Clinical Trials

IRX Therapeutics raises $25M Series A

Tue, 03 Jun 2008 06:59:55 -0400

New York-based IRX Therapeutics announced that it has raised $25 million in a Series A. The new money will be used to further develop IRX's cancer and viral disease product platform, including IRX-2 (citoplurikin), its lead candidate for cancer treatment. IRX researchers are developing a therapy that stimulates a coordinated cellular immune response that can enable a patient's own immune system to fight disease. IRX has reported positive mid-stage data and say they plan to launch a late-stage trial.

- check out IRX's release

ALSO: Canada's Inimex Pharmaceuticals has rounded up $22 million in venture funds to conduct the first clinical trials of its IDR drugs. Report

Genetic mutation will narrow target cancer groups

Mon, 02 Jun 2008 06:59:55 -0400

The K-ras gene is coming in for some star treatment at the ASCO meeting in Chicago. The gene plays a key role in several cancers, and new research indicates that the common genetic mutation makes Erbitux useless for slightly more than a third of all patients who may currently qualify for the drug.

The Wall Street Journal notes that the genetic signpost is helping R&D teams design clinical trials for new cancer drugs, using the genetic information to help them identify patients most likely to respond. The developers will benefit by increasing their shot at producing statistically significant data but will likely have to scale back the potential size of their market--a trade-off that payers in the U.S. will be glad to see.

- read the article in the Wall Street Journal

Sonus, OncoGenex to merge

Wed, 28 May 2008 06:59:58 -0400

Bothell, WA-based Sonus Pharmaceuticals is merging with Canada's OncoGenex Technologies and will operate under the name OncoGenex Pharmaceuticals. OncoGenex's CEO Scott Cormack will head up the new company.

Sonus has been struggling since September when it pulled the plug on its lead therapy for breast cancer. Since then the company said it has been looking for ways to rebuild shareholder value. A merger with OncoGenex was the best way to do that, CEO Michael Martino said in a release.

The combined company has a strong oncology pipeline with three candidates in various stages of clinical development. Its lead candidate, OGX-011 for prostate cancer, is being evaluated in five Phase II clinical trials.

- see the merger release

Pfizer gets new cancer team to advance key drugs

Thu, 15 May 2008 06:59:56 -0400

With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies.

Garry Nicholson, a 30-year Eli Lilly vet, will be responsible for overseeing every aspect of Pfizer's new oncology programs, from the first clinical trial to marketing, notes Forbes. Neil Gibson, formerly chief scientific officer at biotech OSI Pharmaceuticals, has been brought in to direct oncology research. And Briggs Morrison, who was able to speed clinical trials at Merck, has been brought in to do trial design.

"It's an exceptional situation," says Nicholson. "And for someone like me, who is in the business to get as many cancer drugs that extend survival to patients as possible, it is the best situation that I know of."

Pfizer needs all the help it can get. The drug giant is likely to lose 25 percent of its current revenue to generic competition for Lipitor.

- see Pfizer's statement on Nicholson's appointment
- read the article from Forbes

EmergingMed matches patients with clinical trials

Wed, 14 May 2008 06:59:55 -0400

Recruiting the right number of the right patients for any clinical trial can be a tough prospect. Now there are a host of new efforts to match a patient with a clinical trial, including a service offered by the for-profit company EmergingMed. Analysts note that only about a quarter of the 200,000 eligible U.S. patients diagnosed with cancer participate in clinical trials each year. And while there are a number of reasons cited, the primary cause appears to be simple ignorance about what's going on.

The Wall Street Journal notes that there are a number of new outreach efforts that are being launched, but one of the most intriguing is operated by EmergingMed, which helps coordinate a patient's search for the right trial.

"We need to explain to the American public that the drugs we are benefiting from today did not come out of thin air," says Armin Weinberg, director of Baylor College of Medicine's Chronic Disease Prevention and Control Research Center in Houston. "Their participation in trials is the thing that is going to help us advance in all these battles against cancer, asthma, diabetes and hypertension."

- check out this release on the matching service
- read the article from the Wall Street Journal

Pfizer builds plant, creates jobs in Ireland

Fri, 02 May 2008 06:59:58 -0400

Pfizer has finally confirmed earlier reports about its plan to build a biologics manufacturing facility in County Cork, Ireland. The company is investing €190 million ($297 million) in the new facility and anticipates creating 100 jobs. The plant will manufacture small amounts of biologic treatments for use in Phase II and III cancer and diabetes clinical trials. It will be situated next to Pfizer's other Cork facility and is expected to be completed in 2009.

"Our aim is to gain access to the best science inside and outside our walls, and the new Shanbally facility will ensure that we can produce the product for clinical trials which could ultimately impact the lives of millions of patients," said Nat Ricciardi of Pfizer Global Manufacturing.

Pfizer's investment is good news for Ireland. Late last year Amgen said it would "postpone indefinitely" a planned €800 million manufacturing facility in Cork, much to country's disappointment.

- here's the report for more

Roche expands Memory pact

Fri, 02 May 2008 06:59:55 -0400

Roche has exercised its option to further develop and commercialize Memory Pharmaceuticals' drug candidate, MEM 3454, for various neurological and psychiatric disorders. Memory gets a $6 million milestone payment and will be eligible for a $17 million once an ongoing Phase IIa study in cognitive impairment associated with schizophrenia (CIAS) is completed. Back in November, Memory Pharmaceuticals announced a positive Phase II proof-of-concept trial of MEM 3454 in 80 patients with Alzheimer's disease.

"We are excited that Roche shares our enthusiasm for MEM 3454 and its potential to address the cognitive deficits associated with debilitating CNS disorders," stated Vaughn M. Kailian, Memory's CEO. "We have aggressively advanced MEM 3454 through early-stage clinical trials, including a positive Phase IIa trial in Alzheimer's disease. We believe that Roche's continued commitment to the program, together with its expertise in later-stage clinical development and commercialization, will provide the support and capabilities to realize the full potential of this compound."

- check out this release

Resolvyx rounds up $25M

Tue, 22 Apr 2008 06:59:55 -0400

Bedford, MA-based Resolvyx has garnered $25 million in a second round of venture capital. QVT Financial LP led the funding round. The money will be used to accelerate Resolvyx's preclinical pipeline development and to advance multiple resolvin drug candidates into clinical trials in 2008. Resolvins are a recently discovered family of naturally-occurring, small molecule lipid mediators that resolve inflammation.

"We are excited about the growing recognition of the value of our unique resolvin platform. Attracting investors of this caliber underscores the significant progress we have made toward breakthrough drug products," said Paul Rubin, M.D., President and CEO of Resolvyx. "This funding allows us to continue to advance our resolvin therapeutic candidates, RvE1 and RX-10045, and to further evaluate additional resolvin and protectin compounds." Resolvyx's first round occurred in 2005, when the company gained $17 million.

- see this release for more

ALSO: Another Massachusetts-based company, Cambria Pharmaceuticals, has closed a $5.4 million Series A financing. Release

SPOTLIGHT: Angiotech suspends trial

Mon, 21 Apr 2008 06:59:53 -0400

Angiotech suspends trial
Angiotech is suspending clinical trials for its Vascular Wrap product candidate in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance of infections that have been observed between the two study groups. Release

Paratek funds Phase III launch with $40M in VC

Wed, 16 Apr 2008 06:59:55 -0400

Paratek Pharmaceuticals has closed the second tranche on its $40 million round of venture funding. The money allows the Boston-based developer to launch a Phase III trial of the experimental antibiotic PTK 0796. In a statement, the biotech says that it expects to release Phase II data at an appropriate forum later this year. Aisling Capital led the financing, with additional participation by new investors, the D.E. Shaw group and Boston Life Science Venture Corporation, and prior investors, Nomura Phase4 Ventures, Novartis BioVentures, BioFund Ventures, HBM BioVentures, Lombard Odier Darier Hentsch, BioVeda Fund and Hercules Technology Growth Capital.

"The second tranche of the financing was triggered by the successful completion and positive results of the Phase II clinical trials of oral and IV PTK 0796," says CEO Thomas Bigger. "The financing will be critical in advancing this program into Phase III, which we expect to initiate later this year."

- check out the press release

CellCyte in 'precarious' shape after shares collapse

Tue, 15 Apr 2008 06:59:57 -0400

After a brief period as a high-flying stem cell company, CellCyte Genetics' share price has fallen back to earth, wiping out much of the $440 million market valuation achieved last fall and leaving it in "precarious" financial shape. The Seattle Times is reporting that CellCyte has about five months worth of working capital on hand with shares trading at 45 cents each, down from a high of $10.01 hit last year after an intense period of stock promotion. The stem cell company now faces shareholder lawsuits and an investigation by German regulators of its stock promotion work. Documents filed with regulators on Monday say the company has raised $400,000 from investors since the end of the year. CellCyte had discussed plans of starting clinical trials of stem cell therapies this year at a cost of $7 million in 2008.

- read the report in the Seattle Times

Related Articles:
Report: CellCyte stock up after promoter touts shares. Cellcyte Report
Falling dollar, falling drugmaker prices. Stock report

PPD plots 300-person operation at NC Campus

Wed, 09 Apr 2008 06:59:54 -0400

California billionaire David Murdock (photo) scored an economic development coup with today's announcement by PPD that it will set up a 300-person operation in the North Carolina Research Campus in Kannapolis. PPD's Fred Eshelman (photo) says he was won over during a trip to the $1.5 billion complex being promoted by Murdock. PPD is one of the largest contract research organizations, conducting clinical trials for pharma and biotech developers.

"After meeting with Mr. Murdock and visiting the campus, I realized this project is a once-in-a-lifetime opportunity, where industry and academic scientists can freely collaborate to bring innovations in scientific research to market, increasing the length and quality of human life," Eshelman said Wednesday morning in an announcement.

- read the report in the Triangle Business Journal

Related Articles:
PPD inks deal to buy Russian CRO
PPD sells rights to inhibitors for $15M up front
North Carolina steps up biotech funding

SPOTLIGHT: Neurogen cuts jobs (again)

Wed, 09 Apr 2008 06:59:53 -0400

Facing a delay of clinical trials for its lead therapy, Neurogen slashed 45 more jobs and announced plans to focus its development programs. The developer also raised $30.6 million in a private placement with institutional investors. That money will be used to advance research for the company's four clinical programs in insomnia, anxiety, restless legs syndrome, and Parkinson's disease. Release

Vivus land $30M for Phase III work

Fri, 04 Apr 2008 07:59:56 -0400

Vivus has garnered a $30 million funding collaboration with Deerfield Management to advance work on the company's ED drug avanafil. Using $20 million from a Royalty and Funding Agreement and $10 million from the sale of Vivus common stock, Deerfield will finance a Phase III study of the drug. "The collaboration with Deerfield allows us to move avanafil into the phase 3 clinical trials on a timely basis. The funding collaboration provides us with financial flexibility and allows us to leverage the MUSE franchise for the benefit of avanafil development," stated Vivus' CEO Leland Wilson

- here's the press release for more

Related Articles:
Vivus get $140M milestone payment. Report
Vivus shares rise on Phase II ED data. Report

Study finds big gaps in clinical trial process

Thu, 03 Apr 2008 07:59:57 -0400

A new report out says that the clinical trial process routinely ignores women, the elderly, minorities, the disabled and people living in rural America. And the practice of ignoring large groups is creating a trial process that often avoids the very patients the drugs are intended to serve, according to the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine. The elderly, for example, are often excluded from trials that test new drugs for Alzheimer's, Parkinson's and other conditions that primarily afflict older people. Excluding minorities, meanwhile, skews the data in such a way that trials fail to discover how genetics and cultural factors can affect outcomes.

"We've got a big problem," said Daniel S. Goldberg, chief policy adviser for the report. "And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline healthcare and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

Altogether there are some 80,000 clinical trials mounted every year in the U.S. Many are duplications of other trials that have already been completed or are underway. And less than one percent of the population is recruited to participate.

- read the article in the Washington Post

Related Articles:
Researchers fight for ethnic diversity in trials. Report
Report: FDA lax in clinical trial oversight. Report
Safety oversight a rare feature in child drug trials. Report
Duke, FDA join forces to overhaul clinical trials. Report

SPOTLIGHT: Simulating the immune system

Thu, 03 Apr 2008 07:59:53 -0400

Time magazine profiles the work of VaxDesign, a five-year-old biotech company that has developed simulated human immune systems, mixing blood cells and faux tissue into a special construct that can test a vaccine--"clinical trials in a test tube." FierceVaccines

Lilly's prasrugel stands out in comparison study

Mon, 31 Mar 2008 07:59:57 -0400

Here's one other reason for Lilly to be upbeat today. In a head-to-head study, the new antiplatelet drug prasugrel (being developed by Lilly and Daiichi Sankyo) in combination with aspirin outperformed the standard therapy, clopidogrel (Plavix) with aspirin. Analyzing the data from 12,844 patients in clinical trials, researchers concluded that the prasugrel group suffered fewer ischemic events--including stent thrombosis--than the Plavix group. Patients who have been given a stent to open up the flow of blood are at risk of blood clots, or stent thrombosis. They're given doses of antiplatelet drugs to prevent the clots from occurring.

"These data highlight the importance of aggressive antiplatelet therapy to reduce ischemic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention," the study authors concluded. "When balancing risks and benefits of strategies to prevent ischemic events, consideration should be given to patient characteristics, including risk of bleeding and ischemic events as well as stent and procedural characteristics."

- check out the release
- read the story in the Washington Post

Relate Articles:
Investors fret over Lilly's pipeline, Prasugel data. Report
Doubters see big obstacles for Lilly's Prasrugel. Report
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Risk averse? Not us, says top FDA official

Wed, 26 Mar 2008 07:59:58 -0400

Is a rising tide of risk aversion at a post-Vioxx FDA behind the agency's anemic approval record? No way, say the FDA's Janet Woodcock (photo). It's all about the science. And the science, she insists, is pointing to troubling indicators about some of these new drugs.

"We have a different story from the companies," Woodcock told the Financial Times. "We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions."

The length and size of clinical trials are growing, Woodcock acknowledges, but that's because regulators know more about what they need by way of data. And new efforts to standardize trials--à la Henry Ford--should help matters. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it."

- check out the article in the Financial Times

Related Articles:
2007 FDA approvals. Report
More mixed messages from the FDA. Report
FDA: Hyper-cautious or simply vigilant? Report

India moves to back up emerging biotech industry

Mon, 24 Mar 2008 07:59:55 -0400

The Times of India lauds new efforts in the subcontinent to encourage the growth of its biotech industry. Under new legislation, the country's department of biotechnology is now setting aside 30 percent of its annual budget to fund public/private collaborations on new drug development. A new council has been created to help coordinate efforts between academics and biotech companies and a new regulatory body has been created. India has a shortage of trained regulators, but the Times editorial suggests that the FDA may step in to help train personnel.

- read the editorial in the Times of India

Related Articles:
India emerging as big drug market. Report
China surges past India in drug discovery work. Report
China now leads India in ongoing clinical trials. Report
Bangalore Bio: India's biotech future is bright. Report

Safety oversight a rare feature in child drug trials

Wed, 19 Mar 2008 07:59:56 -0400

Only one of every 50 drug trials involving children assembled an independent safety monitoring group to watch for signs of dangerous side effects, according to a sweeping review of 739 international trials mounted between 1996 and 2002. And the analysts said that among the tiny fraction of trials that utilized a monitoring group, six were stopped due to signs of toxicity. Adverse side effects were reported in 37 percent of all trials and about one in ten recorded side effects that were moderate to severe and occasionally life threatening.

"We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children," Dr. Helen Sammons, associate professor of child health at Nottingham University, told the Guardian.

Sammons went on to note that drug trials for children were still a relatively recent phenomenon. In the past, children were often given the same medicines as adults, with sometimes disastrous results. A child's metabolism is distinctly different from an adult's, raising the risk that they will experience unique adverse events.

- check out this release on the findings
- read the article in the Guardian

Related Articles:
Duke, FDA join forces to overhaul clinical trials. Report
Pediatric program helps spur new drug research. Report
Pilot program to monitor pediatric health. Report
FDA overhauls trial design with new suicide standard. Report