Melanoma

Melanoma therapy produces positive mid-stage data

Tue, 20 May 2008 06:59:54 -0400

Researchers for GlaxoSmithKline and Synta Pharmaceuticals say a mid-stage study of elesclomol produced "statistically significant" data on progression-free survival of patients with metastatic melanoma.

"These data, combined with earlier clinical and pre-clinical data we have presented for elesclomol, support our belief that oxidative stress induction is a promising new approach to cancer therapy in melanoma and, potentially, other cancer types," said Eric Jacobson, M.D., Synta's CMO.

- here's the press release
- read the AFX report

Medarex shares slide on news of drug app delay

Mon, 28 Apr 2008 06:59:55 -0400

Shares of Medarex slipped seven percent this morning as investors digested Friday's announcement that its application for a new cancer drug will be delayed into 2009. The developer says that the FDA wants more data on ipilimumab, which is in late-stage trials. Bristol-Myers Squibb is partnered on the therapy, which is being investigated as a new treatment for metastatic melanoma. The agency is looking for more data on overall survival rates. That left the analysts scrambling to calculate the revenue the company will lose as a result of the delay. Medarex shares have lost more than half of their value since last summer.

- see Medarex's release
- read the AP report

ALSO NOTED: US Oncology's CFO retires; Profits rise at Novartis, Merck, Lilly; and much more...

Mon, 21 Apr 2008 06:59:50 -0400

> US Oncology's CFO Rick McCook is resigning to explore opportunities in a retail or manufacturing business. Release

> Good financial results from three Pharma biggies should cheer up those market-watchers who moaned their way through much of last week. Sure, a couple of the profit leaps came at least in part from one-time gains. But increases are always better than the alternative. Report

> Seeking Alpha profiles Synta's metastatic melanoma therapy Elesclomol. Report

> Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story. Report

> A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its generic version of a Roche drug for an unapproved use. Report

And Finally... Higher food prices and grain shortages are changing attitudes toward biotech crops. Report

Pfizer halts Phase III cancer trial on poor results

Wed, 02 Apr 2008 07:59:58 -0400

Pfizer's big push into cancer drugs has hit a snag. The company announced that it is halting a late-stage trial of tremelimumab for advanced melanoma after researchers concluded it was no more effective than standard chemotherapy. More data from the clinical development of the drug will be revealed at the annual ASCO meeting in June. The move to shutter the trial follows Pfizer's decision to beef up its R&D spend on cancer therapies from 12 percent of its budget to 20 percent. And Pfizer has every intention of staying focused on the field as well as tremelimumab.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high-risk area of research with significant unmet medical need," said Dr. Charles Baum of Pfizer Global Research and Development. "We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer."

- see Pfizer's release
- read the report in the Wall Street Journal

ALSO: The news from Pfizer stung at Medarex after analysts concluded that a failure for tremelimumab also spelled trouble for another partnership it has with BMS to develop ipilimumab. Its stock dropped 14 percent. Report

Related Articles:
Pfizer seeks salvation in late-stage biotherapeutics. Report
Is Pfizer's CEO as bold as promised? Report
A look inside Pfizer's biotech center. Report
Pfizer hires new R&D chief, launches biotech center. Report
Speculation soars over Pfizer's interest in biotech. Report

Morphotek licenses anti-cancer antibody

Thu, 06 Mar 2008 06:59:57 -0500

Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead therapeutic MAb and high-titer cell lines suitable for scalable manufacturing. Morphotek, which was acquired by Eisai last year, has a pipeline of antibodies in development for cancer, rheumatoid arthritis, and infectious disease. Financial terms of the deal were not disclosed.

"This agreement provides yet another important addition to our therapeutic antibody portfolio," said Nicholas Nicolaides, Ph.D., Morphotek's president and CEO. "Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer."

- check out the release

Related Articles:
Eisai acquires Morphotek in $325M deal. Report
Morphotek gains $40M in fourth venture round. Report

Adherex's melanoma drug earns orphan status

Fri, 22 Feb 2008 06:59:55 -0500

North Carolina-based Adherex Technologies has won orphan drug designation from the FDA for its experimental melanoma therapy ADH-1. The drug is currently in Phase IIb trials in combination with regional melphalan. Adherex is also conducting Phase I trials of ADH-1 in combination with Taxotere and Xeloda.

"Our experience to date combining ADH-1 and melphalan for the treatment of in-transit melanoma has been very encouraging," said Adherex CEO Dr. William Peters in a statement. "To continue with the rapid development of this combination, two additional centers, Lehigh Valley and H. Lee Moffitt, have joined our Phase IIb trial which is ongoing at Duke and the MD Anderson."

- here's the release for more

Related Article:
Adherex takes full control of failed cancer drug. Report

Antigenics' cancer vax gets mixed Phase III results

Wed, 20 Feb 2008 06:59:54 -0500

Antigenics' cancer vaccine Oncophage failed to meet its primary endpoint of overall survival in a late-stage clinical trial for metastatic melanoma, but patients receiving a minimum of 10 injections did see an improved median survival of 3.7 months. The results of the Phase III study were previously announced at the American Society of Clinical Onocology in June 2006 and showed that patients with less advanced disease who received at least 10 doses of Oncophage had improved median survival of approximately 18.4 months versus patients who received physician's choice of treatment.

"Patients with stage IV melanoma are particularly difficult to treat. These patients generally have a very poor prognosis and there is currently no consensus regarding standard of care," said Alessandro Testori, MD, Istituto Europeo di Oncologia, Milan, Italy. "The results demonstrate that Oncophage may provide certain melanoma patients additional survival time. Given that currently approved therapies for metastatic melanoma are extremely limited, further investigation is warranted evaluating a predetermined number of Oncophage doses in patients with less advanced metastatic disease."

- read the release

Related Articles:
Antigenics reports positive data in brain cancer trial. Report
Antigenics shares punished on Oncophage failure. Report
Antigenics slashes staff in bid to conserve cash. Report
Big Pharma takes an interest in cancer vaccines. Report

IDM outlines big layoff in restructuring plan

Wed, 16 Jan 2008 06:59:57 -0500

Two weeks after it was jilted in a key drug collaboration deal, IDM Pharma filed papers with the SEC saying it will lay off 60 percent of its workers at core facilities in Paris and Irvine, CA. IDM--which is based in Irvine--had already announced plans to restructure as it shelved a development program for the melanoma drug Uvidem and ratcheted back on its work regarding L-MTP-PE for osteosarcoma. The restructuring should be done earlier this year.

There's still no exact figure, though, on how many IDM workers will get a pink slip. IDM announced at the end of December that Sanofi-Aventis had decided to pull out of a partnership on Uvidem, leaving all rights for the drug with IDM.

- check out the AFX report for more info
- see this release for more

Related Articles:
IDM shares plunge on FDA's rejection. Report
IDM Pharma gets new CEO as founder departs. Report

AstraZeneca drops cancer program after Phase II failure

Thu, 20 Dec 2007 06:59:56 -0500

AstraZeneca says it won't take the advanced melanoma drug AZD6244--licensed from Array BioPharma--into late stage trials after seeing the program flunk Phase II. Researchers said they could see no difference between AZD6244 and Temodar (temozolomide), which is in use to treat brain tumors. That wasn't what investors in Array wanted to hear. They shaved 18 percent off the value of its stock, which had already gradually slid 16 percent this year. AstraZeneca licensed the program four years ago.

- see this release
- read the AP report for more on the results

ALSO: Take a look at AstraZeneca's pipeline. Report

Related Articles:
Analyst: AZ "worst performer" in pharma. Report
Array partners with Celgene, nets $40M upfront. Report
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Medarex shares dive after a cancer trial failure

Tue, 11 Dec 2007 06:59:56 -0500

Shares of Medarex took a dive in after-hours trading after the biotech announced that the cancer drug ipilimumab--being developed in collaboration with Bristol-Myers Squibb--had failed one of the studies in patients with advanced melanoma. The trial failure hasn't shaken researchers resolve to move forward with the drug, though. The companies are saying that all of the data combined with the lack of options for patients should make a good case for approval. Investors weren't as confident, shaving about 18 percent off of Medarex's stock price on the news.

- see this release on the trial
- check out the AP report for more

ALSO: Kosan Biosciences also saw its stock price plunge after reporting that Phase Ib data for its blood cancer treatment tanespimycin appears to be worse than initially reported. Report

Related Article:
BMS misses a beat in cancer comeback. Report