gene therapy

Ark shares soar on gene therapy data

John Carroll — Thu, 31 Jul 2008 12:11:44 -0400

A late-stage study of Ark Therapeutics' gene therapy for cancer posted significant survival benefits for volunteers with operable high grade glioma, sending its stock soaring 69 percent on the news. The group given a combination of Temodar, the best selling brain cancer drug, and Cerepro posted a 68 percent average improvement in survival in Phase III compared to standard care. A group given Cerepro alone posted a 50 percent improvement in survival. The Cerepro group lived an average of 42 days longer.

Analysts seemed divided, though, whether Ark had sufficiently made its case for the drug. A few weeks of extra life may not be enough to convince some governments around the world to pay for the therapy. But the full benefits have yet to be established.

- here's Ark's release
- read the report from the Financial Times

Introgen files first gene therapy for FDA approval

John Carroll — Tue, 01 Jul 2008 10:35:21 -0400

After 14 years of research, Introgen Therapeutics is asking the FDA to give its BLA for a gene-based therapy for head and neck cancer--Advexin--a priority review. Experts in the field told the Austin American-Statesman that Introgen had reached a major milestone by filing the first application for a gene-based therapy. The company is already seeking an approval in Europe.

Advexin works by using an inactivated cold virus to deliver the p53 suppressor gene into cancer cells. And the data indicates that the drug only works on people with low levels of the p53 gene. Nevertheless, two thirds of patients with head and neck cancer were able to take the drug in clinical trials.

"When you are able to provide and deliver into the tumor the correct gene function that is missing or defective," said Introgen SVP Robert Sobol, "that is treating a disease at its most basic and fundamental level."

- see Introgen's release
- read the story from the Austin American-Statesman

Florida coffers going dry as lawmakers deny funds

Wed, 30 Apr 2008 06:59:54 -0400

Lawmakers in Florida have opted against pumping a fresh $25 million into its Innovation Incentive Fund, one of the most singularly successful economic development programs in the world. The Fund has shelled out $450 million in just two years, funding an astonishing range of programs: a genomics institute at the University of Miami, satellite campuses for the Burnham Institute for Medical Research, bringing SRI International to Tampa, luring the Max Planck Society as well as the Torrey Pines Institute for Molecular Studies and the Vaccine and Gene Therapy Institute.

There has been some growing resentment that the fund is too focused on biotechnology. But the research groups that have been wooed with a combination of state and local cash say that unique focus will pay off with a new generation of biotech companies that will grow up in the Sunshine state.

- read the story in the Miami Herald

Is Sanofi preparing a bid for Oxford BioMedica?

Tue, 12 Feb 2008 06:59:57 -0500

Investors have focused their attention on Oxford BioMedica, a struggling UK developer that is the hotly rumored takeover target of Sanofi Aventis. Speculation about a possible buyout drove up Oxford BioMedica stock by 27 percent on Monday as analysts did the math on a possible deal. The company right now would probably fetch around $547 million, analysts tell the Financial Times. But a successful development program for the cancer vaccine TroVax would cost Sanofi--which partnered on the therapy--$753 million. Phase III data on TroVax is due next year while with Phase I/II data this year for a gene therapy aimed at Parkinson's.

"Sanofi Aventis has committed about £350 million and if everything is successful they are never going to pay this when the company is so cheap at the moment," says Navid Malik, an analyst at Collins Stewart. The companies, though, aren't saying anything for now.

- check out the article from the Financial Times

Related Articles:
Rumor Mill: Sanofi to buy Oxford BioMedica. Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

Merck's HIV vaccine linked to higher infections rate

Thu, 08 Nov 2007 06:59:54 -0500

Merck researchers have gone deep into the data for its recently shelved HIV vaccine and found evidence that the therapy may have actually made patients more likely to get an infection. Looking at the results of a study of 3,000 volunteers, researchers found that 49 of 914 people receiving the vaccine were infected with HIV compared to the 33 infections recorded among the 922 people in the placebo arm. The trial was shuttered after researchers concluded that the Merck vaccine had failed to reduce HIV levels or prevent infections.

"We don't really know the reasons for this," Keith Gottesdiener, vice president of vaccine and infectious-disease clinical research at Merck, told the WSJ. "We're still studying very hard to try to understand why that might have occurred."

- read the report from The Wall Street Journal

Related Articles:
Merck halts study of "ineffective" HIV vaccine. Report
New advances made in gene therapy for HIV. Report

Nobel Prize goes to gene targeting trio

Mon, 08 Oct 2007 06:59:57 -0400

As a child, Mario Capecchi spent four years on the streets in his native Italy, surviving by stealing or begging for food. Today, he's one of three scientists--the other two are Oliver Smithies and Sir Martin Evans--who've won the Nobel prize for medicine, recognition for their collective work on gene targeting, a process that allows researchers to turn genes off and on in mice. Their work involved introducing a genetic alteration in embryonic stem cells which are then injected into a mouse embryo. That development has spurred a huge advance in understanding the role of genes and health--and advanced a myriad number of therapeutic programs.

- see the release from the Nobel Assembly
- read the article from the New York Times

Related Article:
Gene therapy makes a big comeback. Report