Showing posts with label fails. Show all posts
Showing posts with label fails. Show all posts

Monday, July 1, 2013

UPDATE 2-Ziopharm cancer drug fails in trial; shares plunge 66 pct

* Company to halt drug development for soft tissue sarcoma

* Says will focus on synthetic biology drugs

(Adds CEO comment from conference call, analyst comment)

By Vrinda Manocha

March 26 (Reuters) - Ziopharm Oncology Inc will stop developing its drug to treat soft tissue sarcoma after it failed to improve patients' survival without the cancer worsening, wiping out nearly two-thirds of its market value.

The drug, palifosfamide, was being tested in a late-stage trial as a treatment for metastatic soft tissue sarcoma - a type of cancer of the bone, cartilage, fat or muscles.

"We know that based on progression-free survival, there is no way the drug will get approval anywhere in the world," Chief Executive Jonathan Lewis said.

The company will now evaluate all its palifosfamide programs and convert its late-stage study of the drug in small cell lung cancer to a mid-stage trial, he said.

Ziopharm said it would now focus on its synthetic biology program, which creates DNA-based drugs that enable controlled delivery of genes that produce proteins to treat cancer.

The palifosfamide sarcoma trial involved 447 patients with metastatic soft tissue sarcoma across 150 centers.

The patients received either palifosfamide along with doxirubicin - an approved cancer drug - or doxirubicin alone.

An independent committee recommended that the patients be followed to test the improvement in their overall survival, but the company said it does not expect to continue the follow-up.

Brinson Patrick Securities analyst Vernon Bernardino said the company's decision to stop the drug's development was "drastic" but noted that the company had "burned" a lot of money on the project.

"They obviously need to restructure expenses to meet the needs of what has the best chances of success and they believe more in the synthetic biologic program," Bernardino said.

Ziopharm is testing its lead drug in this program in two mid-stage trials for the treatment of melanoma and breast cancer.

However, Bernardino said he ascribed a very low value to the synthetic biology program and that it accounted for only 3 percent of his share-price target of $7.

The company's shares fell 66 percent to $1.76 in early trading -- their lowest in more than three years.

(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Maju Samuel)

((esha.dey@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ZIOPHARM STUDY/CANCER


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Monday, April 22, 2013

UPDATE 1-Italy's Gentium fails to wins EU backing for key drug

(Adds details on drug, background)

LONDON, Feb 21 (Reuters) - Italian biotech company Gentium

has failed to convince European regulators of the benefits of its most advanced drug candidate, dealing a blow to prospects for the rare liver disease treatment.

Gentium said on Thursday it expected an opinion recommending against approval of defibrotide from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

"While not a final decision, the company considers it unlikely that this position will change before the formal vote is undertaken next month," Gentium added in a statement.

"If a formal negative recommendation is issued, and depending upon the nature of the objections, the company may appeal such negative decision."

Investor hopes have been pinned on defibrotide since it would be the first drug approved for hepatic veno-occlusive disease (VOD), a rare a condition in which some veins in the liver are blocked as a result of cancer therapy given prior to stem cell transplants.

Gentium's drug, based on single-stranded DNA extracted from pig intestines, has not yet been approved by the U.S. Food and Drug Administration.

(Reporting by Ben Hirschler; editing by Andrew Callus)

((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GENTIUM EUROPE/


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Thursday, May 10, 2012

Tech at Night: Oracle wins Java infringement suit against Google, ACTA fails in the EU, CISPA opponents silent on Lieberman-Collins UNEXPECTEDLY!

Tech at Night

Well, here we are. The reason CISPA was getting all the attention was allegedly that it was coming to a vote first. Well, now Lieberman-Collins is next to a vote, as Democrats scramble to find a way to make cloture. Where’s the outrage? I’ll tell you where it is: non-existent, because CISPA opposition was solely designed to give cover for Lieberman-Collins.

We do need the private sector to have more information, though. Internet attacks aren’t going away.

Wireless data and innovation are threats and great drivers of competition. We need less regulation if we want competition. Smaller government. Telecommuncations Act, not Obama FCC.

And so naturally we have Al Franken wanting Comcast to be targeted and the Germans wanting Verizon to be targeted. They just don’t get liberty.

That’s why the radicals passed Net Neutrality, whose insanity is so well summed up like so: “Meaning the hospital downloading a dying patient’s MRI gets no more broadband speed than the guy next door downloading the panda sneezes video on YouTube.”

The EU seems likely to block ACTA, in a victory for copyright infringers abroad.

Speaking of infringers, Android was built on copyright infringement in the form of Google stomping all over Oracle’s Java copyrights. Yes, Android’s VM is the issue here. That’s why Oracle wants a billion dollars. This is a big deal.


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