Pfizer’s targeted drug knocks out child cancers in small study

Posted under ASCO, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, non-small cell lung cancer, Pfizer, Pharmaceuticals, Pipeline, Startups, Universities, Videos, Xalkori by John Carroll

Some of the biggest headlines coming out of the massive ASCO abstract release aren't focused on a promising experimental treatment. They're about Pfizer's ($PFE) recently approved treatment Xalkori. Now targeted at non-small-cell lung cancer tumors with ALK gene abnormalities, Xalkori was tested in children with rare cancers also linked to those defects. And its success in those kids illustrates how targeted drugs can progress beyond their initial uses to other cancers with similar genetic characteristics. FiercePharma's Tracy Staton reports on the ASCO news in our team coverage. Report

FDA withdraws hold on GTx’s prostate cancer drug

Posted under Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, FDA, Funding, GTx, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Prostate Cancer, Regulatory, Startups, Universities, Videos by rmcbride

GTx ($GTXI) is back on track to begin a mid-stage study of its drug Capesaris. The FDA lifted a clinical hold on the experimental cancer drug after reviewing the company's response and plans for a Phase II study involving patients with castration-resistant prostate cancer.  

Memphis-based GTx now aims to launch the mid-stage trial in the third quarter, testing the drug in 75 men at three lower doses, the company said today. The study aims to measure safety and efficacy of the hormone therapy in men with aggressive prostate cancers.

U.S. regulators placed the program on hold in February after GTx revealed to the agency an increased risk of clotting. The safety risk was seen in patients treated with higher doses of the drug than the company plans to test in the revamped Phase II trial. The upbeat development pushed the company's stock price up nearly 20% to $3.72 this morning, helping the price regain some lost ground since the clinical hold made news.

GTx also said today in a corporate update that the company is enrolling patients for two late-stage studies of Ostarine for combating muscle wasting in patients with advanced non-small cell lung cancer. The update included results for the first quarter, which said that the company had $64 million in cash equivalents and other short-term investments as of March 31.

- here's the release on Capesaris
- see Reuters' update

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GTx shares tumble after clot threat forces hold on prostate cancer drug

Aveo Pharma flunks Phase II lung cancer study

Posted under AVEO Pharmaceuticals, Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, ficlatuzumab, Funding, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Phase II, Startups, tivozanib, Universities, Videos by rmcbride

Aveo Pharmaceuticals ($AVEO) missed the main goal of a mid-stage study in Asia of its drug ficlatuzumab for treating non-small cell lung cancer. The Cambridge, MA-based drug developer said patients treated with a combination of the drug and gefitinib didn't show a statistically significant response when compared with patients who got gefitinib alone.

Aveo's share price slid a modest 30 cents, or 2.53%, to $11.77, as of 10:30 a.m. ET Wednesday.

For Aveo, the big attraction remains the company's lead drug tivozanib, for which executives aim to request FDA approval as a treatment for aggressive kidney cancer later this year. The promise of that program has likely cushioned the blow from the failed ficlatuzumab study.

The Phase II study failed to achieve its primary endpoint of improvement in overall response rate. The overall response rate for a group of patients who took Aveo's antibody drug in combination with gefitinib, which AstraZeneca ($AZN) markets as Iressa, was 43%, just a bit higher than the 40% overall response among patients took only Iressa to combat their lung cancers. Patients on the combo treatment lived for 5.6 months without their cancer getting worse compared with 4.7 months in the gefitinib-only group, according to Aveo.

The study appears have identified a subset of patients who benefited significantly from the combo treatment, and senior investigator Dr. Tony Mok of The Chinese University of Hong Kong says the finding warrants further study. 

- here's the release
- see Reuters' coverage

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Tesaro promises rapid progress with cancer drugs in $86M IPO

Posted under Biotech IPO, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, rolapitant, SEC filing, Startups, Tesaro, TSR-011, Universities, Videos by John Carroll

Tesaro has put together an SEC filing that makes one essential promise to prospective investors interested in buying in on its $86 million IPO: This company is built for speed.

In less than a year, the developer boasts, it in-licensed rolapitant and pushed the cancer treatment into a Phase III study, with an eye to delivering top-line data in the second half of next year. An IND for TSR-011 as a new therapy for non-small cell lung cancer, in-licensed from Amgen ($AMGN) in the spring of last year, is being prepped for filing in the second half. Executives--experienced veterans of MGI Pharma, which fetched close to $4 billion--are forging an accelerated pathway aimed at reducing the time it takes to reach the market. Meanwhile, more in-licensing is planned as they build out a pipeline of cancer drugs for a global marketplace. And they plan to use their connections in the cancer drug world along with substantial venture backing to make that happen.

To get to this point, Tesaro has burned slightly more than $25 million from investors like NEA and Kleiner Perkins. But CEO Lonnie Moulder and his co-founders--chief scientist Mary Lynne Hedley and financial chief Rick Rogers--grabbed the industry's attention with its ability to raise $121 million in short order. Their quick success and emphasis on speed earned a Fierce 15 award in 2011.

Tesaro, though, has a set of negatives shared by everyone at this stage: No product revenue, high-risk R&D work, and only a two-year track record. That's been more than enough to chill the average investor on biotech IPOs over the past three years. Now the veteran team can see if experience and a bold timetable can warm up their prospects on Wall Street.

It should be interesting to see if their formula for success can bridge troubled market waters to a successful IPO.

- here's the S-1
- read the report from The Wall Street Journal

Special Report: Tesaro - 2011 Fierce 15

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