Yesterday shares of Nektar Therapeutics jumped 13 percent on the news that the developer had struck a $1.5 billion licensing deal for two of its development programs with AstraZeneca. This morning its shares rose 11 percent after investigators said a small, early-stage trial of a new ovarian cancer drug produced promising results.

[ad]

Two of the five patients in the trial of NKTR-102 were evaluable for efficacy. Both demonstrated promising anti-tumor activity, with up to a 37 percent decrease in tumor size. NKTR-102 is described as a novel prodrug of irinotecan that was designed using Nektar’s proprietary small molecule advanced polymer conjugate technology platform.

“As highlighted in our data presented today at ECCO/ESMO, we continue to see encouraging signs suggesting that NKTR-102’s improved pharmacokinetics could result in an enhanced therapeutic profile,” said Lorianne Masuoka, M.D., Nektar’s chief medical officer. “We are also pleased with the rapid enrollment of the first stage of our Phase 2 clinical study in platinum-resistant ovarian cancer. Although many patients are not yet evaluable for response, we have already achieved a sufficient number of confirmed responses to open the second stage for both regimens in the study earlier than anticipated. This important new compound may offer a valuable new treatment option to overcome chemo-resistance in patients with recurrent ovarian cancer.”

Source: FierceBiotech

Popularity: 1% [?]

An FDA advisory committee voted 14 to 1 on Wednesday to recommend that the agency should not approve Johnson & Johnson and Zeltia’s Yondelis (trabectedin) as part of a combination therapy for the treatment of ovarian cancer.

[ad]

Yondelis is under review by the FDA for the treatment of patients with relapsed ovarian cancer in combination with Johnson & Johnson’s Doxil, and the panel said study data indicated that the combination of the two drugs increased the rate of cardiac problems and liver toxicities. The trial compared the use of Yondelis plus Doxil to the use of Doxil alone in 672 patients with ovarian cancer who had received treatment with at least one prior therapy.

The committee indicated that data demonstrating a six-week benefit in median progression-free survival for the combination therapy did not justify approval given the risk of the accompanying side effects.

Source: FirstWord

Popularity: 4% [?]

Data from a prospective cohort study published Tuesday in JAMA showed that menopausal and postmenopausal women who used hormone replacement therapy (HRT) had a 38-percent higher risk of developing ovarian cancer, compared with those who never used the treatments. Lead author Lina Steinrud Morch noted that the risk of ovarian cancer increases “even at durations of zero to four years.” Data showed that two to four years after discontinuing HRT, women had about the same risk as those who were not treated with the products.

[ad]

The study involved an analysis of data from several national registers in Denmark for more than 900 000 women, aged 50 to 79 years, from 1995 to 2005. During the follow-up period, which had an average length of eight years, findings showed 3068 cases of ovarian cancer. Researchers indicated that the risk of developing epithelial ovarian cancer was 44-percent higher in those who were treated with HRT, compared to those who never received treatment.

The investigators concluded that the increased risk of ovarian cancer existed “regardless of…the formulation, oestrogen dose, regimen, progestin type, and route of administration.” Nonetheless, Morch added that “despite a 40-percent increased risk…among current users of hormones, each woman will still have a very low absolute risk of developing cancer due to her hormone use.” Based on a comparison of incidence rates in current and “never users” of HRT, the analysis “approximates one extra ovarian cancer for roughly 8300 women taking hormone therapy each year,” according to the study authors.

Source: FirstWord

Popularity: 3% [?]

Sanofi-aventis announced Wednesday that the company entered into an agreement to purchase BiPar Sciences in a transaction worth as much as $500 million. As part of the deal sanofi-aventis gains access to the US biotechnology company’s potential first-in-class oncology treatment BSI-201, a Poly ADP-Ribose Polymerase (PARP) inhibitor, currently in mid-stage testing for the treatment of metastatic triple-negative breast cancer, ovarian cancer and other malignancies.

[ad]

“The acquisition of BiPar, one of the pioneers for novel tumour-selective therapies, is a further step in our company’s goal to focus on new approaches to strengthen our oncology R&D portfolio,” stated sanofi-aventis CEO Chris Viehbacher. The final purchase price of the deal, which is expected to close during the current quarter, depends on potential milestone payments associated with the development of BSI-201. Fiske analyst Peter Cartwright noted that “risk-sharing seems to be the preferred mantra for pharmaceutical executives these days.”

Helvea analyst Karl-Heinz Koch commented that “PARP inhibitors are a promising emerging new product class in the area of oncology and may improve [sanofi-aventis'] standing in what has been a traditional stronghold for the company, which is at risk of being undermined due to a lack of innovative product flow at a time of important patent losses.”

The news marks the company’s third acquisition deal this month, following agreements to purchase generic drugmakers Medley in Brazil and Laboratorios Kendrick in Mexico. The acquisitions match “perfectly…with CEO Viehbacher’s strategy to do disciplined small- and mid-sized acquisitions in the generics and biologics sector,” said Thomas Maul of DZ Bank.

Source: FirstWord

Popularity: 2% [?]

Using a blood test and ultrasound showed promise for detecting ovarian cancers at an early stage, researchers say.

It is estimated that 1,700 deaths from ovarian cancer will occur this year, according to the Canadian Cancer Society.

About 70 per cent of women with ovarian cancer are diagnosed with advanced stage disease, and their chance of long-term survival is 20 to 30 per cent, the researchers said.

Two years ago, Monique Lefebvre found out she had ovarian cancer. She was diagnosed at Stage 4, with zero being the best and four being the worst.

[ad]

“I’m considered to be very lucky to be still alive because ordinarily it’s a question of months,” Lefebvre said.

Currently, there is no effective screening test to detect the disease early.

In Tuesday’s online issue of The Lancet Oncology, researchers in the U.K. assessed the effect of two screening strategies: the CA125 blood test with transvaginal ultrasound.

The study included about 200,000 women aged 50 to 74 across the United Kingdom from 2001 to 2005. About 100,000 of those women received no screening tests.

The other half were split into two groups, with 50,000 screened with a blood test. If the results pointed to an abnormality then they also had an ultrasound.

The remaining women received only ultrasounds.

Life saving?

Among women who had a blood test first, cancer was found in 38 cases. In the ultrasound only group, 32 cases of cancer were detected.

The blood test picked up 89 per cent of the ovarian cancers (34 out of 38), compared with 75 per cent for ultrasound (24 out of 32).

Almost half of the cancers detected were at an early stage, the researchers said, compared with about 15 per cent that are normally found at that point.

“Picking up cancer early is a prerequisite to saving lives,” said Ian Jacobs, one of the study’s authors and dean of health sciences research and director of the Institute for Women’s Health at University College London. “But the question is, is this early enough?”

Costs to be weighed

Researchers won’t know if the early detection saves lives until the trial ends in 2014.

“Analysis of the psychosocial impact and cost effectiveness of these strategies is currently underway,” the study’s authors concluded.

“The results of ongoing screening are required before a conclusion can be drawn regarding the effect of screening on mortality.”

If so, experts will also have to consider whether the benefits outweigh the cost of the screening program, including whether people will have unnecessary surgeries or psychological distress, said Robert Smith, director of cancer screening at the American Cancer Society.

If the tests are offered across Canada and are done by qualified people, incidence of the deadly disease could be impacted, said Dr. Gerald Stanimir, a gynecologic oncologist at the McGill University Health Centre in Montreal.

The research was mainly funded by Britain’s Medical Research Council, Cancer Research UK and the Department of Health.

Several companies are seeking approval from the U.S. Food and Drug Administration to sell the blood tests.

Source: cbc.ca

Popularity: 3% [?]

Data from a population-based cohort study published in BMJ suggest there is “no convincing association” between use of common fertility drugs and the risk of developing ovarian cancer. Lead author Allan Jensen noted that while the findings offer “reassuring evidence for the absence of a strong association between use of fertility drugs and risk of ovarian cancer…many of the women in the study haven’t yet reached the usual peak age for developing ovarian cancer.”

[ad]

Researchers examined the medical records of 54 362 women with infertility problems who were referred to fertility clinics between 1963 and 1998, and who had used either gonadotrophins, clomifene, human chorionic gonadotrophin or gonadotrophin-releasing hormone. Average age at the first evaluation of infertility was 30 years. Over an average follow-up of 15 years, during which 156 women went on to develop invasive epithelial ovarian cancer, the authors concluded that women given common fertility treatments were not at overall increased risk of developing ovarian cancer, compared with those who had not used infertility drugs. In addition, they did not find evidence of increased risk among women who had undergone 10 or more cycles of treatment, or those who did not become pregnant.

However, a 67-percent increased risk of the most common serious subtype of ovarian cancer was observed among women who took clomifene, but researchers attributed the result to a chance association.

Jensen commented that “as many of the women in our cohort have not yet reached the usual peak age for ovarian cancer, we will continue to monitor the risk to try to establish a more definite link between use of fertility drugs and risk of ovarian cancer.” In an accompanying editorial Penelope Webb remarked that “these data are reassuring and provide further evidence that fertility drugs do not increase a woman’s risk of ovarian cancer to any great extent, although small increases in risk cannot be ruled out.”

Popularity: 1% [?]

Researchers at The University of Texas M. D. Anderson Cancer Center have identified a protein that forces ovarian cancer cells to kill themselves by cannibalism rather than via apoptosis.

An analysis of ovarian cancer tumors from 395 women showed those with high expression of the protein phosphoprotein enriched in astrocytes 15 (PEA-15) had a median survival time of 50.2 months compared with 33.5 months for women with low levels of the protein in their tumors, which marks the protein as an independent indicator of a woman’s prospects for surviving ovarian cancer.

[ad]

Removing PEA-15 from ovarian cancer cells led to a 115% increase in the number of cells compared with a control group of cells that still had the protein. The research team found that the protein works to inhibit cancer in two distinct ways depending on its location in the cell.

PEA-15 first inhibits one of the prominent actors in the growth, differentiation, and mobility of cells, a protein called extracellular signaling related kinase (ERK). Activated ERK in the cell nucleus fuels cancer growth. The research team earlier found that PEA-15 binds to ERK in the nucleus and moves it out into the cytoplasm, preventing its growth effects. PEA-15 then works in the cytoplasm itself, inducing autophagy in cancer cells.

This report appears in the November 15 issue of Cancer Research.

Source: GEN News

Popularity: 2% [?]