colon cancer

A deluge of pre-ASCO data hits the market

Fri, 16 May 2008 06:59:57 -0400

As we mentioned earlier this week, data from almost 5,000 clinical studies was released last night in preparation for next week's ASCO meeting. And some of the most interesting data won't be released until the conference. In the meantime, here's a sampling of the trial results that are making waves today.

Kidney cancer patients taking Novartis' RAD001 (everolimus) had progression of their disease delayed by a year, a significantly better result than in those taking placebo. Release
Amgen's brain tumor drug AMG-102 may only work on a subset of patients. The data is from a small Phase II study of the drug. On a better note, Amgen said denosumab cut the risk of bone fractures in cancer patients, outperforming Novartis' Zometa in an early stage trial. Release
A Phase III trial of Avastin for early-stage colon cancer will be available sooner than previously thought, said Genentech, because of faster data collection and more patients with the disease. Data will be available in 2008--a full year earlier than previously planned. Release
BioVex said data from a Phase II trial of OncoVEX demonstrated an impressive rate and durability of response in patients with advanced metastatic melanoma. Release
Nektar Therapeutics announced results form a Phase I study of NKTR-102. The data shows significant anti-tumor activity in patients with refractory solid tumors. Release

ALSO NOTED: Curis earns $3M milestone; Lethal viral outbreak in China; and much more...

Mon, 05 May 2008 06:59:50 -0400

> Roxro Pharma announced it has received an Excellence and Innovation Award from the Committee on Scientific Papers of the Society for Ambulatory Anesthesia for the Phase III data of the company's novel intranasal pain reliever ROX-888. Release

> Genentech has begun a mid-stage study of an experimental therapy for colon cancer, GDC-0449, triggering a $3 million milestone payment for Curis. Curis release

> Minerva Biotechnology says it has used its nanoparticle technology to elucidate a key molecular mechanism that is involved in cancer cell growth and metastasis. Minerva release

> Pfizer is starting to settle the thousands of lawsuits over painkillers Celebrex and Bextra. Pfizer report

> Outsourcing is still on roll--it's just not rolling quite as fast as it did last year, according to Contract Pharma's 2008 outsourcing survey. Outsourcing report

> Pharma needs to slap some raw steak on its black eye, Dr. Roy Vagelos said during a speech last week. Pharma's elder statesman--and ex-Merck CEO--says the drug industry has lost goodwill and credibility, and needs to get to work to repair its reputation. Report

> Should insurers be allowed to reward docs who switch patients to generics? That debate is going public in Colorado, where legislators have proposed a bill that would prohibit the practice. Report

And Finally… An outbreak of the lethal Enterovirus 71, or EV-71, has stricken more than 6,000 people in China and left 26 children dead. There is no vaccine available to contain EV-71, which triggers a severe form of hand, foot and mouth disease, according to the Wall Street Journal. Article

ALSO NOTED: FDA nixes Avastin for breast cancer; P&G reveals Phase II UC data;and much more...

Thu, 06 Dec 2007 06:59:50 -0500

> Avastin got the big thumbs-down from an FDA advisory panel yesterday. The Genentech drug, approved for use against colon and lung cancer, was up for consideration as a breast-cancer therapy, but expert panelists weren't impressed with the data. Report

> Procter & Gamble is touting two Phase III studies of Asacol, an ulcerative colitis treatment. Asacol was effective and well-tolerated treatment for patients with inflammation of the lining of the colon and rectum, including isolated proctitis. Patients with isolated proctitis who took Asacol, experienced significant improvement of UC symptoms as early as three weeks, and sustained improvement at six weeks. Release

> What's the biggest risk of relying on Chinese drug manufacturers? Ask any five people on the street, and you'd likely get "contamination" as your answer five times. But experts are increasingly worried that China's explosive growth in drug and active-ingredient manufacturing presents a national-security risk. Report

> Eli Lilly is prediction a big year in 2008, with 14 percent growth in net profits and seven billion-dollar-plus products. Report

And Finally... It's not fat but fitness that predicts longevity in adults over the age of 60. Report

SPOTLIGHT: Erbitux ok'd as front-line colon cancer drug

Wed, 03 Oct 2007 06:59:53 -0400

The FDA has approved an Erbitux label update to include additional survival data. ImClone and Bristol-Myers Squibb, who make the drug, announced back in January that research indicated Erbitux proved effective as a front-line therapy against colon cancer. Release

SPOTLIGHT: Breast cancer therapies get nod

Fri, 14 Sep 2007 06:59:53 -0400

Breast cancer is making headlines today: Eli Lilly got the FDA's nod to market its osteoporosis drug Evista as a breast cancer preventative, and Genentech got word that the agency will consider its colon-and-lung cancer drug Avastin for breast cancer treatment. FiercePharma

Clinical trial data disappoint Amgen investors

Thu, 25 Jan 2007 19:01:38 -0500

Amgen says that a new trial of its anemia drug Aranesp indicated a higher risk of death among patients with anemia caused by cancer. Aranesp is currently approved to treat anemia caused by chemotherapy and Amgen has been looking to broaden its approval for the drug. The new data raises new questions about the risks posed by Aranesp as well as two similar drugs--Epogen and Procrit--with a combined $10 billion market. Last November a separate study concluded that Procrit increased the risk of death among kidney disease patients by 34 percent.

In the Aranesp trial researchers were exploring whether the therapy could reduce the number of blood transfusions to combat anemia. The trial concluded that the drug did not reduce the number of transfusions but did increase the number of patients in the group by a statistically significant amount. Even though the drug is not approved to treat anemia from cancer, a company official estimated that up to 12 percent of the sales of Aranesp are for the off-label use of the drug for that indication.

In addition, Amgen said a new study of Vectibix as a front line therapy against advanced colon cancer failed to demonstrate any advantage over standard therapy. Vectibix is approved for patients who have failed to respond to chemotherapy. Several analysts said that the pair of disappointing results cast a significant pall over Amgen's ability to grow revenue.

- check out Amgen's press release on the data
- read the article on Aranesp from The New York Times

Related Articles:
FDA wants more data on new Aranesp doses. Report
Aranesp may work for heart failure. Report
Major challenges loom for Amgen. Report
Amgen launches price war on Vectibix OK. Report

Erbitux data backs use as front-line therapy

Tue, 09 Jan 2007 19:01:35 -0500

Researchers announced that Erbitux proved effective as a front-line therapy against colon cancer, a big development for a therapy that is currently approved only after the unsuccessful use of chemotherapy. Data indicates that Erbitux delays progression of the disease when given as a combinational therapy with chemotherapy. That's good news for Bristol-Myers Squibb and ImClone, which share the revenue from the drug. Merck KGaA is ImClone's partner outside of the U.S. All three have been threatened by Amgen's Vectibix, which is putting pressure on the price of the drug.

- see the release on the data
- here's the report on Erbitux from CNN

Related Articles:
Analysts raise doubts on Erbitux ruling. Report
Erbitux effective in cancer trial. Report
Icahn takes control of ImClone as CEO departs. Report

ALSO NOTED: Santarus inks licensing deal; NeurogesX reports positive data; and much more...

Tue, 17 Oct 2006 20:01:30 -0400

> San Diego-based Santarus will gain $15 million up front and up to $65 million in milestones in a licensing deal with Schering-Plough for a low-dose version of the heartburn drug Zegerid. Report

> NeurogesX announced positive results from a Phase III trial of Transacin (NGX-4010), a high-concentration trans-capsaicin dermal patch, in patients with post-herpetic neuralgia. Release

> Auxilium Pharmaceuticals has abandoned development of TestoFilm, a testosterone-replacement transmucosal-film product for the treatment of hypogonadism. Report

> EXACT Sciences, which makes colon cancer detection technology, is laying off 21 of its 44 employees in a bid to conserve cash as it seeks new approvals. Report

And Finally… Every year more than 700,000 Americans end up in hospital ERs after experiencing a drug reaction. Article

FDA approves Avastin for lung cancer

Wed, 11 Oct 2006 20:01:35 -0400

As expected, the FDA has approved Genentech's Avastin as a front line therapy for the most common kind of lung cancer. Some 162,000 Americans die every year from lung cancer. Avastin, already approved for colon cancer, will be provided to qualified patients for a discounted price of $55,000 a year, but only for approved indications. Genentech and other drug developers have been harshly criticized for demanding astronomically high retail prices on new therapies.

- read the AP report on the approval

Gene therapy cures two of advanced melanoma

Thu, 31 Aug 2006 20:01:38 -0400

Scientists at the National Cancer Institute are heralding what they call the first successful gene therapy experiment in cancer after curing two men with advanced melanoma. Genetically altered immune cells wiped out all signs of the cancer in the two men, though they did not help 15 other volunteers in the experiment. This is the first time, they say, that gene therapy for cancer has worked at an advanced stage of the lethal disease. And new gene therapy trials are being planned for advanced breast cancer and colon cancer. Dr. Len Lichtenfeld of the American Cancer Society called it an exciting "proof of concept" that the therapy will work.

- read the AP report on the experiment

Avastin encounters rare failure for pancreatic cancer

Mon, 26 Jun 2006 20:01:38 -0400

Genentech's Avastin has finally run into a clinical obstacle. The biotech company said it is halting research into Avastin as a therapy for pancreatic cancer after determining that the therapy was not extending the lives of patients to any significant degree. Genentech still believes that Avastin has broad applications, noting that the drug is currently in 130 clinical trials covering 25 different types of cancer. Avastin was originally approved for colon cancer.

- here's the report on Avastin from TheStreet.com

SPOTLIGHT: FDA expands Avastin label

Tue, 20 Jun 2006 20:01:33 -0400

The FDA has expanded the label on Genentech's blockbuster cancer drug Avastin to include it as a second line treatment for advanced colon cancer. Report

Researchers renew enrolling cancer trial patients

Mon, 22 May 2006 20:01:36 -0400

Hoffman-LaRoche has renewed enrolling patients in a clinical trial of a combination of Xeloda and Avastin as a therapy for colon cancer. Enrollment had been suspended early this year after the sudden deaths of four patients involved in the study. But researchers say their independent safety review board said mortality rates were similar across all groups. They added a cardiac monitoring plan to detect any other deaths in the study that might occur.

- here's the AP report

Safety concerns halt Avastin trial

Sun, 12 Feb 2006 19:01:39 -0500

Genentech and Roche Holdings, its majority owner, have suspended enrollment in a Phase III trial of Avastin for colon cancer after the deaths of four patients. Three of those four patients were younger people taking Avastin with Xeloda, which particularly troubled researchers. The news immediately hit shares of Roche in early trading. Researchers are exploring the utility of Avastin as an adjuvant therapy for post-surgical colon cancer. The Data Safety Monitoring Board believes that the rapid enrollment of 200 patients a month may have hindered proper safety evaluations.

Genentech said that it was right to temporarily halt enrollment so they could do a thorough analysis of safety data. Avastin is approved for colorectal cancer in patients whose disease has metastasized, an indication that should earn the companies $1.5 billion this year. Analysts doubted that the trial setback would create any significant long-term damage for either company's earnings.

- read this article from the Financial Times

Introgen's INGN 241 with Celebrex could fight breast cancer

Tue, 08 Nov 2005 19:01:35 -0500

A preclinical study conducted by Therapeutics found that the company's drug INGN 241, combined with Celebrex, works to inhibit the growth and increase cell death of breast cancer cells. Celebrex is marketed by Pfizer for the treatment of arthritis and familial adenomatous polyposis, a condition that, if left untreated, can result colon cancer. Researchers hope that the drug combination could provide low-toxicity treatment options for breast cancer patients.

- read the press release for more details

ALSO NOTED: FDA wants more time to review Exubera; Regulators approve new version of Kaletra; Erbitux to get priority review; a

Sun, 30 Oct 2005 19:00:50 -0500

> On Friday the FDA told Pfizer and Sanofi-Aventis that it would need an additional three months to study its inhaled insulin Exubera. An FDA advisory panel recommended approval last month. Report

> The FDA has approved a new version of the HIV drug Kaletra from Abbott Laboratories. Report

> Bristol-Myers Squibb and ImClone Systems have won a priority review for Erbitux as a treatment for head and neck cancer. Erbitux is approved as a therapy for colon cancer. Article

> A late-stage trial of Cimzia shows that a single injection was effective in controlling the signs and symptoms of Crohn's disease. Release

> AstraZeneca's Zactima has won orphan drug status for certain types of thyroid cancer. Report

> Sanofi-Pasteur has licensed a vaccine booster from Eisai. Article

> The FDA has accepted the supplemental BLA from Biogen and Elan for Rituxan for patients with active rheumatoid arthritis who inadequately respond to anti-TNF therapy. Release

> CytoKinetics has lined up $75 million in equity financing. Release

> The FDA has approved GlaxoSmithKline's Arranon for patients with particular types of leukemia and lymphoma. Release

> Invitrogen has struck a research partnership with China's drug screening center. Report

> PharmaFrontiers has received a green light from the FDA for a Phase IIb study of Tovaxin for MS. Release

> Am-Pharma of The Netherlands has lined up new financing. Release

And Finally… Mars is rolling out a new line of chocolate bars that it says are good for your health. Article

VC: Bioheart expands venture round

Wed, 05 Oct 2005 20:01:32 -0400

Bioheart expands venture round

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Bioheart Sunrise, FL	$19 million undisclosed	Advent-Morro Equity Partners	Researchers are focused on a myogenic cell composition made up of adult muscle repair cells called myoblasts to repair damaged heart muscles.
Pervasis Therapeutics Cambridge, MA	$12 million second round	Highland Capital Partners	Researchers are at work integrating biomaterials with cells and drugs.
Newron Pharmaceuticals Milan	€7 million Second round add-on	TVM	Newron is involved in the ongoing phase III clinical development of Safinamide for the treatment of Parkinson's disease and phase II development of Ralfinamide for neuropathic pain.
BioLineRx Jerusalem	$9 million add-on	Giza Venture Capital, Pitango Venture Capital, Teva Pharmaceuticals Industries	BioLineRx plans to move BL-1020 for schizophrenia into human clinical trials in the first quarter of 2006.
Tessera Seattle	$8.5 million second round	undisclosed	Tessera has been developing tests for the early detection of prostate and colon cancer.

ALSO NOTED: FDA to take interim NeoPharm data; Caraco wins tentative drug OK; Aspirin works against colon cancer; and much more

Tue, 23 Aug 2005 20:00:50 -0400

> NeoPharm says that the FDA will accept interim efficacy data for a late-stage trial of its experimental brain cancer treatment. NeoPharm says it expects full enrollment in the trial by the end of the year. Story

> Caraco Pharmaceutical has won tentative FDA approval for a generic version of Sanofi Aventis' Ambien. Report

> Caraco also announced FDA approval for a new strength of clozapine. Release

> Researchers say that the long-term use of aspirin lowers the risk of colon cancer, but only at the risk of gastrointestinal bleeding. Story

> The FDA has approved the use of Solvay's Aceon for patients with stable coronary artery disease. Report

> A federal judge has ruled that a group of generic drug makers did not infringe on Pfizer's patent for Neurontin -- an anti-convulsant -- by making a low-cost knockoff. Article

And Finally… In a report sure to cheer obesity drug developers, residents in 49 states got fatter in recent years, with Alabama's deep-fried culture leading the way. Article