head and neck cancer

Introgen gets positive Phase III Advexin data

Tue, 15 Apr 2008 06:59:56 -0400

Introgen Therapeutics announced that a preliminary analysis of a late-stage trial of Advexin confirmed their mid-stage efficacy data for patients with recurrent head and neck cancer. And researchers added that a biomarker for the gene target is predictive for identifying patients likely to respond to the therapy. Austin-based Introgen says it will file for approval in U.S. and Europe this quarter.

"Advexin provides therapeutic benefit by restoring p53 tumor suppressor function which is blocked in the majority of head and neck cancers," said Robert E. Sobol, senior vice president, medical and scientific affairs.

- check out the release
- read the report from BioWorld

Related Articles:
Introgen reports biomarker link to new therapy. Introgen report
Introgen touts cancer data. Introgen report

ALSO NOTED: Meda buys late-stage drugs;Debiopharm licenses peptide;and much more...

Mon, 14 Apr 2008 06:59:50 -0400

> How might drugmakers navigate the rocky waters of generic competition, cautious regulators, safety scandals, globalization, and so on? Seek help with the itinerary from an expert, perhaps. At least six top U.S. drugmakers have done this, putting strategy gurus in top offices. Report

> Meda has paid $20 million for the exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA. Release

> Analytical NanoTechnologies has inked an agreement to acquire the entire issued share capital of Microarray for £1 million. Report

> Debiopharm Group has inked an option and license agreement with Airmid to develop an ShK peptide called Debio 0824, a potassium channel blocker currently in early preclinical development for autoimmune diseases. Release

> Introgen Therapeutics says that ADVEXIN Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of ADVEXIN efficacy. Release

> Alfacell announced that Dr. Intae Lee with the University of Pennsylvania has reported that Alfacell's Onconase (ranpirnase) could be a promising radiation sensitizer for lung cancer treatment. Release

> Nuvelo announced preclinical data demonstrating the mechanism of action and the potent therapeutic activity of NU206 (R-spondin1) in chemotherapy or radiation-induced oral mucositis models. Release

> Misleading minutes, swearing execs--just another day at the office for Vytorin's critics. Report

> If you had any doubt why Pfizer, GlaxoSmithKline, and other Big Pharma companies are drooling over business in the developing world, take a look at a new Deutsche Bank report on the Indian drug market. Report

And Finally… Co-pays on some expensive biotech drugs can now climb as high as 33 percent. Article

Genzyme to collaborate on gene therapy in China

Fri, 26 Oct 2007 06:59:57 -0400

Readers of FierceBiotech are no strangers to all types of licensing deals, but Genzyme's new collaboration with a Chinese company may stand out. Genzyme is partnering with Shanghai-based Sunway Biotech to develop the experimental gene therapy Ad2/HIF-1a in China. Currently undergoing mid-stage trials in Europe and the U.S., Sunway will produce the gene therapy at its Shanghai plant and undertake clinical trials in China. Sunway is notable for being one of two companies which have bragging rights to commercializing a gene therapy. Its gene therapy for head and neck cancer was approved in China in 2005. Genzyme's gene therapy candidate is being tested to determine if it can successfully spur the development of new blood vessels in treating patients with peripheral arterial disease. Sunway--which has been actively seeking out Western development partners--will take the therapy through early and mid-stage tests and both companies will fund a late-stage study.

"We are eager to begin working with Genzyme, one of the established leaders in the field of gene therapy," says Sunway CEO Hu Fang, M.D. "This collaboration allows us to expand our focus beyond oncology to include cardiovascular disease, another area of serious unmet medical need where innovative therapies are urgently needed."

- check out the release for more information

Introgen reports biomarker link to new therapy

Thu, 27 Sep 2007 06:59:55 -0400

Introgen Therapeutics says that their researchers have found a statistically significant link between an abnormal p53 biomarker and response to their experimental therapy for head and neck cancer. The researchers plan to use that knowledge in analyzing data from a late-stage trial of Advexin. The company had already amended its INDA to include an analysis of the response to the drug by patients with the abnormal p53 biomarker. According to Introgen: "Tumor response after Advexin monotherapy was observed in 35 percent of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group. The majority of these patients had recurrent disease after receiving standard therapies."

- see the release on the data

Related Articles:
Introgen touts cancer data. Report
Reactivated p53 gene plays role in fighting tumors. Report

ALSO NOTED: Vernalis reports "striking" weight loss in trial; Genmab shares surge on Phase III; FDA wants more time on Entereg;

Thu, 13 Sep 2007 06:59:50 -0400

> Vernalis is reporting "striking" weight loss results in its Phase I trial of the obesity drug V24343. Release

> Shares of Genmab surged today after the company reported that it's pushing HuMax-EGFr (zalutumumab) into Phase III for head and neck cancer. Report

> Adolor says that the FDA wants more time to review submissions before it decides on whether it will lift a clinical hold on Entereg for postoperative ileus. Report

> A new study of the breast cancer drug tamoxifen demonstrates that it not only works against bipolar disease, it also works faster than many standard therapies. Report

> Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America announced that the first patient has been enrolled in a Phase III study of lubiprostone for opioid-induced bowel dysfunction. Release

> Anesiva has initiated a new Phase II study of Adlea for the relief of post-operative pain in patients undergoing total knee replacement surgery. Release

> Trasylol got something of a reprieve yesterday when an FDA advisory panel recommended that it stay on the market. Report

> When does good news feel almost bad? When a blockbuster drug is deemed the juiciest on the market--but the wolves are circling. If this sounds like Lipitor to you, you're right. Report

And Finally… A U.S. biotech company, Yorktown Technologies, is seeking regulatory permission to import and sell fish that have been genetically modified to glow. Researchers have been developing the fish to identify contaminated waters--though it looks like there could be quite a market among exotic fish lovers. Report

Abigail Alliance v. Von Eschenbach: A closer look

Fri, 10 Aug 2007 06:59:59 -0400

Abigail Alliance v. Von Eschenbach: A closer look

In 2003, the Abigail Alliance for Better Access to Developmental Drugs sued the FDA to gain greater access to unapproved drugs. The Alliance was founded by Frank Burroughs, the father of Abigail Burroughs, a young woman who was diagnosed with squamous cell carcinoma of the head and neck. After conventional therapies failed, she campaigned hard for access to experimental drugs. However, she did not meet entry criteria for clinical trials of two (then) unapproved cancer therapies--ImClone's Erbitux and AstraZeneca's Iressa. Abigail eventually died while waiting for newer treatment. Erbitux was later approved for head and neck cancer and Iressa for lung cancer.

Currently, the FDA allows limited "compassionate use" of experimental therapies. Patients who don't meet study entry criteria but have no other treatment options may be eligible receive unapproved drugs that have completed Phase II or III trials. But the Abigail Alliance wants patients to have access to therapies after Phase I trials are completed. In its suit, the Alliance argued that after a drug passes Phase I, they are sufficiently safe for expanded human use and should be available to terminally ill patients.

To dying patients, unapproved drugs must look like a treasure trove of possible cures and one can certainly understand their willingness to try any new therapy. But by their very nature, Phase I trials are small and are designed to expose as few people as possible to untested therapeutics to minimize risks. We often see promising drugs go up in flames because of toxicity or efficacy concerns, and early-stage drugs (especially cancer therapies), which haven't survived the rigors of later testing, are more likely to be ineffective and even deadly. Only one in five drug candidates that enter clinical trials will receive FDA approval; most will be abandon because of safety or efficacy problems. Without Phase II and III clinical trials, there is a very real risk that a drug will do more harm than good.

But the Alliance argued that dying patients have a constitutional right to self-defense, which extends to choosing what risks they're willing to face to extend their lives. Should a terminal patient have the right to take a drug that may worsen their condition or even speed up their death? The court ruled that the constitutional right to self-defense doesn't include assuming any and all risk. "Recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process," ruled the majority in the decision.

Aside from safety and efficacy, there are a number of other reasons why expanded access is problematic:

Investigational drugs are extremely expensive to produce and supplies are generally limited.
Finding a physician willing to administer an inadequately tested drug would be difficult at best given the potential liabilities.
Expanded access would erode the FDA's authority. There would be loss of control over the actual access to prescription drugs, and untested therapies could be provided to patients outside of clinical trials which the FDA has not approved.
Perhaps most importantly, if patients can get new drugs before clinical trials are completed, it would seriously undermine the entire clinical trial process because patients would have no reason to enroll in trials. If the drug is available outside of a clinical trial, the rigorous scientific controls over the data normally collected during the conduct of a study would be lost. This would slow the approval process to the detriment of the general public.

The FDA is under pressure from critics who say it allows unsafe drugs on the market. But patient advocates castigate the agency for taking too long to get new therapies to the public. Both arguments are valid, and it's essential that the FDA find the delicate balance between the two. The Abigail Alliance plans to appeal the case to the Supreme Court. - Maureen Martino

ALSO NOTED: Vasogen gets direction on Celacade: EndoCeutics pulls IPO; Ventana cool to bid; and much more...

Wed, 27 Jun 2007 00:01:30 -0400

> U.S. regulators have strongly suggested that Vasogen undertake a study to confirm the clinical data on Celacade before filing for approval of the heart medication. Report

> EndoCeutics has pulled its IPO, citing market conditions and a changeup in its schedule for clinical trials. The Canadian biotech is developing hormone therapies for breast cancer and endocrine-related disorders. Report

> Ventana Medical Systems has taken a cool attitude toward Roche's $3 billion takeover bid. Investors, though, showed more enthusiasm, bidding up Ventana stock 48 percent on the news from yesterday. Report

> ViroPharma's hepatitis C therapy has been fast-tracked by the FDA. Report

> Sanofi's Taxotere has been granted a priority review by the FDA for head and neck cancer. Report

> CytRx announced promising data from the six-month, open-label extension of its completed Phase IIa clinical trial with arimoclomol in ALS volunteers. Release

> As states begin to track pharma gifts to doctors, psychiatrists are increasingly coming up as top beneficiaries for pharma payments. Report

And Finally... Scientists have developed a new method using nanoparticles to deliver drugs. Report

CEL-SCI blueprints new manufacturing plant

Mon, 22 Jan 2007 19:01:34 -0500

BioProperties has committed $15 million to CEL-SCI to build a manufacturing plant for its cancer drug Multikine. The therapy is approved for a Phase III trial for head and neck cancer. The facility will cost up to $14 million, which CEL-SCI will pay for through a long-term lease.

"We will be able to produce our drug Multikine in our own CGMP facility for Phase III trials as well as for sale once marketing approval is granted," says Geert Kersten, CEO of CEL-SCI. "An additional benefit of having this facility," Kersten adds, "is that during the Phase III study, it may also be used for contract manufacturing work with other biotech companies and/or the U.S. government since it will contain a clean cold-fill suite."

- see the release on the deal

FDA approves Taxotere for head, neck cancer

Tue, 17 Oct 2006 20:01:36 -0400

The FDA has approved Sanofi-Aventis' Taxotere as a combinational therapy for advanced, inoperable head and neck cancer. The approval was based on a Phase III trial that saw the average length of progression-free survival jump to 11.4 months from 8.3 months. "With this approval, I hope to see TPF become the standard of care for induction therapy for patients with this type of cancer," said Marshall Posner, medical director of the head and neck oncology program at Dana-Farber Cancer Institute. Taxotere is already in wide use for a variety of cancers.

- check out the UPI report on the approval

Related Article:
Sanofi-Aventis' revealed positive Taxotere results ASCO. Report

Cytokinetics' ispinesip flunks another trial

Mon, 02 Oct 2006 20:01:34 -0400

Cytokinetics has announced that a Phase II trial of ispinesib for head and neck cancer failed to hits its primary endpoint. The best overall response trial was disease stabilization, which was observed in 5 of the 19 patients. In a press release, the company said the results didn't justify moving ispinesip on to further trials. Back in March Cytokinetics determined that inpinesib didn't demonstrate sufficient anti-tumor activity to justify moving on to the next step in a mid-stage study. Cytokinetics is developing the drug with GlaxoSmithKline.

- see the company press release

YM BioSciences gains $14.5M up front in licensing deal

Sun, 30 Jul 2006 20:01:37 -0400

A subsidiary of Canada's YM BioSciences has licensed the Japanese development and marketing rights to its anti-EGFR humanized antibody, nimotuzumab, to Daiichi Pharmaceutical. Daiichi has agreed to pay $14.5 million up front and "significant milestone payments." Nimotuzumab was recently approved in India for head and neck cancer and is in Phase III in Europe in combination with radiation for the treatment of pediatric pontine glioma. "The license will result in a substantial broadening of the development and commercialization efforts directed to our anti-cancer antibody," said David Allan, chairman & CEO of YM BioSciences.

- check out the release on the deal

Sanofi inks $360M in cancer pact

Tue, 04 Jul 2006 20:01:39 -0400

Sanofi-Aventis has agreed to pay up to $360 million in up front and milestone payments for most of the global rights to Taiho's S-1 cancer therapy. S-1 is already approved for marketing in Japan for a variety of conditions that includes colorectal, head and neck cancer and is in Phase III for Europe and the United States. Sanofi will also pay royalties on any future sales.

- here's the report on the deal from Trading Markets

PLUS: Sanofi-Aventis' vaccine unit has been warned about problems at a Pennsylvania plant. Report

Erbitux approved for head and neck cancers

Wed, 01 Mar 2006 19:01:36 -0500

The FDA has approved ImClone's Erbitux for head and neck cancer, the first new therapy for those indications in almost half a century. "This is the first drug approved for head and neck cancer that has shown a survival benefit in this population," the FDA said. The approval came for head and neck cancer that couldn't be removed by surgery. Merck, which markets the therapy in Europe, said last week that a European drug committee issued a favorable opinion of Erbitux for head and neck cancer. Erbitux was originally approved for colorectal cancer.

- read this report from TheStreet.com for more information

ImClone touts increased survival rate in Erbitux cancer trial

Tue, 15 Nov 2005 19:01:36 -0500

ImClone Systems is touting results of a late-stage trial that shows patients with head and neck cancer lived an average of 19.7 months longer while taking Erbitux rather than radiation alone. Median survival for radiation-only patients was 29.3 months. ImClone has applied for expanded use of Erbitux for head and neck cancer.

- read this press release for more information

SPOTLIGHT: ImClone pushes new indication

Sun, 19 Jun 2005 20:01:33 -0400

Following the successful conclusion of trials into Erbitux for head and neck cancer, ImClone says it will seek expanded use of the cancer drug in the third quarter. Erbitux is currently indicated for colorectal cancer. Story

Erbitux effective in cancer trial

Tue, 07 Jun 2005 20:01:39 -0400

Imclone announced that a late-stage trial shows that Erbitux combined with radiation therapy can prevent the spread of head and neck cancer. The drug proved statistically significant in both survival and progression-free survival among patients with head and neck cancer. The drug has already been approved for colorectal cancer.

"Head and neck cancer remains a disease with too few treatment options and no new therapeutic product approvals in over a decade," said Eric K. Rowinsky, chief medical officer of ImClone. "We look forward to discussing the next steps toward a regulatory filing with the FDA."

- read this story from the AP for more

ALSO: Wall Street financier Carl Icahn has indicated his intention to increase his stake in Imclone. He currently owns 6 percent of the company's stock.