Cancer Drugs: December 2006 Archives

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.

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.'

GAITHERSBURG, Md.--(BUSINESS WIRE)--GenVec, Inc. (Nasdaq: GNVC) announced today that an independent data safety monitoring board (DSMB) has completed a planned interim analysis of safety data from the ongoing Phase II/III clinical trial with TNFerade™ in locally advanced pancreatic cancer. In addition to its recommendation that the trial continue, the DSMB supported the use of endoscopic ultrasonography (EUS) as an alternative to percutaneous tumor administration. GenVec has provided its interim safety data to the U.S. Food and Drug Administration (FDA) and is waiting for final clearance to move forward with EUS administration.

The Phase II/III clinical trial, known as PACT, is a multi-center, randomized and controlled study of 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care, versus standard of care alone (SOC) in patients with locally advanced pancreatic cancer. This interim evaluation was based on data from 40 patients, 25 of whom received standard of care plus TNFerade.

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.

BASEL (AFX) - Roche Holding AG said an interim analysis of a Phase III study of Avastin in advanced renal cell cancer has shown that the drug significantly prolongs progression-free survival.

Due to the benefits observed, the independent Drug Safety Monitoring Board has recommended that the study be unblinded and all patients will be offered treatment with Avastin.

In addition, this early analysis indicated a trend towards an improvement in overall survival.

Renal cell cancer is the most common form of kidney cancer accounting for nine out of ten cases and treatment options are limited.

Safety was in line with what has been observed for Avastin in previous studies.

source - AFX 

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 (AFX) - ValiRx PLC said it is investing 193,000 stg in emerging US biotechnology company Morphogenesis Inc in addition to subscribing for 250,000 share warrants, exercisable at 1 usd within the next three years.

The cancer therapeutics company said its investment is funding Morphogenesis' ImmuneFx, a cancer vaccine that targets tumours in both humans and pets and said it is due to go into phase II pre-clinical trials in 2007.

The company said it now holds 1.806 mln shares and 250,000 warrants in Morphogenesis.

source - AFX 

LEVERKUSEN, Germany (AFX) - Bayer (nyse: BAY ) AG and Onyx Pharmaceuticals Inc said Phase III skin cancer tests of their Nexavar (sorafenib) tablets failed to meet their primary endpoint of improving progression-free survival (PFS).

'We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for whom treatment options are so limited,' Onyx chief executive Hollings Renton said in a statement.

'However, this trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumours and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity.'

source - AFX 

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