Recently in Cancer Drugs Category

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.

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.