Results tagged “cancer drugs” from Drugs & Medicaments

Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC).

This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin.

There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and de ath of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.

With budget cuts looming at the National Cancer Institute, a publicly funded cancer cooperative has begun to shut down clinical trials and stop some research programs on a variety of cancers. Among the hardest hit areas, according to a report in The Wall Street Journal, will be rare cancers like sarcoma and head and neck cancers.

The cooperative said that it was eliminating 3,000 spots in clinical trials this year and some groups were shuttering entire trials. The groups were asked to explore ways to cut operations due to flat funding from the federal government, which has been tightening the rein on research funds as it tries to ratchet down the federal deficit. The NCI's proposed budget includes a $9 million reduction in funds--which amounts to a .2 percent slice out of its current budget--so more research cuts are anticipated.

- read the article from The Wall Street Journal (sub. req.)

source FierceBiotech 

Adherex Technologies is paying GlaxoSmithKline a million dollars up front and a set of milestones in exchange for the outstanding options on the cancer drug eniluracil. GSK shuttered its development program for the therapy after it failed a Phase III trial in combination with 5-FU. Adherex, though, believes that the reason for the failure was an "unexpected dose- and schedule-dependent drug interaction that resulted in the inhibition of 5-FU's activation into an effective anticancer agent."

"While GSK's initial Phase III trials with the product failed, we now have data to support each element of our hypothesis as to why those trials failed," says William P. Peters, M.D., Ph.D., chairman and CEO of Adherex. "We expect to complete our Phase I dose-escalation trial in North America shortly and intend to begin our Phase II trial in breast cancer promptly thereafter. We also have a Phase I/II trial in hepatocellular cancer ongoing in Asia."

read the full press release 

Boasting its 20th consecutive profitable quarter, biotechnology powerhouse Genentech on Wednesday reported a 75 percent increase in net income for the fourth quarter of 2006, compared with the same period a year ago.

The South San Francisco company's net income for the three-month period that ended Dec. 31 totaled $594 million, or 55 cents a share. That was up from $339 million, or 31 cents a share, for the fourth quarter of 2005.

Aside from stock options or other special expenses unrelated to its ongoing operations, Genentech said it would have earned 61 cents a share, 5 cents more than what most analysts surveyed by Thomson Financial had predicted.

Biotech drug developer Peregrine Pharmaceuticals Inc. said Tuesday that a recently published animal study showed a technology it licenses could be effective in determining what cancer treatment works in a given patient sooner.

An animal study appearing in the Jan. 1 edition of Clinical Cancer Research showed that microbubbles used in mice being treated for pancreatic cancer allowed ultrasound imaging to determine whether cancer therapies designed to choke off the blood supply to tumors were working or not.

The study used the Vascular Targeting Agent technology that Peregrine licenses exclusively from the University of Texas from Southwestern Medical Center, which conducted the study appearing the journal.

Telik Inc. said on Tuesday that its experimental cancer drug failed to improve survival in patients with advanced lung cancer or in patients with ovarian cancer, sending its stock plunging nearly 70 percent.

The biotechnology company said a late-stage, or Phase III, trial of its most advanced drug, Telcyta, did not significantly improve survival in patients with advanced lung cancer who had failed other treatments, which was the main goal of the trial.

The Palo Alto, California-based company said a Phase III trial of patients with resistant ovarian cancer also failed the trial's main goal of demonstrating significant improvement in survival.

LONDON & WALTHAM, Mass.--(BUSINESS WIRE) -- GlaxoSmithKline plc (GSK) and PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS) announced today execution of a definitive agreement providing for GSK to acquire all outstanding shares of PRAECIS’ common stock for a cash purchase price of US $5.00 per share or a total of approximately $54.8 million for the entire equity interest of PRAECIS.

“PRAECIS has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities,” said Allen Oliff, Senior Vice President, Molecular Discovery Research, GSK.

Danish biotechnology company Genmab A/S signed a deal Tuesday worth up to US$2.1 billion (€1.6 billion) with pharmaceutical giant GlaxoSmithKline PLC for the global commercialization of a leukemia treatment.

The agreement for the HuMax-CD20 antibody includes an initial license fee of 582 million kroner (€78 million; US$102 million), Glaxo buying a stake of just over 10 percent in Genmab and milestone payments totaling 9 billion kroner (€1.2 billion; US$1.6 billion).

GlaxoSmithKline will invest 2.03 billion kroner (€272 million) for the 4.47 million Genmab shares.

Analysts said the value of the deal was much higher than expected, and could mean that Genmab will be profitable as early as next year.

By Robert Goldberg, The Washington Times

Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.

NEW BRUNSWICK, New Jersey (Reuters) - Bristol-Myers Squibb <BMY.N> said on Thursday it could seek approval for as many as three new cancer drugs by next year, including treatments for melanoma and cancers of the breast and bladder.

The company said it plans to seek approval next year for breast cancer drug ixabepilone and to seek approvals by late 2007 or 2008 for bladder cancer treatment vinflunine and melanoma drug ipilimumab.

CANBERRA, Australia (UPI) -- An Australian scientist has developed a drug to treat liver cancer and said the medicine could be available within three years.

Immunologist Professor Christopher Parish, of the Australian National University, told the Australian Broadcasting Corp. that clinical trials showed the drug significantly inhibited the growth of a cancer and its spread to other organs.

'For any primary tumor to grown beyond about a millimeter in diameter, in needs to induce new blood vessels to grow into it,' Parish said. 'Our drug inhibits those new blood vessels growing.'

A LIVER cancer trial of a Brisbane biotechnology company's drug turned out positive results which analysts yesterday described as a "cracker".

The results from the second-round trial were also encouraging enough for Toowong-based Progen Industries to proceed with more advanced research and plans to raise funds.

The sharemarket initially seemed ambivalent, which was linked to investors potentially needing time to absorb the results or an attempt to knock down the share price. But by the afternoon a rush pushed shares up 84¢ to $4.99 – still off all-time highs of $13.18 in February 1997.

Axa PPP has re-launched its Premier Plus medical insurance plan to cover any drugs used to treat cancer, regardless of whether they are licensed.

Premier Plus now pays for any cancer drug which a patient’s oncologist may wish to use, regardless of whether they are licensed, for as long as the oncologist wishes to give them.

In addition, the plan provides a health check every two years, up to £1,000 for one hearing aid every two years, up to £150 a year for chiropody and up to £15 for an annual eye test and up to £250 for prescription glasses or contact lenses every two years.

Clients can use any hospital in the UK and they can opt for a no claims discount and/or excesses of £100, £200 or £500 to reduce costs if they wish.

source - Ifaonline 

BASEL (AFX) - Roche Holding AG said that its latest Phase III study of cancer treatment Xeloda with 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival.

Study results showed that the chemotherapy combination XELOX -- consisting of oral Xeloda plus oxaliplatin -- was as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).

The data will be used in worldwide submissions of the drug.

How much is one month of life worth?

It's a question that has split governments, bankrupted patients and left hospitals with an agonizing moral dilemma.

Health Canada has approved drugs that prolong the life of cancer patients.

They're expensive. They're not a cure. And usually they only give the patient months more to live.

Patients think they're worth every penny.

Governments can't agree. Some provinces pay. Others say they're not worth the small benefit to a few.

VIAGRA and other impotence drugs help switch on the immune system to attack a range of cancers, a study has found.

The disease usually manages to avoid destruction partly because tumours produce a fog of chemicals that hide it from white blood cells.

But Viagra, a brand name for sildenafil, and other such drugs were found to reduce the amount of these chemicals, enabling the immune system to target the cancer more effectively.

Tests at the Johns Hopkins Kimmel Cancer Centre in the United States found the drug reduced the size of colon and breast tumours in mice threefold.

Dec. 6, 2006 -- When first introduced in 2001, Gleevec was hailed as a miracle drug poised to usher in a new age in cancer treatment. Now, five years later, it appears that promise is being fulfilled.

The longest follow-up yet of chronic myeloid leukemia (CML) patients treated with Gleevec shows a survival rate of 95% after five years. (The survival rate does not count people who died from causes unrelated to CML or stem-cell transplantation). Before the drug’s introduction, about half of patients died within five years of diagnosis.

And there is more good news. Relapse rates seem to be trending down the longer patients stay on the drug. After three years of treatment, 15% of patients in the study experienced relapses. Two years later, that figure had risen by just 2%.

Gleevec was the first treatment to specifically target cancer cells, leaving healthy cells unharmed. It is marketed by Swiss drug maker Novartis. 

MUMBAI, Dec 7 (Reuters) - Indian drug maker Dabur Pharma Ltd. (DABR.BO) has received approval from the U.S. Food and Drug Administration for oncology drug paclitaxel injections, the regulatory agency's Web site showed.

Paclitaxel is the generic equivalent of Bristol-Myers Squibb Co.'s (BMY.N) Taxol, used in treating ovarian and breast cancer.

 © Reuters 2006.

LONDON, Dec 1 (Reuters) - GlaxoSmithKline Plc (GSK.L) said on Friday it had won European regulatory approval to sell its Hycamtin medicine as a treatment for cervical cancer in combination with another cancer drug, cisplatin.

The decision was expected after European regulators signalled last month that they intended to approve the new combination treatment.

U.S. regulators approved the combination drug in June.

© Reuters 2006

Nov 27 (Reuters) - Cytokinetics Inc. (CYTK.O: Quote, Profile, Research) said it will be responsible for the costs and activities of further development of two cancer drug candidates following an amendment of a collaboration agreement with GlaxoSmithKline plc (GSK.N: Quote, Profile, Research).

The company also lowered its 2006 revenue outlook to $3 million to $4 million, with research and development expense of $52 million to $56 million. Analysts on average were expecting the company to report revenue of $3.8 million, according to Reuters Estimates. (Reporting by Hari Kumar in Bangalore)

© Reuters 2006.