brain cancer

Northwest Bio says it is running out of cash

John Carroll — Wed, 20 Aug 2008 10:25:19 -0400

Northwest Biotherapeutics startled investors with the news that it has only $1.1 million of cash on hand--enough to fund operations through September. And assurances that the developer is in talks with a number of potential sources of funds needed to advance trials, pay off debt and fuel operations failed to reassure investors. Northwest Bio's shares lost half of their value. Northwest Bio is studying a brain tumor therapy in a clinical trial. The developer gained a million-dollar, six month loan from Toucan Partners.

--read the AFX story

Related Article:
Researchers explore brain cancer vaccine

ALSO NOTED: New vaccine/chemo combo effective in cancer study; Type 1 diabetes vaccine goes into human studies; and much more..

Thu, 29 May 2008 06:59:50 -0400

> Chutes & Ladders: Susan Windham-Bannister will take over as CEO of the Massachusetts Life Sciences Center Board. The board's function is to ensure the state retains its prominence in the life science industry. Report

> New trial data shows that the combination of a chemotherapy drug and a new vaccine significantly prolonged the survival of patients with glioblastoma, the aggressive brain cancer that now afflicts Senator Ted Kennedy. Vaccine report

> Denmark's Bavarian Nordic has launched a Phase I/II trial of an experimental HIV vaccine. Safety data from the study is expected by the end of this year with immunogenicity data following in the first half of next year. Report

> Researchers have begun human studies of a new vaccine that is designed to block or reverse type 1 diabetes. A team at Children's Hospital in Pittsburgh is loading microspheres with nucleic acid. Report

> Analysts are chatting up Gilead Science's HIV drug Viread as a treatment for hepatitis B. Report

> FDA is considering new, more detailed drug labeling aimed at pregnant and nursing women. FDA report

And Finally... Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Report

Antigenics gets world's first cancer vaccine approval

Tue, 08 Apr 2008 06:59:57 -0400

Russia has improbably emerged as a world leader in new cancer vaccines. The country's regulatory body approved the use of Antigenics' new kidney cancer vaccine, Oncophage--a world first. And shares of little Antigenics swiftly soared 23 percent on the news.

The FDA has not approved the therapy, one of the first of a wave of treatments that is intended to train the immune system to recognize and destroy cancer. Oncophage failed a clinical trial, but researchers found in a follow-up analysis of the data that patients taking the therapy lived 1.7 years longer without the cancer reoccurring. This is the first time Russia has approved a drug that was not yet OK'd in its country of origin.

- check out the release
- read the article from CNBC
- here's the AP story

Related Articles:
Big Pharma takes an interest in cancer vaccines. Report
Antigenics' cancer vax gets mixed Phase III results. Report
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

Peregrine reports positive cancer data

Tue, 11 Mar 2008 07:59:55 -0400

Peregrine Pharmaceuticals is posting positive data from two ongoing, mid-stage trials of its cancer therapy Cotara. The trial data assessed Cotara's safety and efficacy in treating patients with glioblastoma multiforme, a deadly form of brain cancer. The drug appeared to be safe and well tolerated, with no dose-limiting adverse events. And several volunteers surpassed the median expected survival time for relapsed GBM patients.

"In view of the short expected survival time of approximately six months in this patient population, it is promising that we have early GBM patients in these trials who have survived past the six-monthtimeframe, with one patient now surviving 15 months post-treatment," said Steven W. King, president and CEO of Peregrine.

- check out the release

Related Articles:
India OKs Peregrine trial. Report
Peregrine touts early avian flu virus data. 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

ALSO NOTED: Avastin delivers promising data for brain cancer; Genelabs regains development rights; and much more...

Mon, 19 Nov 2007 06:59:50 -0500

> A mid-stage study of Avastin shows promising results in treating a form of brain cancer. Release

> Genelabs Technologies says it's regained development rights to the experimental lupus drug Prestara from Mitsubishi Tanabe Pharma. Release

> Keryx Biopharma has presented early results from a mid-stage study of perifosine or KRX-0401 in patients with recurrent malignant gliomas. Release

> Here's some somber news: The FDA has tallied more than 200 reports of deaths linked to Trasylol, the suspended blood-clotting drug made by Bayer. Report

> Pfizer whistleblower Dr. Peter Rost (photo) will get his day in court. The U.S. Court of Appeals has overruled an earlier ruling, reinstating Rost's suit against the company. Report

> Poor Puerto Rico. Pharmaceuticals firms are shutting down plants in the U.S. territory, eliminating some 3,000 jobs. Report

> It looks like a drug, it acts like a drug, but if comes in a cosmetics tube instead of an eyedropper, is it still a drug? Lumigan, a glaucoma remedy sold by Allergan, has the unusual added benefit of promoting eyelash growth. Report

And Finally… The melatonin supplements that many people take to fight jet lag could have a down side inhibiting memory formation. Release

Avant, Celldex merge in $115M stock deal

Mon, 22 Oct 2007 06:59:56 -0400

Avant Immunotherapeutics is merging with Celldex Therapeutics in a stock deal valued at $115 million. Celldex shareholders will wind up with a majority of the shares in the merged company, which will have development programs in vaccines and brain cancer immunotherapeutics. The merged company will also have a product on the market--the oral vaccine Rotarix. Celldex is privately held and Avant's shares closed at 55 cents on Friday.

- see this release

Related Articles:
Avant cuts staff, biodefense work in restructuring. Report
Avant celebrates endpoint failure for TP10. Report
Avant in deal to develop vaccines. Report

Press Release: Eli Lilly and Company Stops Trial Of Brain Cancer Drug

Maureen Martino — Wed, 20 Dec 2006 11:10:36 -0500

Eli Lilly and Company Stops Trial Of Brain Cancer Drug

INDIANAPOLIS, Dec. 21 -- After reviewing data gathered to date, as part of a planned interim analysis, an External Data Monitoring Committee (DMC) has recommended that the STEERING trial (Study Evaluating Enzastaurin in Recurrent Glioblastoma) be closed for enrollment. The global Phase III study was evaluating enzastaurin for the treatment of an aggressive and recurrent form of brain cancer.

Results of this planned interim analysis suggested that enzastaurin would not meet the primary endpoint of improvement in progression-free survival over an existing chemotherapy in this particular study. Lilly accepted the DMC recommendation and immediately contacted all STEERING study investigators to inform them of the decision and to provide them all available information to manage patients.

"We are disappointed for patients suffering from recurrent glioblastoma, but we remain confident and committed to the development of enzastaurin," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Eli Lilly and Company. "Recurrent glioblastoma is a rare and difficult to treat tumor and patients and their families are seeking innovative treatment options. Given the independently validated response rate of 22-percent in a phase II trial, we plan to thoroughly review the data from this interim analysis and apply the insights learned to the glioblastoma program. Based on preclinical and clinical evidence, the company also remains fully committed to the continued development of enzastaurin."

Enzastaurin is being evaluated in a Phase III trial (currently enrolling patients) as a maintenance therapy for the treatment of non-Hodgkin's lymphoma as well as being evaluated in several phase II studies across a variety of more common tumor types including: breast, colon, lung, ovarian and prostate cancers. These additional trials are unaffected by the DMC recommendation.

Enzastaurin

Enzastaurin is a potent multi-kinase inhibitor which targets selectively the PKCbeta and PI3/AKTsignaling pathways. By blocking these key pathways frequently over-expressed in a wide variety of cancers, enzastaurin suppresses tumor cell proliferation, induces tumor cell death and inhibits tumor-induced angiogenesis. As further evidence to the rare and unmet medical need of recurrent glioblastoma, enzastaurin was granted orphan drug designation by the European Agency for the Evaluation of Medicinal Products (EMEA) and by the U.S. Food and Drug Administration's Office of Orphan Products Development for the treatment of glioblastoma.

Background on STEERING Trial

The STEERING trial (Study Evaluating Enzastaurin in Recurrent Glioblastoma) is a randomized, open label registration study in recurrent glioblastoma multiforme (GBM) comparing the efficacy and safety of enzastaurin, taken orally, versus CeeNU(R) (lomustine[CCNU]), a chemotherapy used to treat this disease. The primary endpoint is improvement in progression-free survival.

Glioblastoma

Glioblastoma is the most aggressive and malignant form of glioma, a type of primary brain cancer. In the early stages, glioblastoma tumors often grow quickly and without symptoms, becoming quite large before signs of altered brain function arise. Surgery is generally the first line of treatment, followed by radiation and/or chemotherapy. Although primary treatment is often successful in temporarily stopping the progression of the tumor, glioblastomas almost always recur and survival rates remain low.

Data Monitoring Committee

A Data Monitoring Committee (DMC) is an independent body consisting of physicians and statisticians. Their responsibility is to review interim analysis data from clinical trials and make a decision on whether the trial is still set up correctly or needs any modifications.

Lilly Oncology, a Division of Eli Lilly and Company

For more than four decades, Lilly Oncology has been collaborating with cancer researchers to deliver innovative treatment choices and valuable programs to patients and physicians worldwide. Inspired by the courageous patients living with cancer, Lilly Oncology is providing treatments that are considered global standards of care and developing a broad portfolio of novel targeted therapies to accelerate the pace and progress of cancer care. To learn more about Lilly's commitment to cancer, please visit http://www.LillyOncology.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.

O-LLY

This press release contains forward-looking statements about the potential of the investigational compound enzastaurin and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

SPOTLIGHT: India OKs Peregrine trial

Wed, 11 Oct 2006 20:01:33 -0400

India has given Peregrine Pharmaceuticals a green light to conduct clinical trials of its experimental therapy Cotara for a type of brain cancer. "We believe this new clinical trial will be a cornerstone of our future plans to develop Cotara for the treatment of this deadly form of cancer," said Steven W. King, president and CEO of Peregrine. "We are moving this program forward in India because of the high level of experience of the participating neurosurgeons with CED delivery, the state-of-the-art facilities of the medical centers involved and the fact that the contract research organization overseeing the trial is highly experienced in successfully running similar glioblastoma trials with many of the investigators who will be involved with our study." Release

Schering-Plough to pay $435M in fines

Tue, 29 Aug 2006 20:01:39 -0400

Plagued by allegations that the company engaged in illegal marketing tactics and overcharged Medicaid for its drugs, Schering-Plough has agreed to pay $435 million to resolve criminal and civil investigations. Of that, Schering-Plough will fork over $255 million to settle civil claims while its subsidiary, Schering Sales Corp., will pay $180 million in criminal fines while pleading guilty to a conspiracy to lie to government investigators probing the marketing of a brain cancer drug.

"With this agreement, we are putting issues from the past behind us," said Brent Saunders, senior vice president for compliance and business practices. Just two years ago, Schering-Plough agreed to pay $346 million to resolve claims that it engaged in a kickback scheme with a health insurer to protect its market for Claritin. Schering-Plough has been just one of a number of high profile drug companies accused of illegally manipulating the market--claims that have severely tarnished the reputation of the entire drug industry.

- read the Boston Herald's report for more

ALSO NOTED: Myogen's ambrisentan gets fast tracked; Eli Lilly initiates Phase III trial; and much more...

Wed, 08 Mar 2006 19:00:50 -0500

> The FDA has granted fast track designation to ambrisentan, Myogen's pulmonary arterial hypertension drug. Release

> Eli Lilly has initiated a Phase III study of Enzastaurin, a possible treatment for relapsed glioblastoma multiforme (GBM), an aggressive and malignant form of brain cancer. Release

> Generic drugmaker American Pharmaceutical Partners has received two tentative approvals from the FDA for Ondansetron Injection, USP, single-dose and multiple-dose vials, the generic equivalent of GSK's Zofran. The injection treats nausea and vomiting associated with cancer chemotherapy. Release

> The FDA has given the go-ahead for Kamada to initiate Phase III trials for API, lung disease treatment. Report

And Finally... If you drink three or more cups of coffee, you might want to put the coffee cup down and step away from the pot. Researchers have found that coffee increases the risk of heart attack in those who metabolize caffeine slowly. Article

ALSO NOTED: Chlorogen raises $6M in VC; Antisense receives approval to restart Phase IIa trial; and much more...

Thu, 19 Jan 2006 19:00:50 -0500

> Chlorogen has raised $6 million series B funding. The company will use the investment to finance development of its lead product candidates, which include protein-based therapies for gynecological cancers. Release

> Antisense Therapeutics has received approval from the Ethics Committee of the University of Essen in Germany to restart the Phase IIa trial of its antisense compound, ATL1102, for patients with relapsing-remitting multiple sclerosis. Release

> The FDA is questioning whether GlaxoSmithKline's Xenical can be sold safely over the counter. Report

> Takeda has begun Phase II clinical studies of ATL-962, a treatment for obesity and related diseases. Release

> SuperGen has withdrawn its marketing application for Orathecin from the European Medicines Agency (EMEA). Orathecin is an investigational drug for the treatment of pancreatic cancer. Release

And Finally... Isn't it nice to know your cell phone won't give you brain cancer? Article

Temodal effective in prolonging brain cancer survival

Sun, 30 Oct 2005 19:01:38 -0500

Results from a clinical trial of Temodal show that patients suffering from one of the most common forms of brain cancer demonstrated prolonged survival time. Patients taking Temodal capsules in combination with radiation therapy lived a median 18.3 months compared to 14.2 months from radiation therapy alone after surgery. The data was presented at the European Cancer Conference.

"Our expectations were exceeded in this study, particularly among patients who underwent complete resection followed by Temodal and radiation therapy. Median patient survival increased as much as four months in this study, which is a benefit for patients living with this devastating disease," said Dr. Martin van den Bent, M.D., Ph.D., head of the Neuro-Oncology Unit, Daniel den Hoed Cancer Center, Erasmus University Medical Center, Rotterdam, the Netherlands, and a principle study investigator.

- read this press release for more information

Regulators agree to review new gene therapy

Thu, 27 Oct 2005 20:01:35 -0400

EU drug regulators have agreed to review Cerepro, a gene therapy for brain cancer developed by Ark Therapeutics. Ark has presented data that Cerepro can almost double the expected survival times of brain cancer victims.The therapy works by stimulating an enzyme that kills cancer cells.

- read this press release for more information

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

Tysabri linked to new infection

Sun, 12 Jun 2005 20:01:38 -0400

Biogen Idec and Elan have been hammered yet again by reports linking Tysabri to a deadly form of brain cancer. The Wall Street Journal reports that a possible fifth case of PML has been discovered. Their stock had been recovering based on optimistic projections that the two drug developers could create an acceptable strategy for returning the therapy to market while monitoring patients for symptoms of PML. Some analysts say that appears to be increasingly unlikely as more cases of possible PML are reported. Tysabri had been on its way to becoming the leading treatment for multiple sclerosis when it was withdrawn after two cases of PML were confirmed.

- read this story from Businessworld for more

ALSO NOTED: GW Pharma must mount new trials; Elan shares surge on Tysabri strategy; and much more...

Thu, 09 Jun 2005 20:00:50 -0400

> GW Pharma confirmed reports that regulators will require the company to mount new clinical trials to confirm the safety of its cannabis-based Sativex. Story

> Shares of Elan and Biogen Idec surged late Thursday after the New England Journal fo Medicine quoted doctors for Biogen discussing strategies to return Tysabri to the market while protecting patients from a possible brain infection. Story

> The European Commission has approved Schering-Plough's Temodal for first-line use for the treatment of newly diagnosed glioblastoma multiforme, the most common and aggressive form of primary brain cancer. Release

> The FDA has extended its review of Insmed's Somatokine for three months, until October 3. Release

And Finally... Drug makers believe a proposed new law on patents could make life harder for the industry. Story

Guilford cuts jobs in restructuring

Tue, 24 May 2005 20:01:37 -0400

Guilford Pharmaceuticals is cutting 38 jobs and refocusing its efforts on two products: a treatment for brain cancer and the experimental anesthesia Aquavan. Guilford said that it would continue to support the heart disease therapy Aggrastat as it sought to license, sell or partner on the treatment. But only "minimal" funds would be used to promote the drug. Aggrastat earned $12.5 million in revenue last year. Its hopes for future success lie with Aquavan, which the company believes could be submitted for approval next year.

- read this story from the AP for more on the restructuring