New drug may stop spread of breast cancer

Researchers have identified a new compound that completely halts the spread of metastatic breast cancer in mice.

The vast majority of deaths from cancer result from its progressive spread to vital organs such as the brain and lungs – a process known as metastasis.

In a recent series of studies researchers identified a previously unknown critical role for a potential cancer causing gene, Bcl3, in metastatic breast cancer.

“We showed that suppressing this gene reduced the spread of cancer by more than 80 per cent,” said Dr Richard Clarkson from Cardiff University’s European Cancer Stem Cell Research Institute.

“Our next goal was to then find a way to suppress Bcl3 pharmacologically. Despite great improvements in therapy of early stage breast cancer, the current therapeutic options for patients with late stage metastatic disease are limited.

“There is therefore a clear unmet clinical need to identify new drugs to reverse or at least to slow down disease progression,” he added.

Clarkson and his team joined up with researchers Dr Andrea Brancale and Dr Andrew Westwell from the Cardiff University School of Pharmacy and Pharmaceutical Sciences, to develop small chemical inhibitors of the Bcl3 gene.

Computer aided modelling of how the Bcl3 gene functions inside the cell allowed the group to identify a pocket on the surface of Bcl3 essential for its function.
By screening a virtual compound library for chemicals that could fit inside this pocket, using state-of-the-art computer software, they identified a drug candidate that potently inhibits Bcl3.

The compound was then trialled on mice with metastatic disease. The resulting effect was that the drug completely inhibited the development of the mice’s metastatic tumours.
Researchers are now working to conduct clinical trials of the compound. The aim is to develop a therapeutic agent capable of blocking metastatic disease in breast cancer and a variety of tumour types.

Source: Business Standard

Biocon to start selling breast cancer drug in India in February

Biocon Ltd said its generic version of Roche’s Herceptin breast cancer treatment would be available to patients in India from the first week of February.

Bangalore-based Biocon jointly developed biosimilar trastuzumab, which received the Indian drug regulator’s marketing approval in November, with U.S.-based Mylan Inc.

About 150,000 people are diagnosed with breast cancer every year in India, of which 25 percent are eligible for treatment with trastuzumab, Biocon said.

Roche decided not to pursue a patent application for its breast cancer drug Herceptin in India, paving the way for generic drugmakers to produce cheaper copies, known as biosimilars because they are not identical to the original drug.

Global sales for Herceptin were valued at about $6.4 billion in 2012, including about $21 million in India, Biocon said.

Source: Reuters

AbbVie drug shows promise against difficult type of breast cancer

Patients with so-called triple negative breast cancer appeared to have double the response rate to the regimen containing AbbVie’s veliparib in a new type of study

Women with an especially deadly type of breast cancer who received a treatment regimen containing an experimental AbbVie Inc drug prior to surgery are likely to have a significantly better response than those who get a standard chemotherapy regimen, according to data from a clinical trial.

Patients with so-called triple negative breast cancer, who tend to be younger and have a very poor prognosis, appeared to have double the response rate to the regimen containing AbbVie’s veliparib in a new type of study that exploits advances in molecular understanding of the disease, researchers found.

The trial dubbed I-SPY 2 is another step toward developing more personalised treatments. Its design allows researchers to continuously monitor how patients respond as the trial progresses and move patients into arms of the study testing drugs from which they are more likely to gain benefit.

This type of trial should help companies select the right group of patients to enroll into larger, more traditional late stage clinical trials, potentially cutting the cost of bringing new medicines to market.

Drugmakers are under increasing pressure to cut the cost of new medicines that put a huge burden on healthcare systems. One way to do that would be through more efficient, alternative testing methods that lead to fewer trial failures.

“It’s a very nimble trial design that allows you to enroll a fairly small number of patients and come to a fairly high certainty of success (in later larger trials) in a specific subset of patients,” explained Dr. Hope Rugo, who presented the data at the San Antonio Breast Cancer Symposium on Friday.

If a drug combination starts to look like it is working better on patients with one type of breast cancer, the trial design allows for more patients with that type of cancer to move into that arm of the study, said Rugo, director of breast oncology and clinical trials education at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco.

The US Food and Drug Administration, which signed off on the trial design, has said that if a study drug helps cure significantly more cancers, it could be given a provisional type of accelerated approval.

Faster development, reduced cost

“If we can get a better idea of who benefits early, it’s going to be an enormous change in the way we test new agents, and not just for breast cancer but for other malignancies as well,” Rugo said.

“You could avoid doing a 3,500 patient trial in a group of patients who you thought might benefit but don’t,” she said. “We’ll be able to get the drugs to the patients who need them much more quickly and at reduced cost.”

The I-SPY program is testing a variety of experimental medicines from several drugmakers in the neoadjuvant, or pre-surgery, setting in high-risk patients. Rugo was presenting the portion of the trial that involved the AbbVie drug.

In that arm of the study involving 71 high risk patients, the researchers were testing to see whether the treatment, given before surgery, could eliminate any evidence of invasive cancer in breast tissue and lymph nodes removed during subsequent surgery – a measurement known as pathologic complete response (PCR).

They found an estimated PCR in 52 per cent of women who were treated with AbbVie’s veliparib plus the chemotherapies carboplatin and paclitaxel. That compared with a 26 percent PCR rate in those who just got standard paclitaxel. Both groups also received anthracycline-based chemotherapy prior to surgery.

“If we can increase the number of patients who have no invasive cancer, we expect that this will translate into better survival,” Rugo said.

Most breast cancer tumors are estrogen-receptor positive, fueled by the hormone estrogen. About 20 per cent are HER2-positive, meaning a protein called HER2 is prevalent. A third type is driven by the hormone progesterone. All of these have potentially effective treatment options even after recurrence.

Triple-negative tumors – about 15 per cent of breast cancers – lack estrogen, progesterone or HER2 receptors needed for most drugs to work. If the tumor does not respond to chemotherapy, there are currently no alternatives and the typical survival rate after recurrence is less than two years.

More women treated with veliparib and carboplatin dropped out of the study due to side effects, whereas discontinuations in the control arm were primarily due to disease progression.

Rugo said she looked forward to further study of the AbbVie drug, noting that the trial design did not separate which effects were due to veliparib and which to carboplatin.

However, she said, the doubling of response rates was “very encouraging to us and suggests that veliparib is playing an important role in the enhanced response that we’re seeing.”

Source: Khaleej times