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Posts Tagged ‘gene-therapy’

TODAY’S HEADLINES:

luminous-medical-logo-150px.gifLuminous Medical raises $24M for automated glucose monitoring – Carlsbad, Calif.-based Luminous Medical, a medical-device maker, raised $23.5 million in a second funding round. Investors included Adams Street Partners, RiverVest Venture Partners, Finistere Ventures, De Novo Ventures and Latterell Venture Partners.

Luminous is developing an automated blood-sugar sensor for diabetic patients being treated in hospital intensive-care units and operating rooms. According to the company, keeping a tight rein on blood-glucose levels, which can soar or crash unexpectedly in diabetics, helps prevent complications while shortening hospital stays and reducing the risk of death.

Measuring such tight control, however, typically requires manually checking blood-glucose levels every 30 to 60 minutes, the company says. The Luminous device, by contrast, uses infrared spectroscopy — a technique that identifies particular molecules by measuring which wavelengths of light they absorb — to measure glucose and other blood chemicals non-invasively.

The company licensed its technology from InLight Solutions of Albuquerque, N.M., which previously invested $60 million in the technology. The device has not been approved by the FDA.

axial-biotech-logo-150px.gifAxial Biotech takes in $6M for spinal diagnostics – Axial Biotech, a Salt Lake City diagnostic-test maker, raised $6 million as part of its second funding round. Investors included Johnson & Johnson Development, vSpring Capital and Ohio Biotech Group.

Axial, founded in 2002 by a group of spinal surgeons and geneticists, is an odd hybrid of biotech and devices. The company aims to produce tests that will predict and measure the severity of spinal problems such as scoliosis, as well as unspecified “motion-preserving technologies” — presumably an alternative to the stigmatizing back braces that orthopedists have long inflicted on children with the condition.

engene-logo-150px.gifInsulin bioengineer enGene receives $6.4M – Canada’s enGene, a Vancouver biotech looking for ways to jump-start natural insulin production in diabetics, raised $6.4 million in a first round of funding. Investors included Saad Investments, Masa Life Science Ventures and private investors.

EnGene has an audacious — which is to say, of course, also quite chancy — approach to diabetes, in which the immune system attacks and kills insulin-producing “beta cells” in the pancreas (type 1 diabetes) or the body grows desensitized to insulin and requires higher levels (type 2 diabetes). In either case, patients often require insulin shots to maintain blood-sugar levels necessary or proper metabolism.

EnGene proposes to engineer cells in the small intestine — known as “K cells” — to produce insulin themselves. The advantage of this technique lies in the fact that K cells, like beta cells, respond to sugar levels in the gut, although they normally secrete a separate molecule. Once bioengineered to produce insulin as well, these cells could help regulate blood sugar automatically much the way beta cells normally do.

Of course, gene therapy has, in general, been a great disappointment so far, so there’s no shortage of uncertainty associated with this sort of technique. EnGene has tested its technique in mice, but not yet in humans. The startup plans to seek a second round of funding in the second half.

Alimera Sciences gets $30M for eye-disease drug – Alimera Sciences, an Alpharetta, Ga., drug developer with a focus on eye disease, raised $30 million in a third funding round. The company will now take a majority stake in its drug for diabetic macular edema, a vision-degrading complication of diabetes, which Alimera is developing with its partner pSividia.

We’ve written before about Alimera, which is presumably still contemplating an IPO this fall. All five of the company’s existing VC backers participated in the round: BA Venture Partners, Domain Associates, Intersouth Partners, Polaris Venture Partners and Venrock Associates.

ligocyte-logo-150px.gifVaccine maker LigoCyte draws $28M – LigoCyte Pharmaceuticals, a Bozeman, Mont., biotech focused on new vaccines against infectious disease, raised $28 million in a third funding round. Investors included Forward Ventures, JAFCO, Novartis Venture Fund, Fidelity Biosciences, MedImmune Ventures, Athenian Venture Partners and MC Life Sciences Ventures.

The company is developing new vaccines using “virus-like particles” — usually structural viral proteins, minus the replication machinery packed in DNA or RNA — against gastroenteritis, anthrax and flu. It is also working on antibody drugs against inflammatory disease.

Featured companies: BioVascular, Carefx, ClinResearch, Healthcare Management Directions, NanoCor, OxyPlus, Revitus, Spotlight Surgical, United BioSource

UPDATED: See below.

carefx-logo.jpgHealthcare IT provider Carefx pulls in $17.9M — Carefx, a Scottsdale, Ariz., provider of hardware and software that “aggregates” patient records, has raised $17.85 million in a third funding round, Private Equity Hub reports, citing a regulatory filing. Investors included Carlyle Venture Partners and UV Partners.

Carefx’s pitch is basically the same as that from any system integrator — a term guaranteed to glaze eyes in most circumstances — in that they offer to tie together hospital-patient information that’s currently scattered across disparate computer systems. As with all system-integration pitches, it sounds like a terrific idea, if it works. Of course, many systems-integration efforts often only work after creating a significant amount of chaos and disarray within their respective organizations, which would certainly be interesting in critical-care areas such as the emergency room or intensive care. None of which to say that efforts to make electronic medical records more comprehensive and easier to use aren’t worthy, of course.

spotlight-surgical-logo.jpgMedical imager Spotlight Surgical pulls in $7.4M — San Francisco’s Spotlight Surgical, a maker of medical-visualization software, raised about $7.42 million in a second funding round, Private Equity Hub reports, citing a regulatory filing. Attractor Ventures led the round.

Secretive drug developer OxyPlus gets $8M — OxyPlus, a Boston biotech working on drugs for cancer and heart disease, raised $8 million in a first funding round, VentureWire reports (subscription required). Index Ventures provided the funding, which follows an undisclosed amount of angel seed investment.

From the VentureWire story:

Based in Boston, OxyPlus is developing compounds discovered by Claude Nicolau, a professor at the Universite Louis Pasteur in Strasbourg, France, and Jean-Marie Lehn, a professor at the College de France. [President Conrad] Bletzer said the company is keeping the scientific details under wraps, but the company’s drugs are being targeted for several high-profile indications. “They’re small molecules for the treatment of cardiovascular issues and cancer,” he said.

nanocor-logo.jpgMedtronic pumps up to $7.5M into heart treater NanoCor — Chapel Hill, N.C.-based NanoCor Therapeutics, a biotech working on gene therapy for heart failure, raised $3.75 million from Medtronic, with another $3.75 million dependent upon certain performance milestones.

For some reason, NanoCor doesn’t want to come right out and say it’s a gene therapy company — instead, it wants to create the first “intracellular genetic protein therapy” for heart failure. That amounts to the same thing, since the company plans to use some sort of nanoparticle to shuttle a “proprietary” and so-far unnamed gene to the heart, where it will be taken up by heart cells in order to begin producing some form of useful protein.

NanoCor plans to use nanoparticle technology from Asklepios BioPharmaceutical, or AskBio, from which NanoCor was spun out in 2005. Medtronic will have certain rights to license any resulting treatment.

Healthcare Management Directions gets almost $1.5M for “smart hospitals” — Brentwood, Tenn.-based Healthcare Management Directions, developer and would-be operator of “smart hospitals” with a heavy emphasis on IT systems and electronic records, raised just under $1.5 million in a first funding round following its 2004 recapitalization, VentureWire reports. Investors included Evergreen Investments and new and undisclosed individual and institutional investors. The funding will cover the firm’s investment in an Oklahoma facility it plans to manage.

Heart-drug developer BioVascular acquires Revitus for platelet drug — BioVascular, a San Diego biotech at work on anti-clotting drugs, acquired Revitus, another biotech working on similar drugs. Terms of the deal weren’t announced. Revitus was founded out of the Oregon Health & Science University in 2004.

United BioSource acquires controlling stake in ClinResearch — United BioSource, a Bethesda, Md., a provider of various services to the life-sciences industry, acquired a controlling stake in ClinResearch, a German firm with expertise in designing and conducting flexible, or “adaptive,” clinical trials. The companies didn’t announce financial terms.

UPDATE (1:00pm PT): Added items on NanoCor, Healthcare Management Directions, BioVascular/Revitus, and United BioSource/ClinResearch.

(UPDATED: See below.)

ceregene-logo.gifCeregene, a San Diego biotech at work on a gene therapy for Parkinson’s disease, has so far raised $28 million in a third funding round and last week struck a development partnership with Genzyme that resulted in a $25 million up-front payment and potential payments of another $125 million plus royalties.

Those are some surprisingly large numbers for gene therapy, the experimental practice of inserting new genes into the human body in hopes that their activity will make up for a defective or malfunctioning natural gene. The technique once served as a poster child for biotechnology’s promise of curing genetic disease, but crashed and burned when early efforts failed or, in a few tragic cases, proved harmful to patients. One infamous trial involving a rare genetic disease led to the 1999 death of 18-year-old Jesse Gelsinger, after which interest in the field dropped precipitously.

Now enthusiasm for gene therapy may once again — tentatively, at least — be on the upswing. Ceregene’s focus lies in genes that can deliver so-called neurotrophic factors, which are naturally occuring proteins that protect brain, spinal and nerve cells against damage, prevent programmed cell death, and stimulate the growth of new neurons.

While researchers have long considered neurotrophic factors a possible way to treat degenerative neural diseases such as Parkinson’s disease and Alzheimer’s disease, the proteins themselves don’t make promising drugs — largely because they’re too large to cross the blood-brain barrier. Some researchers have experimented with delivering similar proteins directly into the brain via invasive shunts or catheters, but the results have been unimpressive and the cost and difficulty of the procedure would likely limit its widespread use in any case.

Ceregene’s technology involves adeno-associated viruses that have been modified to carry genes for particular neurotrophic factors and disabled from reproducing naturally. These viruses are designed to carry the genes into at-risk cells — say, dopamine-producing neurons in Parkinson’s patients — and then “install” the carried gene into cellular DNA, where the cell’s own natural machinery will activate the gene and begin to produce neurotrophic factors.

In an early-stage trial involving just 12 Parkinson’s patients, administration of Ceregene’s gene therapy CERE-120 was associated with a 36 percent reduction in symptoms 12 months after the gene-loaded virus was injected into the volunteers’ brains. That trial didn’t have the most rigorous controls necessary to protect against investigator bias and placebo effect, so it’s impossible to draw too many conclusions from it. Ceregene is currently at work on a 51-patient follow-up trial that may produce data by the fall of 2008.

The promising results still intrigued Genzyme, an early pioneer in gene therapy for cystic fibrosis, who two years earlier had bought out much of the gene-therapy business of the struggling biotech Avigen, which also has a gene-therapy treatment for Parkinson’s disease.

Last week, Genzyme agreed to pay Ceregene 50 percent of the late-stage development costs for CERE-120 plus up to $150 million in cash in exchange for all rights to the treatment outside the U.S. and Canada. That’s a fairly hefty sum for a treatment that hasn’t even completed mid-stage trials and which also depends on such a relatively untested technique as gene therapy. Genzyme has other irons in the gene-therapy fire as well; today, Applied Genetic Technologies announced that it received $2 million from the big biotech as a milestone payment for its development of a gene therapy for a particular form of blindness.

Meanwhile, Ceregene has also raised $28.1 million in an open third funding round, VentureWire reports (subscription required). Investors in the round include Investor Growth Capital, Alta Partners, California Technology Ventures, Hamilton BioVentures, MPM Capital and Cell Genesys, Ceregene’s former corporate parent.

UPDATE: Added MPM Capital to the investors list, per Ceregene CEO Jeff Ostrove’s comment.

Applied Genetic Technologies, an Alachua, Fla., gene-therapy developer, received a $2 million milestone payment from Genzyme.

The two companies are jointly developing a gene therapy for treating a form of blindness called age-related macular degeneration. The treatment uses an adeno-associated virus designed to deliver a gene to eye cells that, when activated, will disrupt a protein called VEGF that stimulates the growth of leaky blood vessels that contribute directly to blindness.

The milestone payment covered the successful transfer of AGT’s adeno-associated virus production technology to Genzyme. The gene-therapy treatment doesn’t appear to be ready for clinical trials yet.

Intrexon, a Blackburg, Va., developer of engineered gene therapies it calls “transcriptional therapeutics,” raised $25 million in a third round of financing provided by Third Security. Earlier funding rounds were provided by Third Security and NewVa Capital Partners.

Intrexon is at work on drugs based on stretches of DNA that can integrate themselves into the genomes of individual cells and begin to function like native genes. These newly installed genes could be turned on or off by “activator” molecules such as another drug, potentially allowing the controlled production of new proteins that affect other cellular processes. Intrexon intends to direct the technology against cancer.

Such gene therapy has long been tantalizing, although it’s never worked particularly well in practice. The company’s release is here.

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