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Luke Doiron
(256) 513-9705
luke.doiron@gmail.com
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just saw @conversantbio
Aug
19
Nanotubes, nanofibers tested as anticancer delivery depots
Jul
29
Despite the efforts of some anti-nanotech groups to paint carbon nanotubes as hazardous to human health, the reality is that they increasingly show promise as drug-delivery devices. The latest proof of that comes from researchers in Germany who showed that tubular nanomaterials, such as carbon nanotubes and carbon nanofibers, are promising delivery agents for anticancer drugs.
The researchers used the materials as drug depots to deliver the anti-cancer drug carboplatin in vitro. The result: No significant intrinsic toxicity of unloaded materials was found, confirming their biocompatibility. And carboplatin that was delivered by carbon nanotubes exhibited higher anticancer activity than free carboplatin.
It’s not anything conclusive. But that’s the way science works. One study builds upon another. It sounds like a better method of determining carbon nanotube toxicity than the anti-nano groups’ method of declaring all nanomaterials to be toxic.
Read the full story here.
Nanoblasts from laser-activated nanoparticles move molecules, proteins and DNA into cells
Jul
28
Using chemical “nanoblasts” that punch tiny holes in the protective membranes of cells, researchers have demonstrated a new technique for getting therapeutic small molecules, proteins and DNA directly into living cells.
Carbon nanoparticles activated by bursts of laser light trigger the tiny blasts, which open holes in cell membranes just long enough to admit therapeutic agents contained in the surrounding fluid. By adjusting laser exposure, the researchers administered a small-molecule marker compound to 90 percent of targeted cells – while keeping more than 90 percent of the cells alive.
The research was sponsored by the National Institutes of Health and the Institute of Paper Science and Technology at Georgia Tech. It will be reported in the August issue of the journal Nature Nanotechnology.
“This technique could allow us to deliver a wide variety of therapeutics that now cannot easily get into cells,” said Mark Prausnitz, a professor in the School of Chemical and Biomolecular Engineering at the Georgia Institute of Technology. “One of the most significant uses for this technology could be for gene-based therapies, which offer great promise in medicine, but whose progress has been limited by the difficulty of getting DNA and RNA into cells.”
The work is believed to be the first to use activation of reactive carbon nanoparticles by lasers for medical applications. Additional research and clinical trials will be needed before the technique could be used in humans.
Researchers have been trying for decades to drive DNA and RNA more efficiently into cells with a variety of methods, including using viruses to ferry genetic materials into cells, coating DNA and RNA with chemical agents or employing electric fields and ultrasound to open cell membranes. However, these previous methods have generally suffered from low efficiency or safety concerns.
Read the full story here.
Onyx will seek early approval on blockbuster cancer candidate
Jul
27
The multiple myeloma therapy carfilzomib registered a response in about one of four drug-resistant patients in a mid-stage trial, reports Onyx Pharmaceuticals, which the biotech believes is solid enough data to win an accelerated approval for a therapy with clear blockbuster potential. Onyx CEO Anthony Coles told reporters that a regulatory filing will be made before the end of this year.
The Phase IIb data on the proteasome inhibitor is a big win for Onyx, which scooped up the therapy when it acquired Proteolix in an $816 million buyout deal–with $276 million up front–just a year ago. And Coles says the drug could be on the market a year from now for the lethal cancer. “The unmet need in the population is so huge and the disease is almost uniformly fatal,” Coles told the San Francisco Business Times.
Researchers recruited 266 patients for the trial and found that 24 percent registered at least a partial response to the therapy. The median duration of response in patients was 7.4 months. But the company declined to say for now just how long patients taking the drug survived, notes the New York Times, waiting for the right scientific conference to detail that data. For now, the company will only say that it believes carfilzomib will prolong survival. Now Onyx’s blockbuster hopes will shift to the Phase III stage. Two late-stage trials are planned for the drug, including one study that will examine the effects of a combination of a low dose of the steroid dexamethasone and Revlimid with and without carfilzomib. A European Phase III study is also planned.
As Forbes’ Robert Langreth notes today, Onyx is anxious to score another blockbuster cancer drug approval to complement its success with Nexavar. Onyx has a unique status as the only sizeable standalone cancer drug developer, he adds, making the company a likely candidate for a rich buyout offer if it can come up with a new blockbuster therapy.
- here’s the release on the data
- read the story from the San Francisco Business Times
- see the report from Forbes
- here’s the story from the New York Times
Onyx Pharma calls myeloma data “impressive”
Jul
26
LOS ANGELES, July 26 (Reuters) – Nearly a quarter of trial patients with multiple myeloma that had stopped reacting to current drugs responded to an experimental cancer drug, carfilzomib, being developed by Onyx Pharmaceuticals Inc.
Onyx said it plans to use the single-arm study results, released on Monday, as the basis for a new drug application (NDA) at the U.S. Food and Drug Administration before the end of the year.
“We think these are very impressive data,” Onyx Chief Executive Officer Tony Coles told Reuters. “We expect to file an NDA by the end of this year.”
He said Onyx will seek an accelerated six-month review by the FDA based on the unmet need of the intravenous drug’s target population, as well as its efficacy and tolerability.
The mid-stage trial involved 266 severely ill multiple myeloma patients whose cancer had worsened after an average of five prior treatment regimens.
The study found that 24 percent of the patients responded to carfilzomib for a median duration of 7.4 months.
Coles said Onyx had expected a response rate for such heavily-pretreated patients in the mid-teens with a response duration of four to six months.
A study by the International Myeloma Working Group found that myeloma patients as sick as those enrolled in the Onyx study can expect to respond to therapy 11 percent of the time.
The company did not release full details of the trial, including side effects, but said the drug was well-tolerated and there were no new or unexpected toxicities.
Coles said about 50,000 American have multiple myeloma, a cancer the develops in cells of the bone marrow, and about 20,000 new cases are diagnosed each year. Around 20 percent of patients are considered “relapsed and refractory,” meaning that their cancer no longer responds to standard drugs including Takeda Pharmaceutical Co’s Velcade.
Onyx is also studying carfilozimb, a proteasome inhibitor, in patients with earlier-stage myeloma.
Onyx acquired carfilzomib developer Proteolix Inc last year for an upfront cash payment of $276 million and potential milestone payments of up to $535 million
Read the full story here at Reuters.
FDA asks NicOx for new naproxcinod trial
Jul
22
The FDA has issued a complete response letter asking NicOx to conduct another clinical trial of naproxcinod, a treatment for osteoarthritis. Earlier, an expert panel had voted 16 to 1 against the drug, saying that the French biotech had not offered solid evidence to prove that its painkiller did not raise blood pressure. Concerned about cardiovascular and gastrointestinal side effects of the drug, the agency has recommended that NicOx conduct one or more long-term controlled studies of the painkiller. Regulators also said the company should run other studies to demonstrate that the use of nitric oxide in the naproxcinod benefits patients. No clinical efficacy studies were requested.
The Paris-based company didn’t indicate what it would do next, but said in a statement that it will meet with the FDA as soon as possible to discuss further steps for naproxcinod. The drug is still under review in the EU. NicOx had €138.5 million in the bank at the end of March 2010.
- here’s the NicOx release
- read the BusinessWeek report
Pfizer stops two more trials of pain drug tanezumab
Jul
22
Pfizer has been forced to halt two more trials of tanezumab, an experimental biologic for pain. The FDA requested that Pfizer suspend two late-stage trials of the drug in patients with chronic low back pain and painful diabetic peripheral neuropathy. The move comes after the drug giant suspended another trial of the biologic in June. In that study, patients taking the therapy for osteoarthritis saw their condition worsen to the point they required joint replacement surgery.
The FDA told Pfizer to halt the trials following reports of further adverse events in patients enrolled in the suspended osteoarthritis study. The agency was concerned that those events would also crop up in Pfizer’s other studies of tanezumab. The developer says it will continue to work with the FDA to determine how best to proceed with the rest of its tanezumab studies.
Tanezumab is an infused biologic which is designed to block pain by inhibiting nerve growth factor. If approved, it would be the first biotech therapy for pain. According to Pfizer’s statement, investigation of the compound is ongoing in some areas of high unmet medical need, including cancer pain.
- take a look at Pfizer’s announcement
- read here for more
iPSC use may be limited by ‘memory
Jul
21
Two independent teams of scientists have concluded that induced pluripotent stem cells (iPSCs) don’t behave exactly like the stem cells found in early human embryos that are just a few days old. Investigators at the Massachusetts General Hospital Center for Regenerative Medicine have confirmed that iPSCs retain some characteristics of the cells from which they were derived–something that could both assist and impede potential clinical and research uses. In their report to be published in Nature Biotechnology, the researchers also describe finding that these cellular “memories” fade and disappear as cell lines are cultured through successive generations.
The findings may pose a challenge to previous research that suggested these reprogrammed cells may be substituted for embryonic stem cells, Bloomberg points out. However, researchers are already developing ways to get around the limits identified in the study, so the iPSCs can be used to treat certain conditions. “It’s a challenge to be understood and overcome,” George Daley, a researcher at the Harvard Stem Cell Institute and Children’s Hospital in Boston and lead author of a separate Nature study, told Bloomberg over the phone. “We already have strategies for overcoming this.”
Still, the study results are a setback for the field of regenerative medicine, in which stem cells are used to grow new body tissues aimed at repairing or replacing body parts damaged from injury or illness, Bloomberg notes. “How faithfully iPSCs can be reprogrammed into a truly embryonic state has been a longstanding question, and we have found that the cell of origin does affect the capacity of iPSCs to differentiate in vitro into particular cell types,” says Konrad Hochedlinger of the MGH Center for Regenerative Medicine in a statement. “But when cultured iPSCs go through many rounds of cell division, they lose that memory.”
-Read more: here
- check out Bloomberg‘s coverage
- read more from the Independent
Amgen’s Prolia wins priority review for cancer use
Jul
20
Amgen’s great new hope–the bone drug Prolia–won priority review at the FDA for a new, potentially lucrative cancer indication. The use: cancer that has spread to bone. The upshot: an approval could boost sales of the new drug to roughly $3 billion by 2015, analysts say.
Prolia won the FDA nod as an osteoporosis treatment June 1. But the drug isn’t expected to vault to quick success in that market. After all, it’s crowded with alternatives such as Merck’s Fosamax, which recently went generic, and Roche’s Boniva. Recently, Decision Resources predicted that the drug could build to just $500 million in osteoporosis sales by 2019.
Amgen is really counting on pushing Prolia as a treatment for cancer patients. That’s why it submitted data for this second indication even before it won FDA’s initial approval. The sooner it can get a cancer approval, the sooner it can start touting Prolia to a very receptive market. With this priority-review designation, that date could be as soon as November 18.
- get the release from Amgen
- read the PharmaTimes story
-More here.
Researchers use nanoparticles to shrink tumors in mice
Jul
19
It’s nice to see some good news for lab mice, since good news for them can lead to good news for us–in this case, for cancer patients. Researchers at UCLA grabbed a few white, furry “volunteers” and implanted human cancerous tumors in them. Then, a promising thing happened. The researchers injected the mice with mesoporous silica nanoparticles (MSNs), tiny particles with thousands of pores that can carry the anti-cancer drug camptothecin, and the mice came out of it with clean bills of health.
This has been a longtime goal of nanobiotechnology — the ability to tailor a nano-sized drug delivery agent for a specific purpose, drop its payload only on the bad cancer cells and then safely make its way out of the body.
“Two properties of these nanoparticles are important,” said Jie Lu, a postdoctoral fellow. “First, their ability to accumulate in tumors is excellent. They appear to evade the surveillance mechanism that normally removes materials foreign to the body. Second, most of the nanoparticles that were injected into the mice were excreted out through urine and feces within four days. The latter results are quite interesting and might explain the low toxicity observed in the biocompatabilty experiments we conducted.”
Researchers at UCLA’s California NanoSystems Institute and Jonsson Comprehensive Cancer Center demonstrated the technology in a paper published in the July 8 edition of the appropriately named journal Small. The next step: extensively test the MSNs in a variety of animal-model systems and make sure it’s all safe for the non-mouse world.