Companies Archives - Page 41 of 59

Anthera Pharmaceuticals Completes Interim B-Cell Analysis of PEARL-SC Study

HAYWARD, Calif., Dec. 1, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.

After analysis by an independent statistician, data from the on-going PEARL-SC study indicate that weekly and monthly subcutaneous doses of blisibimod resulted in statistically significant reductions of B-cells. Elevations in these B-cells have been associated with an increased risk of disease activity in lupus patients. These findings are consistent with data from previous clinical studies of blisibimod. The company remains blinded to primary efficacy data.

Anthera Pharmaceuticals - 12/01/2011

Anthera Pharmaceuticals Completes Interim B-Cell Analysis of PEARL-SC Study

HAYWARD, Calif., Dec. 1, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced positive interim biomarker data from the PEARL-SC phase 2b clinical study in patients with systemic lupus erythematosus.

"We believe reductions of B-cells in the PEARL-SC study will correlate to a reduction in disease activity in patients treated with blisibimod," said Colin Hislop, MD, Chief Medical Officer and Senior Vice President of Anthera Pharmaceuticals. "This analysis demonstrates that the selected weekly and monthly blisibimod doses resulted in an appropriate biological response. If confirmed with positive clinical outcomes from the PEARL-SC study, these data will provide guidance for the design of our phase 3 clinical studies and allow us to differentiate blisibimod from other available BAFF inhibitors for the treatment of lupus."

Final results from the PEARL-SC clinical study are expected in the second quarter of 2012. A proposed amendment to PEARL-SC also includes an option for an interim efficacy analysis to be conducted by an independent statistician after the 350th enrolled subject has reached 24 weeks in the study -- the primary efficacy time point.

About PEARL-SC
PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus (SLE). The clinical study enrolled five hundred and forty-seven (547) patients in 11 countries and 72 clinical sites worldwide. The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in a SLE responder index -- a composite responder index evaluating various patient and physician reported clinical disease activity including a SELENA/SLEDAI* improvement of five (5) points or greater, no increase in a physician's global assessment of more than 0.3 points, with no new BILAG A or two new BILAG B organ domain flares.

*SELENA-SLEDAI -- Safety of Estrogen in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative, weighted index of systemic lupus erythematosus disease activity

About B-Cell Activating Factor (BAFF) and blisibimod
BAFF has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.

About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has three late stage clinical products: varespladib methyl (A-002), A-001 and blisibimod (A-623). Varespladib methyl (A-002) and A-001 are designed to inhibit a novel enzyme target known as secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease. Blisibimod targets elevated levels of B-lymphocyte stimulator (BAFF) which have been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus) and rheumatoid arthritis.

Anthera Pharmaceuticals - 12/01/2011

More Big Foundations Are Investing in For-Profits

Major foundations are increasingly relying on program-related investing to achieve their goals, putting money into for-profit firms whose work meshes with the donors’ causes, according to The New York Times.

The Bill & Melinda Gates Foundation has increased its pool for such investments, known as PRI’s, from $400-million to $1-billion since 2009, and earlier this year it bought a $10-million stake in Liquidia Technologies, a commercial firm working on vaccine delivery. The Omidyar Network, the David & Lucile Packard Foundation, and other funding entities have also stepped up PRI’s.

Money invested in PRI’s can go toward the federal requirement that foundations pay out 5 percent of their assets every year.

Grant makers “are increasingly agnostic about how they achieve their goals,” Independent Sector CEO Diana Aviv said. “If their purpose is, say, to eliminate food deserts, they may see supporting a grocery store chain as the best way of doing that rather than funding a nonprofit program.”

But, she said, the trend could have dire consequences for charities addressing the same issues, which are already experiencing a “slow erosion of nonprofit funding streams that threatens to undermine organizations that have been built over decades to meet high standards of public trust.”

Liquidia Technologies - 11/29/2011

FierceBiotech's 2011 Women in Biotech - Plexxikon President and Tesaro Co-founder Honored

November 29, 2011

Female biotech executives have been key players in many of the biggest events in the industry this year--Takeda Pharmaceutical's buyout of Nycomed, the merger of Alkermes ($ALKS) and Elan Drug Technologies and the sale of Plexxikon to Daiichi Sankyo. Should we be surprised? No, women in this industry defy the odds when they rise to key positions in the male-dominated biotech game. Of course we're seeing them accomplish big things. But they deserve recognition.

So, we're excited to bring our readers FierceBiotech's much-awaited-and belated-Women in Biotech feature. We had an overwhelming response to our call for nominations this year, with more than 130 great submissions and an amazing slate of candidates. True to our mission of providing readers the top news in biotech, many of the honorees here are women who drove some of the big stories we covered this year. We also wanted the women featured this year to represent the best of the global biotech industry, and you'll find women here who are making an impact for organizations based in Asia, Europe and here in the U.S.These women are inspiring, not just to women, but (at least speaking for the males on our team) men involved in the industry, too. Our profiles will bring you up to date with what each of these female movers in biotech are working on these days. Some are rallying scientists at young startups, gearing up for important late-stage trials or leading research of serious health concerns such as HIV. For each of the honorees, there are unique stories about how impressive women have gotten ahead in the competitive biotech field."

I think that the potential interesting little extra that you get from speaking to some of the women in biotech is we've probably been challenged with thinking a little bit more about how to cultivate our careers," said Abbie Celniker, chief executive of Eleven Biotherapeutics and one of this year's Women in Biotech. "As a result, we can be a tiny bit more self-reflective because we've had to do lots of course correction to make sure we could compete in the days when it was more predominately male."

Kathleen Sereda Glaub
President, Plexxikon

In the biotech business and at her home garden, Kathy Glaub likes to plant seeds and watch them grow. Of course, the seeds of biotech involve investments in R&D and carefully crafted financing strategies. In those regards, there's been a bumper crop this year at the drug discovery firm Plexxikon, and Glaub has been able to savor the fruits of her 10 years spent helping to shape the business strategy and firming up lucrative partnership deals.

Mary Lynne Hedley
President, CSO, Co-founder, Tesaro

Mary Lynne Hedley's latest biotech adventure has her exploring multiple paths to find and develop new therapies and supportive care drugs for cancer patients. Hedley, the president and chief scientist at Lexington, MA-based Tesaro, is now leading the company's excursion to gain FDA approval of its lead compound, rolapitant, which aims to prevent nausea and vomiting from chemotherapy and is ready for late-stage trials. At the same time, she's responsible for hunting for other drugs for cancer patients that fit the company's in-licensing strategy.

Plexxikon / TESARO / Uncategorized - 11/29/2011

Achillion to Present at the 23rd Annual Piper Jaffray Health Care Conference

NEW HAVEN, Conn., Nov. 21, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that members of the Company's executive team will present at the upcoming 23rd Annual Piper Jaffray Health Care Conference on Wednesday, November 30, 2011 at 11:00 a.m. EST at The New York Palace Hotel, in New York, NY.

The live audio broadcasts and the subsequent archived webcasts of the Company's presentations will be available on the Company's website, http://www.achillion.com, under the "News Center" section. The audio recording will be archived for 30 days following the live presentation. Please connect to Achillion's website several minutes prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

Achillion Pharmaceuticals - 11/21/2011

CardioDx Passes Trial, Determining When Chest Pain Is No Big Deal

November 15, 2011

Chest pain is one of the big reasons people go to the ER or to see their primary care doc. Often when people get there, it’s hard to tell who has serious heart disease or something less serious. Now Palo Alto, CA-based CardioDx is presenting study results that say its new blood test, in certain situations, can help doctors tell the difference.

CardioDx said today that its test, called Corus CAD, was more effective than standard imaging techniques in a study of 537 patients. The study found that the gene expression test, which relies on a blood sample, was better than standard myocardial perfusion imaging (MPI) at ruling out the patients who don’t have coronary artery disease. The results, from a study called Compass, are being presented today at the American Heart Association’s scientific sessions in Orlando, FL.

CardioDx - 11/15/2011

CardioDx Passes Trial, Determining When Chest Pain Is No Big Deal

The company is hoping that studies like this one will help convince doctors to start sending in samples into its lab for a new kind of gene expression test, in hopes of avoiding other expensive and invasive procedures that end up being a waste. And there’s a huge amount of waste in cardiology that doctors, patients, and insurers would like to reduce. Of 400,000 people studied who underwent elective angiographic procedures, almost two-thirds (62 percent) were found to have no coronary artery blockage, according to a separate analysis published last year in the New England Journal of Medicine. The CardioDx test won’t be able to eliminate all the unnecessary procedures, but it should be able to reduce them significantly when used in combination with other diagnostic tools.

“We now have a blood test for coronary artery disease, which we never had before,” said Gregory Thomas, a professor of medicine at UC Irvine, who’s presenting the results today in Orlando. “It’s not perfect, but it can provide a very powerful opportunity for physicians to evaluate patients who may have heart disease.”

Gregory Thomas

CardioDx is backed by a cast of big name investors, who are betting that this test will work its way into mainstream medical diagnosis, and that insurers will figure it’s worth the $1,195 price tag. CardioDx raised $60 million last May, and has raised cash from the likes of J.P. Morgan, Kleiner Perkins Caufield & Byers, Mohr Davidow Ventures, TPG Biotech, Intel Capital, Pappas Ventures, and GE Capital, among others. At the time of the May investment, CardioDx said its test had been used for 13,000 patients, and a company spokeswoman now says that figure has grown to 20,000.

The potential market for a new coronary diagnostic like this is huge—an estimated 9.2 million people underwent the standard MPI tests in 2005, CardioDx says. Those tests typically cost about $800, and take about three hours to yield results, Thomas says.

Today’s test results, for sure, will go toward helping the company make its case for broader adoption. Patients in the study were considered stable, but had symptoms suggesting they might have coronary artery disease—a warning sign for future heart attack or stroke. They gave blood samples for the CardioDx test, which analyzed the extent to which RNA from 23 genes was active or inactive. The patients then got the usual myocardial perfusion imaging (MPI). Both of those readouts were compared later with the gold standard diagnostic findings from invasive angiography or CT angiography.

Researchers found that the new test was superior to MPI in what’s known as negative predictive value, which helps doctors rule out coronary artery disease. The CardioDx test was able to rule out coronary artery disease 96 percent of the time, compared with 88 percent of the time for MPI imaging. The difference was statistically significant.

The CardioDx test separated patients into two categories—those with high or low probability of having coronary artery disease. Researchers found that 46 percent of patients had a low score, and 54 percent had a high score. The results meant the most for patients who have the low score, because for them, it means that 96 percent of the time they be confident they don’t have coronary artery disease, says CardioDx chief medical officer Mark Monane.

Still, there’s a fair bit of uncertainty among those with a high score. CardioDx suggests that those with a high score go on to get a follow-up MPI test, Monane says. By layering those two tests on top of each other, doctors can hope to weed out many more patients who would otherwise get unnecessary invasive coronary procedures, he says. Even so, by adding in the CardioDx test, a majority of patients (53 percent) are still expected to get invasive procedures when they don’t have coronary blockages, Monane says.

The CardioDx test has its limits. It can’t be used in emergency situations, because it only provides an answer in a 72-hour turnaround time from the company’s Palo Alto lab. It’s an open question whether in the real world, physicians who get a low score will trust the data, and forgo further tests that add costs. And it isn’t for patients with diabetes, who already have higher coronary risks, Monane says.

But today’s findings could help CardioDx appeal to a broad group of primary care physicians and cardiologists who are looking for ways to better diagnose chest pain in a convenient way.

“We think our test is validated, it’s easy to use, it’s a blood draw, it can be done immediately, and it doesn’t require people to go out and buy an expensive piece of equipment,” Monane says.

Thomas, who is presenting the results today at the American Heart Association meeting, said there is a lot of interest among his peers in the data. But it will take time before people start actually incorporating it into their practice. He isn’t sure whether it will reduce healthcare costs, because some doctors may like the technology enough to use it on broader groups of patients than intended. Further in the future, the technology could also find additional uses, like as a monitoring tool in clinical trials to see whether drugs like cholesterol-lowering statins are working or not, he said.

“Physicians will want to see other physicians using it, and want to see it embedded in clinical guidelines,” Thomas says. “This doesn’t change medicine tomorrow, but it’s one step in potentially changing heart care.”

CardioDx - 11/15/2011

Epigenetic Therapy Shows Promise in Hard-to-treat Lung Cancer

November 9, 2011

PHILADELPHIA — Patients with recurrent metastatic non-small cell lung cancer have a morbid prognosis, but a new epigenetic therapy may have potential for this population, according to data published in Cancer Discovery, a journal of the American Association for Cancer Research.

A research team at Johns Hopkins University tested a combination epigenetic therapy of azacitidine and entinostat among 45 patients with recurrent metastatic non-small cell lung cancer who had been heavily pretreated with other therapies but showed no response. Each patient received azacitidine on nine days and entinostat on two days per month. The trial had an “open-label” design, in which all patients received the treatment and there was no control group receiving a placebo.

Syndax / Uncategorized - 11/09/2011

Anthera Pharmaceuticals, Inc. (ANTH) Announces Last Patient Enrolled in PEARL-SC Study

HAYWARD, Calif., Oct. 25, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has completed enrollment in the Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus (SLE). The targeted number of five hundred and forty (540) patients has been randomized in 11 countries and 72 clinical sites worldwide.

Anthera Pharmaceuticals - 10/26/2011

Anthera Pharmaceuticals, Inc. (ANTH) Announces Last Patient Enrolled in PEARL-SC Study

HAYWARD, Calif., Oct. 25, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has completed enrollment in the Phase 2b PEARL-SC study. PEARL-SC (A randomized, double-blind Phase 2b study to evaluate the efficacy, safety, and tolerability of blisibimod administration in subjects with systemic lupus erythematosus) is examining the therapeutic benefit of weekly and monthly subcutaneous injections of blisibimod in patients with active and antibody positive systemic lupus erythematosus (SLE). The targeted number of five hundred and forty (540) patients has been randomized in 11 countries and 72 clinical sites worldwide.

Also, as part of the Company's efforts to improve treatment options for patients with SLE, the Company submitted a protocol amendment to the FDA for the PEARL-SC clinical study that proposes a modification in the primary efficacy SLE response index to require a larger decrease in the SELENA-SLEDAI* clinical assessment score. The proposed primary endpoint will require patients to demonstrate a greater than or equal to five (>5) point reduction in the SELENA-SLEDAI, a well-recognized clinical assessment of lupus activity. The remainder of the responder index will remain unchanged with no new BILAG A or two new BILAG B organ domain flares, and less than a 0.3 (<0.3) increase on a three point scale in Physician's Global Assessment.

"As we move forward with the development of blisibimod, we are incorporating feedback from industry experts, physicians, and key opinion leaders regarding the potential for blisibimod to provide incremental benefits to patients with systemic lupus erythematosus compared to currently available therapies and other advanced stage clinical treatments," said Colin Hislop, MD, Senior Vice President and Chief Medical Officer. "Completion of enrollment in the PEARL-SC clinical study and the proposed change to the primary endpoint may allow us to accelerate our development efforts and further differentiate blisibimod from competing therapies."

The proposed amendment to PEARL-SC also includes an option for an interim efficacy analysis to be conducted by an independent statistician after the 350th enrolled subject has reached 24 weeks of treatment the primary efficacy time point. A successful interim analysis would require statistically significant improvement of the pre-defined SLE responder index of at least two pre-defined time points - one of which must be 24 weeks. The proposed interim efficacy analysis would be completed in Q1 2012 with the possibility of stopping the study early for efficacy using a pre-defined stopping rule.

The primary endpoint of the PEARL-SC study is clinical improvement at 24 weeks in the SLE responder index, a composite responder index evaluating various clinical patient and physician reported disease activity. Dr. Michelle Petri, Professor of Medicine at the Johns Hopkins University School of Medicine's Division of Rheumatology, and Dr. Richard A. Furie, Chief of the Division of Rheumatology and Allergy at North Shore-Long Island Jewish Health System, are the lead investigators of the study.

*SELENA-SLEDAI Safety of Estrogen in Lupus Erythematosus National Assessment / Systemic Lupus Erythematosus Activity Index is a cumulative, weighted index of systemic lupus erythematosus disease activity.

About B-Cell Activating Factor (BAFF) and blisibimod

BAFF has been associated with a wide range of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjogren's Syndrome, Graves' Disease and others. Multiple clinical studies with other BAFF antagonists recently have reported on BAFF's potential positive role in treating lupus and rheumatoid arthritis. Anthera is advancing its development of blisibimod, a broad inhibitor of BAFF, to expand its potential clinical utility in autoimmune diseases. Blisibimod is a novel fusion protein called a peptibody and is distinct from an antibody. Anthera owns worldwide rights to blisibimod in all potential indications.

About Anthera Pharmaceuticals

Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has three late stage clinical products: varespladib methyl (A-002), A-001 and blisibimod (A-623). Varespladib methyl (A-002) and A-001 are designed to inhibit a novel enzyme target known as secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease. Blisibimod targets elevated levels of B-lymphocyte stimulator (BAFF) which have been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus) and rheumatoid arthritis.

Anthera Pharmaceuticals - 10/26/2011