CeNeRx, expecting trial results and drug partner in 2012, raises $4.8M

CeNeRx, expecting trial results and drug partner in 2012, raises $4.8M

CeNeRx, expecting trial results and drug partner in 2012, raises $4.8M

Central nervous system drug development company CeNeRx BioPharma is developing an antidepressant whose novel mechanism causes fewer side effects, and the company is now in active talks with large pharmaceutical companies who could take the candidate, called TriRima, into phase 3 studies.

“We’re looking forward to (trial) results and a deal in 2012,” said CeNeRx CEO Barry Brand.

The Cary, North Carolina company has closed on a fundraise of $4.8 million that the company will apply to its portfolio of central nervous system drug candidates, chiefly TriRima, which is set to complete phase 2b trials early next year. Existing investors Perseus Soros Biopharmaceutical Fund, L Capital Partners, Pappas Ventures and Omega Funds all participated in the latest round. CeNeRx has raised more than $55 million to date.

TriRima is in a class of drugs called reversible inhibitors of monoamine oxidase, or RIMAs. The drug candidate works by blocking monoamine oxidase, an enzyme whose elevated levels are linked to depression. TriRima could be the first RIMA drug available in the United States.

CeNeRx is developing TriRima as a new drug for treatment-resistant depression. The current first line of antidepressants are selective serotonin reuptake inhibitors, or SSRIs, and serotonin-norepinephrine reuptake inhibitors, or SNRIs. But an estimated 30 percent to 50 percent of depression patients don’t respond to those drugs. Right now, the alternatives are atypical antipsychotics, which carry riskier side effects. TriRima would be a bridge between the safer first line of drugs and the more dangerous atypical antipsychotics, said Brand, a former GlaxoSmithKline (NYSE:GSK) executive who oversaw commercialization of several GSK antidepressants that include Paxil, Wellbutrin and Zyban.

TriRima is also safer in another regard. Because it has a different mechanism than a second major class of antidepressants called monoamine oxidase inhibitors, it does not lead to a potentially dangerous interaction with certain foods. MAO-Inhibitor antidepressants can affect the enzyme that metabolizes a compound called tyramine, found in fermented foods such as cheese and wine. That interaction, sometimes called a “cheese effect,” can cause a dangerous buildup of tyramine, which in turn increases cardiovascular risks.

There is considerable interest in developing novel antidepressants that comprise an estimated $20 billion market worldwide. But success in the field is far from assured. Winston-Salem, North Carolina-based Targacept (NASDAQ:TRGT) is in a high-profile partnership with AstraZeneca (NYSE:AZN) to develop TC-5214 for major depressive disorder. Targacept last month announced that the compound failed in the first of four phase 3 clinical trials for the compound.

CeNeRx’s compound appears promising, at least right now. The company is featured in the December report NeuroPerspective, published by NI Research. The report notes that RIMA drugs have shown a better side-effect profile in drugs that are now available in Europe.

“CeNeRx has put an exceptional amount of planning and care into the execution of the TriRima PhaseIIb, particularly in terms of monitoring patient enrollment and treatment compliance,” the report said. “While nothing is guaranteed in depression, this is a relatively high-likelihood-of-success trial.”

Before any partnership deals are struck, large pharmaceutical companies will be looking to see TriRima’s trial results. Many large pharmas have pared back their neurosciences operations. GSK in the last year has implemented cuts in neurosciences research as part of a review of its R&D efforts. Novartis (NYSE:NVS) recently announced it would close its neuroscience research facility in Switzerland. While Brand said he could not disclose which companies CeNeRx has spoken to, he said big pharma’s neuroscience R&D cuts mean that they’ll be looking to a small biotech such as CeNeRx to fill their pipeline.

Finding satisfaction in stratification

 

CAMBRIDGE, Mass., December 8, 2011 — Selventa, a personalized healthcare company focused on stratification of patients and development of predictive biomarker panels based on disease-driving mechanisms, recently formed a strategic scientific alliance with Linguamatics, a software solutions company that provides knowledge extraction through its I2E natural language processing (NLP) text-mining platform.

The idea is to combine the analytical capabilities of both companies to efficiently extract complex life science knowledge in a computable, structured, biological expression language format that can be used to interpret large-scale experimental data in the context of published literature.

Finding satisfaction in stratification

CAMBRIDGE, Mass.—Selventa, a personalized healthcare company focused on stratification of patients and development of predictive biomarker panels based on disease-driving mechanisms, recently formed a strategic scientific alliance with Linguamatics, a software solutions company that provides knowledge extraction through its I2E natural language processing (NLP) text-mining platform.

The idea is to combine the analytical capabilities of both companies to efficiently extract complex life science knowledge in a computable, structured, biological expression language format that can be used to interpret large-scale experimental data in the context of published literature.

That format is BEL, a structured language designed to represent scientific findings in a computable form with supporting contextual information, such as tissue, disease, species and publication. BEL is use-neutral, notes Dr. David Milward, chief technology officer at Linguamatics, and it articulates an idea in a manner that is “unambiguous, terse and conveys the facts and associated contexts without loss or ambiguity.” BEL, along with the BEL Framework, is available through a portal to the scientific community to promote the collection, sharing and interchange of structured scientific knowledge. Selventa's discovery platform operates on top of a scientific knowledge base made up of a set of BEL statements.

“The Selventa and Linguamatics collaboration shows how precise, detailed information can be automatically extracted from the literature and provided in a format suitable for further analysis and reasoning,” says Milward. “This will allow reuse of knowledge from the literature, at greater scale and speed.”   Much of the business and the future of Selventa are tied into biomarker discovery and personalized healthcare, David de Graaf, CEO of Selventa, tells ddn.

“The way we get there is having qualified knowledge available to us and to other users and comparing it to patient data sets. It’s a matter of pulling together prior knowledge in a usable manner with the analytics on top,” he says.

He notes that well-structured knowledge is already being customized within the scientific realm by organizations that are able to generate knowledge bases in specific areas, but in many cases they are using resources in China and India, “and we can’t directly compete with that,” he adds. “But well-quantified and organized knowledge is something our clients need and that drew us to Linguamatics so that this general knowledge out there could be put in a more terse and usable form.”

By using NLP-based capabilities to efficiently identify and extract relationships hidden in unstructured text and generate structured data for comprehensive biological investigation and analysis, the I2E platform is said to offer dramatically increased speed, scale and reproducibility, and the possibility to efficiently go back into a textual data source to pull out additional information that has become relevant.

“This partnership is a great strategic fit to facilitate the representation of complex biological knowledge that can be recycled and maximized through our analytical platform,” said de Graaf in the news release about the deal. “Collaborating with Linguamatics will enable rapid yet comprehensive investigation of new areas of biology by extracting computable knowledge from unstructured text. This will lead to innovation on many fronts, such as next-generation sequencing, where well-structured information for reasoning has been limited.”

One of primary goals for Selventa in this partnership is to be able to stratify patients using biomarkers.   “We’re doing a lot of this kind of work through the BEL initiative with Pfizer and along with Linguamatics as well, de Graaf says. He tells ddn that his company has also talked to other people in the knowledge space, whether publishers or other makers of knowledge bases, to get the best data possible.

“When customers acquire their data sets they often acquire broad assets that are shallow. They cover a lot of territory, like everything about clinical trials or a particular kind of chemistry, but what they don’t do is get what they often really need, which might be everything relevant in a particular area, like multiple sclerosis or breast cancer,” de Graaf says. “So you want to go relatively narrow but much deeper by integrating resources, and this is where Linguamatics helps us meet customers’ needs. We have a set of analytic tools that analyze prior experimental data and compare to your current set of experiments, and Linguamatics provides us with a platform for generating well-quantified knowledge from that.”

Having worked at companies like AstraZeneca and Boehringer Ingelheim, de Graaf had previously been involved in the evaluation and acquisition of NLP tools, and says that he came into Selventa already knowing folks at Linguamatics, “and far as I’m concerned, they are a premier provider of NLP solutions,” he says. “Unlike with other NLP platforms, where they are not expandable, Linguamatics meets our needs because its flexible—we knew our platform would require lots of tweaking, and knocking on their door to get technology that could handle that was just logical.”

Looking toward the future, de Graaf says he plans to work with the “best of the best” to implement not only a set of tools to feed into BEL but also to discover and analyze biomarkers, better stratify patients and more.

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 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.

"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.

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.”

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.

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.

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.