drug development process.

While this can be dramatically helpful, MIT also hopes to develop long-term solutions by creating new prediction models, streamlining communications about the biology of diseases, and improving inclusion that allows for earlier participation from patients, health care providers and regulators.

The ideas are intriguing, but may be met with some resistance from those who are accustomed to the current process. For example, MIT suggests that medical companies work with each other by sharing information about compounds that they have given up on due to safety or other issues. For an industry that is tied to proprietary knowledge and profits, this may be a tough pill to swallow.

However, it is because drug companies do not share information on early stage dead-end projects that different research groups routinely head down the same path (eventually finding only the same dead-end). Perhaps the idea of saving millions from investments in previously disproved technologies will be enough to spur cooperation.

Another program that MIT has initiated, in conjunction with Harvard Business School, is a system called Pharmer’s Market. This online tool uses crowd-sourcing to predict the probability that a drug will succeed. The program, which was just initiated last month, has calculated the success rates of several cancer drugs currently in clinical trials. If time proves these predictions correct, medical companies may be able to pinpoint which drugs are most likely to succeed so that they can maximize research funds.

Resource:

http://www.nytimes.com/2009/11/15/business/15stream.html?_r=1&em

http://www.biospace.com/news_story.aspx?NewsEntityId=158671

Targeted Delivery of Nanoparticles Improve Precision of Chemotherapy

Nanoparticle delivery systems can be used to dramatically improve the precision of chemotherapy administration, according to a study performed at the University of California-Irvine.

Currently, cancer medications suffer from a weak targeting system. Oftentimes, chemo drugs are disseminated throughout the body, attacking both cancerous and healthy tissue. Due to this unfocused attack, cancer-fighting agents that actually attack the tumor are often not enough to adequately destroy the invading cancer cells.

To improve precision, UC Irvine researchers looked at nanoparticles as a potential means for targeted drug administration. Specifically, the team used a unique amino acid sequence that targets liver cells. When added to a nanoparticle delivery system and injected intravenously, the drug nearly exclusively targeted liver cells while ignoring other organs in the body.

The new technique has the potential to greatly improve the effectiveness of cancer treatment. More over, chemotherapy treatments may also be engineered to be much safer, with fewer side effects displayed by the patient.

While initial studies were conducted on liver tissue, the IC Irvine team is confident that the procedure could be incorporated universally, regardless of tumor location. As the team points out, all cell types exhibit unique polysaccharide segments that might be targeted through the use of engineered nanoparticles.

Additionally, nanoparticles should even be able to specifically target cancer cells within a particular organ. As head researchers at UC Irvine Dr. Richard Robertson and Dr. Kenneth Longmuir explain, “Tumors are surrounded by polysaccharides. The composition of these polysaccharides appears to be different compared to normal tissue. The next step in our investigation is to develop amino acid sequences that specifically recognize polysaccharide compositions found in tumors, but not in normal tissue.”

Fatigue, hair loss, skin sores and many other cancer side effects are the direct result of chemotherapy drugs attacking healthy cells. Thanks to this focused approach, cancer patients may one day experience a dramatic reduction in side effects.

Resource:

http://www.newuniversity.org/2009/10/news/advances-in-chemotherapy-dramatically-increase-precision/

New Drugs May Help Make Healthy Cells Immune to Radiation

Research indicates that suppression of a particular gene may help protect healthy cells and tissue from damage caused by cancer radiation treatments. The findings, reported by researchers at the University of Pittsburg (in collaboration with the National Cancer Institute), are considered as a major breakthrough in cancer research.

The majority of cancer patients are treated with radiation therapy. The success of such therapy is often limiting, given the fact that such treatments have the potential to harm healthy cells as well as cancer cells. Now, this new discovery has the potential to yield safer, more effective drugs.

The breakthrough was somewhat of an accidental discovery. The University of Pittsburg happened upon the finding while investigating gene treatments related to heart disease and high blood pressure. In the course of this research, they found that the suppression of a particular gene resulted in cell immunity to cancer radiation.

To test the effectiveness of their happy accident, the team purposely blocked the biochemical signaling pathway that expresses this gene in pigs and mice. To their surprise, the healthy cells exhibited immunity even to the highest doses of radiation.

Just as surprisingly, the radiation treatments appear to be more effective at killing cancer cells. As it turns out, the same gene suppression that safeguards healthy gene also reduces the defenses of cancer cells.

Currently, radiation treatment has a number of side effects due to healthy cell death. These include fatigue, hair loss, skin sores and vomiting. By minimizing the potential damage to healthy cells, cancer treatment in the future may not only be more tolerable, but more effective as well.

As Dr. Jeff Isenburg, leader of the study, reports, “this dramatic protective effect occurred in skin, muscle and bone marrow cells, which is very encouraging.”

Dr. David Roberts, from the National Cancer Institute, adds: “In our experiments, suppression of CD47 robustly delayed the regrowth of tumors in radiation-treated mice.”

The promising early findings may lead to viable human treatments is as few as five years. In the mean time, further research must be enacted to better understand how exactly the suppression of CD47 protects healthy cells. Additional testing is also required on lab animals before clinical trials will begin.

Resources:

http://www.telegraph.co.uk/science/science-news/6397540/Cancer-breakthrough-as-treatment-protects-healthy-cells-from-radiotherapy.html

http://health.usnews.com/articles/health/healthday/2009/10/21/radiation-treatments-made-safer-for-cancer-patients.html

U.S. Expands Partnerships of United States-Latin America Cancer Research Network

Partnerships dedicated to intensifying cancer research as it relates to Latin American populations were recently forged between the United States and four Latin American countries – Argentina, Brazil, Mexico and Uruguay.

The partnerships serve to greatly expand the United States-Latin America Cancer Research Network (US-LA CRN), an international program created by the U.S. National Cancer Institute (NCI), a division of the National Institutes of Health (NIH).

NCI director John E. Niederhuber, M.D., who acted on behalf of the U.S. government by signing letters of intent “to collaborate in cancer research efforts”, formalized the partnerships. The four Latin American countries, along with previous partner Chile, will join forces with the United States to gain an improved understanding of cancer prevalence and cancer deaths in Latin America.

Dr. Niederhuber sees the coalition as more than just a symbolic stance against cancer. As he states, “by electronically linking cancer research data, cancer researchers in Latin America and the United States will be able develop new knowledge of cancer trends — from individual communities to large populations.”

The US-LA CRN lists three fundamental goals of this partnership:

1. Improve the knowledge base of cancer research, burden of disease and cancer care infrastructures in Latin American countries

2. Foster partnerships across Latin American countries to enhance cancer research efforts

3. Improve necessary resources for cancer treatment and research within Latin American countries

Both U.S. and Latin American officials expressed hope that this partnership would result in improved cancer research as it pertains to Latin populations. With a centralized database of DNA banks and cancer information systems, researchers in all participating countries will have access to a larger pool of data for research purposes.

Pilot programs for the US-LA CRN will focus on breast cancer management, as well as improving research training and building long-term clinical research infrastructure.

Cancer is one of the top three deadliest illnesses in Latin America. Given the high population of Latin Americans in the United States, the U.S. sees such a coalition as an important step in future cancer management. Some estimates predict that 60 million Hispanics will be living in the U.S. by 2020 – a number that would comprise 19 percent of the nation’s total population.

Resources: http://www.cancer.gov/newscenter/pressreleases/ArgentinaBrazilMexicoUruguayUS

http://www.cancer.gov/aboutnci/olacpd/page4

Australian Union Workers Fight for Asbestos Safety, Monitoring

Recently, an auction house (Pickles Auctions) located in Canberra, Australia was shut down due to improper removal of asbestos products. The closure was deemed necessary after it was determined the removal of the asbestos was both unauthorized and improperly performed.

The news was brought to the government’s attention through the Construction, Forestry, Mining and Energy Union (CFMEU), who is authorized to enter worksites to investigate potential worker health hazards or safety breaches.

However, under new laws currently being considered by the Canberra government, union inspection of such sites could be made more difficult. As the present proposed laws stand, the CFMEU organizers who spoke up against improper safety at Pickles Auctions could have been prosecuted.

Sadly, Canberra government officials recently voted in favor of drafting tougher auditing laws as they pertain to unions. Though no knew laws have been enacted yet, surely this would be a major blow against worker safety in Australia.

Asbestos is a naturally occurring product that has been used in building insulation and many other commercial products. When inhaled, asbestos can cause mesothelioma.

The CFMEU is currently arguing against the proposed monitoring restrictions. Additionally, they are calling for the government to enact an asbestos register that would track individuals who have been exposed to asbestos. The goal of such a register is to document and track initial exposures so that workers can more easily seek fair compensation if mesothelioma does occur later in life.

Resource: http://www.abc.net.au/news/stories/2009/10/20/2718784.htm

http://www.abc.net.au/news/stories/2009/10/30/2728284.htm

Texas Investing $3 Billion in Cancer Research

Texas has passed legislation to invest $3 billion into cancer research and prevention over the next ten years. The staggering sum makes the Lone Star State the second-largest source of cancer research funding in the United States. Only the National Cancer Institute (NCI) doles out more dollars (last year NCI awarded $3.14 billion in grants; an additional $1.26 billion has been set aside through the federal stimulus bill).

The beginnings of the deal go back to 2007 and the creation of the Cancer Prevention Research Institute of Texas. At the time, Texas Governor Rick Perry campaigned heavily to get Texans to vote for the package. The bill passed, and now the first wave of grants will be awarded next spring.

The money serves as a considerable boom to cancer researchers. Texas authorities say the money will be used largely for the development of new drugs, as well as high-risk research programs that have been turned away elsewhere.

The state also plans to use some of the money to attract leading scientists to Texas and to create the first statewide clinical trial network. $2 million alone has been set aside to pay for salaries and research for top researchers.

The money will serve to bolster Texas’ already considerable efforts in cancer research. The state serves as home for both the Susan G. Komen for the Cure Foundation and Lance Armstrong Foundation. One of the nation’s top cancer research facilities – the University of Texas M.D. Anderson Cancer Center in Houston – is also located there.

In a time of significant economic downturn, some experts are worried that Texas won’t be able to deliver the projected funds. Dr. Tyler Curiel, executive director for the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, worries “that [the] $3 isn’t in the bank. What if the money isn’t going to be there in the future?”

Indeed, financial woes of the state have already hinted at potential problems down the line. Funding for the first two years is already $150 million short. However, officials believe the money will be recouped later in the program.

In relation to other state cancer initiatives, nothing comes close to Texas’ planned funding. California voters approved a $3 billion package to fund stem cell research, but court battles related to the ethics of such studies have so far stymied grant money.

Under the provisions of the program, $260 million will be devoted to cancer research for each of the ten years. An additional $30 million will go towards cancer prevention services annually.

While big hopes are being pinned on the grant money, major breakthroughs are likely not to occur in the near future. As Dr. Alfred Gilman, chief scientific officer for the Texas institute explains, ” (We’re) not going to bring new drugs to market during the first two years. Nor during the first four years.”

Still, though progress may be slow, researchers, oncologists and patients are hopeful that the huge influx of funding could one day lead to, as Republican Rick Perry puts it, a day when “we talk about cancer the same way we talk about polio.”

Resource: http://www.google.com/hostednews/ap/article/ALeqM5iL-RvOcK4xaPgnNGSSyJkEui_RvAD9B34E280

Mesothelioma in Pets Can Provide Insight Into New Treatments

Mesothelioma is a rare type of cancer that accounts for approximately one percent of all cancer deaths worldwide. The cancer is caused through the inhalation of asbestos – a naturally occurring fiber that is often used for insulation or heat-resistant purposes.

Just as asbestos exposure affects human health, so too does it affect the health of pets and companion animals. In rare cases, asbestos exposure among dogs and cats does occur. Sadly, such exposure may eventually lead to mesothelioma.

Prolonged breathing problems, coughing or difficulty breathing witnessed in a dog or cat may be warning signs of mesothelioma. If a family member works around asbestos, fibers may remain on their clothing when they come home. These fibers may be inhaled or licked by the pet. Additionally, asbestos has been commonly used in building construction, and may be present in home walls.

When mesothelioma in pets occurs, it is of course a tragedy. However, these pets may serve as important pioneers in new mesothelioma treatments. Oftentimes, these dogs and cats undergo experimental mesothelioma treatments that may one day be approved for use in humans.

One such study, reported in the May 2008 issue of the Journal of Experimental & Clinical Cancer Research, found promising results for a mesothelioma treatment regimen that combined the use of piroxicam and platinum-based intracavity chemotherapy.

Three companion animals took place in the study – two dogs and one cat. All participants experienced variable remission times. Most notably, one dog continues to be in remission three years following treatment. This is incredibly promising, given the fact that most human patients to do not survive more than a year following a mesothelioma diagnosis.

The other dog survived for eight months following treatment, while the cat survived 6 months. While this is less encouraging, treatment did result in a 90 percent reduction in excessive fluid buildup.

The researchers who published the paper suggest that the treatment results are promising enough to warrant future tests in animals, and possibly humans. However, they note that mesothelioma is more likely to follow a benign course of advancement in dogs than in humans. This may be a hidden factor in the 3-year survival time of the one canine participant.

Resources:

http://www.jeccr.com/content/27/1/6

Georgia Senators Urge OSHA to Issue Combustible Dust Regulations

On February 7, 2008 an Imperial Sugar refinery exploded in Port Wentworth, Georgia, killing 14 workers and injuring dozens more. The cause of the explosion was combustible dust.

Following the disaster, OSHA representatives were chastised during a hearing at the House Education and Labor Committee for their apparent lack of concern about protecting U.S. workers from the dangers of combustible dust. At the time, OSHA stressed that they were assessing whether or not regulatory action was necessary to create standards for combustible dust in the workplace.

More than a year later, it seems OSHA is still unmotivated to address the topic. OSHA recently announced its regulatory agenda for the next year, and apparently there are no plans to propose a rule for combustible dust.

Rather, OSHA indicates a pre-rulemaking notice will be issued instead. A pre-rulemaking notice is supposedly requested when more information on a subject is required. However, many suggest these pre-rule notices are nothing more than a placeholder for actual progress in worker safety. Rather than propose actionable changes, OSHA simply “requests more information” to skirt the issue.

Now, it seems Georgia’s senators would like to see more action from OSHA on the issue of combustible dust. Recently, both Senator Johnny Isakson and Saxby Chambliss publicly urged OSHA to officially release regulations regarding this dangerous work hazard. Based on briefings of the Imperial Sugar explosion compiled by the Chemical Safety Board, Senator Isakson had this to say:

“I believe we should embrace the findings of the Chemical Safety Board, including the recommendation that OSHA establish mandatory standards modeled after the National Fire Protection Association guidelines. Sen. Chambliss and I are working closely with Secretary Solis to ensure that the lessons we have learned as a result of the Port Wentworth disaster will help us prevent future tragedies.”

OSHA will be releasing its most recent version of its regulatory agenda in December. Only time will tell whether the additional pressure from these Georgia legislators will prove effective.

Resources:

http://thepumphandle.wordpress.com/2009/09/28/waiting-for-osha-to-disappoint-on-combustible-dust/

http://www.osha.gov/dsg/combustibledust/index.html