The fastest growing therapeutic drug classes | Conversant

Jul
16

Oncologics, lipid regulators, respiratory agents, antidiabetics and anti-ulcerants are the five largest drug classes by sales. But annual sales are only half the story. Which drug classes are booming, and which have plateaued–or even dropped? IMS Health has released top-line industry data revealing the 15 largest drug classes, and we’ve crunched the numbers to take a closer look at the average sales growth of the 15 largest therapeutic classes over the last five years.

Though oncologics are the biggest overall market, with $52.37 billion in 2009 sales, they are the second-fastest growing therapeutic class. Autoimmune agent sales have been increasing at a faster overall pace for five years straight, averaging almost 18 percent annual growth. This category includes blockbuster biologics–like Remicade, Enbrel and Humira–that treat a wide variety of immunological diseases. On the opposite end of the spectrum are the classes whose market is shrinking. Erythropoietins (such as Aranesp, Epogen and Procrit) experienced strong growth until 2007. Sales of the drugs dropped 20 percent in a single year following safety warnings that the class caused heart and vascular problems at higher doses.

- see the article and chart on the fast growing drug classes
- and check out this chart on the top 15 drug classes of 2009

Read more here.


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Researchers find Biomarker for early detection of oral cancer

Jul
15

Researchers have discovered a biomarker called human beta defensin-3 (hBD-3), which may help in early detection of oral cancer.

Oral cancer first appears as white or red lesions in the mouth, the same as non-cancerous lesions.
Early detection is difficult to detect, until it spreads to other organs.

HBD-3 is only found in the basal layer where oral cancers grow and is present when the cancerous tumour progresses. The study revealed that it assists the cancer growth.

The researcher plans to continue studying the role of hBDs in oral health and to develop diagnostic tools that use the biomarker to detect early cancer.

The research is published in PLoS ONE. For more, read here.


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Novelos revives failed lung cancer drug

Jul
14

After suffering a serious setback when NOV-002 flunked a late-stage clinical trial for lung cancer earlier this year, Novelos says the same drug proved effective in combination with chemotherapy during a small Phase II trial for breast cancer. But the news failed to inspire much hope among disillusioned investors. Its shares (NVLT) were trading at 14 cents this morning.

“We are excited about this proof of concept trial and we are excited to have NOV-002 back in the game,” Novelos CEO Harry Palmin said yesterday. The breast cancer trial enrolled 39 patients and tested if the preoperative use of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel could at least double the complete response rate. Palmin added that the company would discuss the outlines of a bigger placebo trial with the FDA.

Back in February shares of Novelos were hit hard after the Newton, MA-based Novelos announced that NOV-002 had failed a late-stage trial for lung cancer. The biotech company shelved that program a month later.

- check out the Novelos release
- here’s the story from the Boston Business Journal and John Carroll


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Team looks to microbubbles for cancer drug delivery

Jul
13

Ultrasound scanners often rely on tiny, gas-filled bubbles to sharpen the images they capture. But certain ultrasound signals are known to burst those bubbles. And now a cross-disciplinary team of researchers at Leeds University will explore whether the phenomenon can be put to use as a new drug delivery tool.

The investigators initially plan to load the bubbles up with tiny amounts of well known chemotherapy drugs to determine if they can nail down the kind of basic proof-of-concept data they need to demonstrate the promise of the delivery technology. Then they plan to widen their research horizon to include other drugs, including a novel drug now in development for colorectal cancer.

“A number of research teams are looking at possible uses for microbubbles, but with the breadth of expertise available at Leeds we’re in a good position to make a breakthrough,” Professor Stephen Evans tells The Engineer. “For the technique to be a viable clinical and commercial option, we not only need to find a reliable way to attach the drugs and antibodies, we also need to be able to manufacture the bubbles in sufficient numbers, of the right size and with consistent properties.”

“The ultrasound wave makes the bubbles resonate, vibrate and finally burst. By changing how we code the electrical excitation signal, we can image and verify how many bubbles are at the site to ensure we administer the right drug dose before we burst them,” says Professor Steven Freear. “This means we can use ultrasound, not only to detect and image the microbubbles but, critically, to rupture them, delivering the drug payload in a controlled way.”

- here’s the article from The Engineer
July 7, 2010 — 10:19am ET | By John Carroll


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New ‘smart bomb’ tech used to target cancer cells

Jul
12

A team of researchers from Australia and India are hard at work developing a new “smart bomb” to target tumors. The investigators are developing an antibody that binds to cancer stem cells, delivering a lipid particle containing an anti-cancer therapy coupled with RNAi gene silencing tech.

“While current treatments kill the bulk of the cancer cell, the cancer root escapes the therapy and can regenerate into a new cancer mass,” says Wei Duan, an associate professor at Deakin University, who is collaborating with colleagues in India on the project. “The aim of our research is to develop a smart bomb that can penetrate the cell and release the drugs within the cells, rather than from the outside, and kills the whole tumor, root and all.”

Indian Institute of Science in Bangalore, Barwon Health’s Andrew Love Cancer Centre and ChemGenex Pharmaceuticals are all collaborating on the program, which has been funded in part by the Indian and Australian governments. And the scientists say the delivery technology isn’t restricted to the cancer field. The same approach could also work for Alzheimer’s, heart disease and diabetes.

“This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects,” says Duan.

- here’s the story from the Sydney Morning Herald
- here’s the report from The Med Guru


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New Research Model of Human Prostate Cancer Shows Cancer Development

Jul
09

New Research Model of Human Prostate Cancer Shows Cancer Development

ScienceDaily (July 1, 2010) – Progress toward understanding the role of sex hormones in the growth of prostate cancer — the most common cancer in U.S. men — has been hindered by the lack of a suitable laboratory research model. Now researchers say they have developed the first model of hormone-induced human prostate cancer initiation and progression.

Their results were presented at The Endocrine Society’s 92nd Annual Meeting in San Diego.

“We hope this model will speed up the process of testing preventive therapies for prostate cancer as well as help clarify the hormonal mechanisms in the development of this cancer,” said Gail Prins, PhD, a professor and reproductive physiologist at the University of Illinois at Chicago, who is a co-author of the study.

“Sex hormones — testosterone and estrogens — are involved in regulating the growth of prostate cancer, but the mechanisms are not well established,” Prins said.

Currently the only available laboratory models of human prostate cancer are xenografts — cancerous human tissues grafted under the skin of animals — or “transformed” cancer cell lines containing cells that originally came from patients with prostate cancer. However, Prins said, “If you want to study the initial development of cancer — either naturally or induced — or its prevention, you cannot use a model of existing cancer, such as transformed cell lines.”

To study the progression of prostate cancer from normal cells into cancerous cells requires the use of animal prostate cells. Animal models, however, do not directly mimic all aspects of human prostate cancer, experts say.

Prins and her colleagues created their model using prostate cells obtained from a deceased organ donor who did not have prostate disease. They isolated and grew, in 3-D culture, adult prostate progenitor cells — cells with stem cell-like properties that self-renew and may become cancerous. In 3-D culture, the progenitor cells proliferate and form small spheroids, called prostaspheres, which are capable of regenerating tissues.

The researchers combined these human prostaspheres with embryonic cells from the prostate of a rat and then transplanted the mixed cells under the kidney capsule of mice. These transplants regenerated into normal human prostate-like tissues and secreted prostate-specific antigen (PSA), which confirmed human functionality, according to Prins.

The mice then received a drug pellet containing testosterone and estradiol estrogen. A cancerous tumor formed at the transplant site.

“We were able to induce hormonally driven prostate cancer in these recombinant tissues,” Prins said. “Using this model, we can follow the entire pathway of the cancer — from normal tissue to initiation and progression.”

Read more here.

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Blood cells can generate stem cells, studies show

Jul
08

Researchers have successfully reprogrammed human blood cells into embryonic-like stem cells according to three news studies. Experts say this has the potential for changing the course of stem cell research.

Three years ago, researchers in Japan and the United States announced they had taken a simple skin cell – inserted four viruses, which reprogrammed the blood cells to an embryonic stem-cell like state and a source of embryonic-like stems cells. These cells are called induced pluripotent stem cells (IPS cells) and are believed to have the ability to turn into any cell in the body, just like embryonic stem cells, but without the controversy of destroying an embryo, which happens when embryonic stem cells are removed from the embryo.

This week, three groups of researchers report having generated IPS cells from blood. The studies were published Thursday in the journal Cell Stem Cell.

The benefit of using IPS cells is that eventually, doctors could take a patient’s skin cells and make IPS cells from it and any therapies made from these cells wouldn’t be rejected because they have the same DNA as the patient. But first the patient has to undergo a skin biopsy for scientists to get the skin cell, which can be cumbersome, costly and sometimes cause some side effects.

However, drawing blood is much easier than taking a skin biopsy. Researchers in Japan used as little as 1 ml of blood (=0.03 ounces). Plus, researchers can take advantage of already drawn blood. Scientists from the Whitehead Institute for Biomedical Research in Cambridge, Massachusetts, used frozen blood. This opens up more research possibilities because scientists could use blood stored in tissue banks and study the diseases of people who may have moved away or passed on.

The goal of IPS cell research is to “transfer the disease into the test tube” says Dr. Rudolph Jaenisch, a founding member of the Whitehead Institute and stem expert. He says it wasn’t easy making IPS cells from blood, but having the ability to do so now will allow researchers to have easy access to a widely available source for generating IPS cells. These IPS cells will have all the genetic alterations that have contributed to the illness of a patient. Jaenisch says researchers can now grow nerve cells or other cells that are affected by a disease like Parkinson’s and study the progression of disease.

Dr. John Gearhart, who heads the University of Pennsylvania’s Institute of Regenerative Medicine , says these three papers “are quite important to the IPS field.”  He says being able to make IPS cells from blood will be much more practical for patients and researchers.

Dr. Shinya Yamanaka led one of the two teams that made the first human IPS cells from skin cells. He writes in an accompanying article for the journal, that the three studies “represent a huge and important progression in the field.”

Here is the full story.


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Cancer Stem Cells Are Not ‘One Size Fits All,’ Lung Cancer Models Show

Jul
07

Cancer stem cells have enticed scientists because of the potential to provide more durable and widespread cancer cures by identifying and targeting the tumor’s most voracious cells. Now, researchers at Children’s Hospital Boston and their colleagues have identified cancer stem cells in a model of the most common form of human lung cancer and, more significantly, have found that the cancer stem cells may vary from tumor to tumor, depending upon the tumor’s genetic signature.

“Our study shows the cancer stem cell hypothesis is true in some lung cancers,” said senior author Carla Kim, PhD, an assistant professor in the Stem Cell Program at Children’s Hospital Boston and the department of genetics at Harvard Medical School (HMS). “It also shows, from one lung cancer to another, the cancer stem cells are not the same.”

Cancer stem cells are a subset of cancer cells believed to elude conventional treatments and eventually regenerate a tumor. Experimentally, they show up as cells that can be extracted from a tumor and transplanted to form a new tumor, from which the same tumor-propagating cells can again be extracted and transplanted with the same result. According to Kim, this is the first serial transplantation study to identify lung cancer tumor-propagating cells….

Find the full story here.


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U.S. FDA panel explores boost for rare drugs

Jul
06

U.S. regulators are exploring how to make it easier and cheaper for drug companies to develop treatments for rare diseases — an underserved slice of the market that typically offers slim profits.

The U.S. Food and Drug Administration already offer companies grants and guaranties seven years of market exclusivity for drugs that treat rare diseases.

The agency is looking to find other ways to encourage drugmakers through its new rare disease review group, which holds its first public hearing on Tuesday and Wednesday.

Any disease that affects fewer than 200,000 patients is classified as rare, and one in 10 people in the United States lives with such a disease. However, the FDA has approved a treatment for less than three percent of rare diseases.

“So if you get one of these diseases, God bless you,” Senator Sam Brownback, whose amendment created the FDA review committee, said at a Senate hearing last week.

The new rare disease review group is part of a broadened effort to encourage companies to spend more money on the more than 6,000 rare diseases identified, including relatively well-known conditions like cystic fibrosis and Huntington’s disease.

More than 350 drugs to treat rare diseases have been approved since the FDA launched an orphan drug program in 1983, compared with fewer than 10 such products approved the decade before.

Yet the pharmaceutical industry still spends little on rare diseases, due to high drug development costs and low profits, especially in contrast to blockbuster cholesterol or heartburn drugs that bring in billions of dollars.

The FDA says it is sensitive to companies’ bottom lines.

“Even if you have very targeted and effective product development, it does cost real money and people will expect a return on investment,” said Jesse Goodman, chief scientist and deputy commissioner for science and public health at the FDA.

The Biotechnology Industry Organization, which represents more than 1,200 biotech companies, wants to see more funding and incentives within the orphan drug program.

Sara Radcliffe, BIO’s executive vice president for health, said in comments submitted to the committee that in Europe, orphan products receive 10 years of market exclusivity. “Given its importance, we urge consideration of a longer U.S. exclusivity period to coincide with Europe,” she said.

Companies and advocates also say that drugs for rare diseases should not have to go through as many clinical trials as other drugs. These drugs often have fewer potential test subjects, making it more expensive to coordinate and harder to meet the same scientific standards.

Read the full story by Jon Lentz here.


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Frozen blood a source of stem cells, study finds

Jul
02

(Reuters) – Frozen blood from stored samples can be used to make cells resembling stem cells, researchers said on Thursday — opening a potential new and easier source for the valued cells.

They used cells from blood to make induced pluripotent stem cells or iPS cells — lab-made cells that closely resemble human embryonic stem cells but are made from ordinary tissue.

These iPS cells have in the past been made from plugs of skin, but blood is much easier to take from people and to store, the researchers reported in the journal Cell Stem Cell.

“Blood is the easiest, most accessible source of cells, because you’d rather have 20 milliliters of blood drawn than have a punch biopsy taken to get skin cells,” Judith Staerk of the Whitehead Institute for Biomedical Research in Massachusetts, who worked on the study, said in a statement.

Stem cells are the body’s master cells, the source of renewed blood and tissue. So-called adult stem cells exist through life but they are partially developed.

Embryonic stem cells from days-old embryos have the ability to become all the cell types in the body and also can proliferate in the lab for years.

IPS cells are made by activating three or four genes that distinguish embryonic stem cells.

Whitehead’s Rudolf Jaenisch, who directed the work, said being able to use blood will open opportunities for researchers who want to use iPS cells to study how diseases develop.

“There are enormous resources — blood banks with samples from patients that may hold the only viable cells from patients who may not be alive any more, or from the early stage of their diseases,” Jaenisch said.

“Using this method, we can now resurrect those cells as induced pluripotent stem cells. If the patient had a neurodegenerative disease, you can use the iPS cells to study that disease.”

(Reporting by Maggie Fox; Editing by Julie Steenhuysen)


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