Human Genome Sciences says that a combination of Velcade and its experimental cancer drug mapatumumab (HGS-ETR1) flunked a mid-stage trial for multiple myeloma, with the data failing to demonstrate an improvement over Velcade alone.

“The results showed no difference in disease response or progression-free survival for the combination that included mapatumumab vs. the control group receiving bortezomib alone, and showed that mapatumumab was well tolerated in this study,” HGS said in a statement. The antibody was expected to induce cancer cell death by activating the TRAIL receptor 1 protein.

Another Phase II trial is currently underway to evaluate mapatumumab’s potential in combination with Nexavar (sorafenib) for advanced hepatocellular cancer. The drug also failed a mid-stage study for lung cancer in March. But the fresh stumble in its cancer program didn’t have much impact on the developer’s shares, which rose slightly this morning. Analysts are primarily interested with HGS’s lupus drug Benlysta, which has megablockbuster potential.

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Popularity: 2% [?]

FDA cleared Novartis’ Zortress® for the prevention of organ rejection in adult kidney transplant patients at low-to-medium immunologic risk. The drug is indicated for administration in combination with a reduced dose of the cyclosporine basiliximab and corticosteroids. U.S. approval comes with a Risk Evaluation and Mitigation Strategy (REMS) to help guide safe use of the drug following kidney transplantation.

Zortress is already available under the Certican® trademark in over 70 countries outside the U.S. for kidney and/or heart transplant patients, Novartis notes.  Global sales of the drug were $118 million in calendar year 2009, up 31% on 2008 sales. The Zortress active ingredient, everolimus, is also undergoing Phase III testing in heart transplant patients to support an additional U.S. filing. A worldwide Phase III liver transplant trial is also ongoing.

FDA approval of Zortress was based on data from what Novartis calls the largest single Phase III trial ever conducted in kidney transplant patients. The study showed Zortress therapy prevented acute organ rejection and preserved kidney function while allowing a 60% lower dose of cyclosporine when compared with treatment using mycophenolic acid combined with full-dose cyclosporine and corticosteroids.

The firm says that it now offers five transplant medicines. Neoral/Sandiummun was Novartis’ eight top-selling pharmaceutical in 2009, achieving sales of $919 million (down 1% in local currencies). The transplant medicine Myofortic was also in the company’s top 20. At position 18, it achieved sales of $353 million, up 28% on 2008.

Zortress/Certican is an oral inhibitor of the mTOR pathway. The drug is also available under the brand name Afinitor® for the treatment of advanced renal cell carcinoma after failure of therapy using Sutent or sorafenib. Afinitor was approved in the U.S., Europe, and Switzerland in 2009.

Phase III trials in other cancers are also under way or due to start this year. In Novartis’ annual report for 2009, the firm said that two potential everolimus regulatory submissions are planned for 2010 based on the outcome of clinical trials in patients with neuroendocrine tumors or those suffering tuberous sclerosis complex.

Source: GEN News

Popularity: 4% [?]

Dozens of cancer studies may be thrown into doubt by the discovery that researchers inadvertently used the wrong type of cancer cells.

The “cell lines”, according to the Journal of the National Cancer Institute, were supplied as samples of oesophageal cancer.

However, tests show they contained other types of tumour, including lung and bowel.

The Dutch researchers say this could put major trials of drugs in doubt.

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Many experimental studies on cancer use laboratory-grown “cell-lines”, meaning that dozens of studies may rely on cells originally taken from a single patient.

New drugs can be tested on these cells to see if they have an effect before they are tested on real patients.

The problem of “false” – or contaminated – cell lines, is not a new one, and there have been calls for scientists to take more care verifying they have the right sort of cells before continuing with their experiments.

If not, they run the risk that their findings, positive or negative, may be misleading.

The latest example of the problem involved samples widely supplied as oesophageal adenocarcinoma cells, a particular type of cancer affecting the gullet which carries food from the mouth to the stomach.

In fact, they came from tumours of the lung, bowel and stomach, said researchers from the University Medical Centre in Rotterdam.

They wrote: “Experimental results based on these contaminated cell lines have led to ongoing clinical trials recruiting patients, to more than 100 scientific publications, and to at least three cancer research grants and 11 US patents – which emphasises the importance of our findings.”

Widespread use of these cell lines could threaten the development of new treatments, they said.

In particular, use of the drug sorafenib for some oesophageal cancer patients should be reconsidered, since the wrong cell line was used to assess its potential.

Specialist suppliers

However, writing in the same journal, Professor Robert Shoemaker of the National Cancer Institute in Maryland, said he suspected that a similar study using the right cell lines would support the use of sorafenib.

In the UK, one of the main funders of cancer studies, Cancer Research UK, has said that it uses DNA testing to check its cell lines.

The Health Protection Agency also operates an extensive cell culture collection and a spokesman said it urged scientists to, where necessary, pay for tests to check their cell lines.

He said: “The use of wrongly identified human cancer cell lines is a problem that was first recognised more than 20 years ago.

“We draw attention to this danger on our website, which includes an ever-expanding list of those cell lines known to be incorrectly identified, or cross-contaminated with a cell line of a different type.

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“As a national culture collection we, together with other national collections, exhort research scientists to always work with authenticated cell lines of known provenance.”

Source: BBC NEWS

Popularity: 4% [?]

Bayer and Onyx reported preliminary results from a mid-stage study on Wednesday which showed that Nexavar (sorafenib), in combination with Roche’s Xeloda (capecitabine), significantly extended progression-free survival in patients with advanced breast cancer, compared to Xeloda alone. Lead investigator Jose Baselga remarked that “one goal of this study was to evaluate the success of an all-oral regimen, which may represent a unique treatment option for patients with breast cancer.” Onyx shares rose as much as 24.3 percent on Wednesday.

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The randomised trial involved 229 patients with locally advanced or metastatic HER-2 negative breast cancer who had received no more than one prior chemotherapy, and who were given either Nexavar or placebo twice daily, plus treatment with Xeloda. The companies stated that full results will be presented at a future scientific meeting.

Commenting on the news, Cowen & Co. analyst Eric Schmidt remarked that “enthusiasm is somewhat tempered” because the duration of benefit is not known and because it is unclear how long trials of the drug in breast cancer will take. Nexavar is already approved in countries worldwide to treat kidney and liver cancers.

Source: FirstWord

Popularity: 5% [?]

Japan’s Ministry of Health, Labour and Welfare approved Bayer’s Nexavar (sorafenib) for the treatment of unresectable hepatocellular carcinoma, Bayer announced Wednesday.

Nexavar is currently the only drug shown to significantly improve overall survival in patients with the disease, according to the drugmaker. The product, which was jointly developed by Bayer and Onyx, is already marketed in Japan to treat advanced kidney cancer.

Source: FirstWord

Popularity: 3% [?]

Bayer announced Tuesday that it will collaborate with Ardea Biosciences to develop and market small molecule mitogen-activated ERK kinase (MEK) inhibitors for the treatment of solid tumours, in a deal worth up to $407 million for Ardea. The global agreement includes the US biotechnology company’s lead compound RDEA119, currently in Phase I and Phase I/II studies for different tumour types.

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Under the terms of the deal, Bayer will make an initial cash payment of $35 million to Ardea, which will in turn be responsible for the completion of the two studies which are currently in progress for RDEA119. Bayer will then undertake further development and commercialisation of RDEA119 and any other MEK inhibitors developed by Ardea, and will acquire an exclusive worldwide licence to develop and market the company’s MEK inhibitors for all indications. The potential value of $407 million includes the upfront payment, as well as development, regulatory and sales milestones that Ardea is eligible to receive. In addition, Ardea could receive “low double-digit” royalties on sales of products that reach market.

RDEA119, an MEK inhibitor for the treatment of cancer and inflammatory diseases, is being tested as a single agent in the Phase I trial, and in combination with Bayer and Onyx’s Nexavar (sorafenib) in the Phase I/II study.

Source: FirstWord

Popularity: 4% [?]

Bayer and Onyx announced Monday that a late-stage trial investigating Nexavar (sorafenib) as a potential treatment for patients with advanced melanoma was halted early. The drugmakers said the decision was based on results from an interim analysis by an independent data monitoring committee, which determined the study would not meet its primary endpoint of improved overall survival among patients taking the drug in combination with chemotherapy, versus those receiving chemotherapy alone.

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Results from the randomised trial, which involved patients with unresectable stage III or stage IV melanoma, showed that “the treatment effect was comparable in each arm,” the companies said. Bayer and Onyx will “further review the findings of this analysis,” which are expected to be presented at an upcoming scientific conference, “to determine what, if any, impact these data might have on other ongoing Nexavar melanoma trials.”

Dimitris Voliotis, vice-president of global clinical oncology at Bayer, stated that the companies “remain committed to our broad clinical programme to investigate the potential of Nexavar in a wide range of cancers, and we intend to build upon the success of Nexavar in our approved indications.” The drug is currently cleared for use as a treatment for liver cancer and advanced kidney cancer.

Commenting on the development, DZ Bank analyst Peter Spengler noted that “melanoma is a tough venture to tackle. It is worth trying since there is a high medical need, but with low rates of probability for success.” A company spokesperson said the news will not alter Bayer’s previous outlook for Nexavar of more than 2 billion euros ($2.6 billion) in eventual peak annual sales, saying the forecast did not include projections for the melanoma indication.

Source: FirstWord

Popularity: 3% [?]

Bayer announced Tuesday that the company entered a new strategic agreement with Genzyme under which Bayer agreed to transfer its haematological oncology portfolio to Genzyme. The deal includes leukaemia treatment Campath (alemtuzumab), anti-infective drug Leukine (sargramostim) and chemotherapy product Fludara (fludarabine).

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According to the terms of the alliance, Bayer will transfer to Genzyme global development and distribution rights for Campath for the treatment of B-cell chronic lymphocytic leukaemia, and give Genzyme exclusive worldwide licenses for Leukine and Fludara for all present and future indications. In return, Bayer will receive as much as $650 million from Genzyme in milestone and royalty payments.

In addition, Bayer will return to Genzyme the worldwide rights to Campath, but the companies will continue an established partnership to co-develop the drug as a potential treatment for multiple sclerosis. Should the drug eventually be approved for the MS indication, Bayer said that it “has the option and will exercise its right” to co-promote the treatment globally for that use, and would be eligible to receive up to $1.25 billion in royalties from Genzyme over a 10-year period.

Bayer Chairman Arthur Higgins commented that the deal, which is expected to close in the second quarter, “assures that [the companies] are better aligned to maximise the opportunity for alemtuzumab in both oncology and multiple sclerosis, and frees up resources to accelerate the development” of Bayer’s oncology pipeline. The deal is expected to enable Bayer to focus its resources in oncology on Nexavar (sorafenib) and “additional product developments.”

Bayer estimated that approximately 330 positions globally at Bayer will be affected by the agreement, including around 250 in the US. The two companies “will work together on a process to identify opportunities for continued employment for individuals in these positions as the business and manufacturing operations transition into Genzyme,” Bayer stated.

Source: FirstWord

Popularity: 4% [?]

Novartis announced Monday that the FDA approved its mTOR inhibitor Afinitor (everolimus) for patients with advanced renal cell carcinoma whose disease has progressed after treatment with other cancer therapies. Joe Jimenez, CEO of Novartis Pharma, remarked that “Afinitor is a drug that really has the potential to treat many different cancers…This will be a substantial drug for Novartis.”

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The company said the approval was based on late-stage RECORD-1 data showing that Afinitor more than doubled the time without tumour growth or death in patients with advanced kidney cancer, and reduced the risk of disease progression or death by 67 percent, compared to placebo. The FDA specified that the drug is intended for patients who have already tried Pfizer’s Sutent (sunitinib) or Bayer’s and Onyx’s Nexavar (sorafenib).

Jimenez added that Novartis believes Afinitor “has the potential to be a blockbuster and that’s before we even get to breast cancer, gastric cancer and non-small-cell lung cancer.” The compound has been submitted to regulators in the EU, Switzerland and Japan, as well as in other countries.

Source: FirstWord

Popularity: 6% [?]

The National Institute for Health and Clinical Excellence issued final guidance Wednesday recommending Pfizer’s Sutent (sunitinib) as a first-line treatment for patients with advanced and/or metastatic renal cell carcinoma who are suitable for immunotherapy. Pfizer had previously reached an agreement with NICE, under which the drugmaker would pay for the first six-week cycle of treatment for patients taking Sutent.

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The final guidance reverses an earlier recommendation by NICE not to approve Pfizer’s drug, along with Roche’s Avastin (bevacizumab), Bayer’s and Onyx’s Nexavar (sorafenib) and Wyeth’s Torisel (temsirolimus), for use on the National Health System to treat advanced and/or metastatic kidney cancer. The agency explained that its appraisal of Sutent was separated from the appraisal of Avastin, Nexavar and Torisel “in order to get guidance out to the NHS as quickly as possible.”

Source: FirstWord

Popularity: 6% [?]