biomarkers

Battelle Ventures, Apax Partners spin off companies

Wed, 04 Jun 2008 06:59:54 -0400

There are two new spin-offs to announce today. First, Battelle Ventures has spun out regenerative medicine start-up NellOne Therapeutics from the U.S. Department of Energy's Oak Ridge National Laboratory. NellOne gets an initial investment of $1.5 million, which will be tranched based on key technical milestones.

Meanwhile, Sense Proteomic has been spun out as a biomarker discovery company; previously it was a subsidiary of Procognia, which makes bioscience tools. Apax Partners is backing the new company. Sense Proteomic will be using its protein array platform to discover panels of auto-antibody biomarkers in cancer and autoimmune diseases.

- see the release on NellOne
- here's the announcement on Sense Proteomic

Related Article:
Tips for funding a biotech start-up

FDA ready to start adding biomarker safety tests

Fri, 18 Apr 2008 06:59:56 -0400

The San Francisco Chronicle is reporting that the FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. The new standard would rely on seven biomarkers that indicate kidney injury. And the FDA wants to adopt a series of such biomarker tests that could flag heart damage, liver damage and cancerous side effects.

"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, tells the Chronicle. Woosley is working with the FDA to safely speed drug development.

For now, though, the FDA says it will only accept the new biomarker test in addition to the animal safety studies the researchers already rely on. So any savings that a developer can look forward to will have to follow a period of added costs.

- read the article in the San Francisco Chronicle

ALSO NOTED: Millipore CEO gains $3.9M comp package;Terminal cancer patients enlisted in trials; and much more...

Wed, 26 Mar 2008 07:59:50 -0400

> It may not rival the big bucks earned by Big Pharma CEOs, but Millipore chief exec Martin Madaus took home a hefty pay package last year. He earned $3.9 million in compensation in 2007. That includes $742,307 in base pay, a bonus of $488,000 and options worth $2.6 million on the day they were granted. Report

> Which drug exec gets paid 140 percent more than the median among his peers? Cephalon CEO Frank Baldino (photo). He made a cool $13.5 million last year. That paycheck included a $1.2 million salary, $2.2 million in bonus, and $10.1 million in stock and options. Report

> Mortality rates at 494 hospitals around the country that participated in clinical trials for acute coronary syndrome declined. Report

> Frustrated by the long years of research needed to prove the effectiveness of a new cancer therapy, British officials have designated a network of 19 hospital units that will be allowed to administer early-stage experimental cancer drugs to terminal patients. Report

> Big Pharma companies are often quick to turn their backs on a drug that doesn't deliver strong data. But a series of these failed development programs have been resurrected by scientists who decided to search for the kind of genetic biomarkers that would define a group of patients who would respond positively. Report

> Manipulating insulin levels raises the level of the master gene-regulating protein SKN-1, significantly prolonging the lives of microscopic worms in one study. Report

> HistoRx and Eli Lilly have extended their technology agreement. Story

> Pfizer and GlaxoSmithKline have been marking up meds to increase their revenues, according to Thomson data. The two companies boosted wholesale prices by about 9 percent on their 10 best-sellers last year. Without those increases, Pfizer and GSK would have seen their sales drop by more than 10 percent. Report

> Pfizer is suing for Lipitor protection until 2016. Report

And Finally... Many in the medical community are at odds over the ethics of at-home bipolar gene tests currently on the market. Report

Genizon pockets $31M CAD in fifth round

Mon, 07 Jan 2008 06:59:55 -0500

Canada's Genizon BioSciences has garnered $31 million Canadian in its fifth round of financing. The lead investor is BTF B.V. of Haarlem, The Netherlands, which specializes in late-stage biotech companies.

"Genizon's outstanding DNA resources and a platform that is applicable to many stages of drug development make a compelling investment case," said Jan Mellegers, CEO of BTF. "The company has impressed us with its ability to not only discover many genes in each disease, but also to assemble these into GeneMaps that lead to new drug targets and biomarkers."

- here's the release

ALSO: ZyGem says it has closed its first round of financing. Release

Related Article:
Pfizer inks genetic license with Genizon. Report

ALSO NOTED: Houston develop plots biotech park; Galvus wins EU nod; OncoMethylome inks deal with Abbott; and much more...

Mon, 17 Dec 2007 06:59:50 -0500

> A Houston developer has acquired Tanox's old headquarters--110,000 square feet on 24 acres--and plans to develop it as a biotechnology park. Tanox developed the asthma drug Xolair. Report

> European regulators are recommending approval of Novartis' Galvus. A diabetes drug. Novartis expects to launch the therapy in the first half of next year. Report

> Belgium's OncoMethylome Sciences has struck a deal with Abbott Laboratories to help profile tumors, testing its DNA methylation biomarkers on Abbott's biological samples. Release

> Chutes & Ladders: AlgoNomics has promoted Philippe Stas to CEO. Release

> Novartis and Merck are refocusing their sales efforts away from the doctors who write the prescriptions and toward the insurers that pay for them. Report

> One of Shire's shareholders is crying foul at the drug maker's big management reshuffling announced last week. Report

> Ex-FDA chief David Kessler got the boot at University of California-San Francisco, where he has been dean of the medical school since 2003. Report

> Bristol-Myers Squibb said it was going to retrench, and so it is. The company announced this morning that it would sell its medical imaging unit to the private equity firm Avista Capital Partners for about $525 million. Report

And Finally... A researcher is criticizing the way the U.S. is monitoring the spread of H5N1 in migratory birds, saying U.S. efforts could easily miss the virus as it makes its way into the country. Release

Biomarker company gains $25M in fresh backing

Mon, 15 Oct 2007 06:59:56 -0400

Rules-Based Medicine, which is hot in pursuit of new biomarkers, has received a $25 million injection of cash. Part of that money is coming from real estate billionaire Sam Zell, who is putting his son on the board. The money is being divvied up between future acquisitions, paying off for a recent buyout and funding a deal to buy out Luminex's interest in the company, which was founded using technology developed by Luminex. The Austin-based biotech company works for drug developers, providing biomarkers that can demonstrate how drugs work. Last week Rules-Based Medicine bought out a German company, Experimentelle und Diagnostische Immunologie, which offers a cell culture test that demonstrates how people react to medicines.

- see this release on the funding
- here's the report from the Austin American-Statesman

ALSO: Four-year-old Tengion has raised $33 million in its third round, adding to the $89 million it already has garnered from investors. The company is developing new ways to develop replacement organs and body tissue from patient's cells. Tengion was founded on the science of Dr. Anthony Atala at the Wake Forest Institute for Regenerative Medicine. Deerfield Partners led the round. Release

Related Article:
Tengion garners $50M in VC. Report

Read more on: Venture Capital

Wyeth drops Karo Bio atherosclerosis drug

Thu, 20 Sep 2007 06:59:55 -0400

Karo Bio and research partner Wyeth Pharmaceuticals have abandon development of LXR-623, a Phase I compound for atherosclerosis. According to a release, LXR-623 demonstrated efficacy on biomarkers for atherosclerosis but had an unfavorable profile for further development. However, the companies say they will continue their partnership on Liver X Receptor (LXR), with the aim to develop new treatments for atherosclerosis.

"Unfortunately, compounds do fail in the process but this is part of the development of pharmaceuticals. We remain optimistic about LXR as a target for treatment of atherosclerosis and for the prospects for new molecules for development. The learnings generated from the LXR-623 program will be valuable as additional potential compounds move forward," noted Per Olof Wallström, President of Karo Bio.

- see the release for more

Related Article:
Merck pulls out of Karo Bio collaboration. Report

ALSO NOTED: Indevus gains $50M payday; Genzyme settles suit; AnGes submits ERT; and much more...

Mon, 13 Aug 2007 06:59:50 -0400

> Indevus has snared a $49.9 million milestone payment following the FDA's approval of Sanctura XR. Release

> Genzyme has agreed to settle a shareholders suit for $64 million. Release

> Biomarin Pharmaceutical Japan-based partner AnGes MG has submitted enzyme replacement therapy Nagalzyme for approval to the Japanese Ministry of Health, Labour and Welfare, AnGes said. Release

> GeneNews has gained $2 million to develop prostate biomarkers. Release

> Ambit Biosciences has added 36 new kinases to its screening panel, including therapeutically relevant lipid, mutant, and atypical kinases. Release

> Australia has banned Novartis' Prexige. FiercePharma

> Just as predicted, Johnson & Johnson has found itself in the midst of a PR nightmare over its trademark dust-up with the American Red Cross. FiercePharma

And Finally... A bird flu outbreak has been reported on Bali. Report

Press Release: Adnexus Therapeutics Announces Presentation of Phase I Results for CT-322

Maureen Martino — Fri, 02 Feb 2007 12:54:00 -0500

Adnexus Therapeutics Announces Presentation of Interim Phase I Results for CT-322, First Adnectin Therapeutic in Humans

WALTHAM, Mass. -- Feb 2, 2007 - Adnexus(TM) Therapeutics, Inc. today announced interim results of an ongoing Phase 1 open-label, dose-escalation study of its novel anti-angiogenic biologic, CT-322, in patients with advanced cancers. These results were presented at the 9th International Symposium on Anti-Angiogenic Agents in San Diego, CA by Anthony W. Tolcher, M.D., FRCP of the Institute for Drug Development Cancer Therapy and Research Center in San Antonio, Texas. CT-322 is a proprietary Adnectin(TM) protein therapeutic that, in preclinical studies, specifically binds to vascular endothelial growth factor receptor 2 (VEGFR-2), which regulates the primary tumor angiogenesis pathway. As a result, CT-322 blocks all known ligands for VEGFR-2.

The phase 1 study was designed to assess the safety, tolerability, and pharmacokinetics of CT-322 in cancer patients, as well as to evaluate preliminary evidence of biological and antitumor activity. The maximum tolerated dose has not yet been reached.

CT-322 demonstrated promising evidence of biological activity in patients within four hours of drug administration as evidenced by elevated plasma levels of biomarkers of VEGFR-2 pathway, and these biomarkers remained elevated significantly above baseline throughout the multi-dose treatment period. In addition, CT-322 administration resulted in predictable, consistent pharmacokinetics that could support every-other-week dosing in humans.

"These initial results are very encouraging both for CT-322 as well as for the Adnectin class," commented Dr. Tolcher. "CT-322 has the potential to become an important cancer therapeutic due to its unique mechanism of action. More broadly, the emergence of a new category of drugs with such broad potential is rare and is very exciting for the clinical community."

"The first administration of an investigational Adnectin therapeutic to people, along with highly favorable and consistent drug properties that were observed in humans, propels our novel class of biologics ahead of other new targeted biologics paradigms such as siRNA, aptamers, nanobodies and other new antibody based approaches," commented John Mendlein, Ph.D., CEO of Adnexus Therapeutics. "Our preliminary human data for CT-322 support competitive drug-like qualities for the Adnectin class in many therapeutic areas. As a leader among companies developing new biologics, we believe medicines based on our Adnectin product class represent the next wave of vital medicines."

About CT-322

CT-322 specifically inhibits VEGFR-2 activation by its ligands VEGF-A, VEGF-C, and VEGF-D. In preclinical studies, this cell-surface receptor drives angiogenesis (growth of new blood vessels) in solid tumors, and CT-322 inhibits the tumorgenic effect of VEGFR-2 in preclinical models. CT-322 was designed using the PROfusion(TM) System, Adnexus' patented product design engine.

About the New Adnectin Product Class and the PROfusion System

Adnectins are an emerging protein therapeutic class that can be designed to treat a broad range of diseases. They are based on human fibronectin, an extracellular protein that is naturally abundant in human serum. The intrinsic properties of an Adnectin align with properties of successful drugs, including high potency, specificity, stability, favorable half life, favorable IP profile and high yield E. coli production.

Adnectins are designed using the PROfusion System, Adnexus' patented protein design engine, to achieve high potency and specificity for a therapeutic target while simultaneously selecting for ideal pharmaceutical product characteristics. PROfusion enables Adnexus to screen over 1 trillion unique Adnectins for each drug discovery program to "redirect" naturally occurring human fibronectin to act as a protein therapeutic. This greatly accelerates Adnectin drug discovery and development.

Adnexus is the exclusive developer of Adnectins. Adnexus solely owns the Adnectin patent estate that controls issued and pending patent properties to fundamental Adnectin forms. In addition, Adnexus exclusively controls its patented PROfusion protein design engine. Adnexus has over 100 issued and pending patent properties relating to Adnectins and PROfusion.

About Adnexus Therapeutics

Adnexus Therapeutics is focused on generating vital medicines through the discovery, development, and commercialization of its broadly applicable new therapeutic class, Adnectins. Adnexus' lead product candidate, CT-322, is in Phase 1 clinical development in oncology in the United States. The company also has a pipeline of other Adnectin products in preclinical research across multiple therapeutic areas. Adnectins are designed and optimized using PROfusion, the company's patented protein design engine that uniquely enables rapid optimization of protein therapeutics. The company is funded by four leading venture capital firms: Atlas Venture, Flagship Ventures, Polaris Venture Partners, and Venrock Associates.

This news release contains certain forward-looking statements that involve risks and uncertainties. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the timing of clinical trials, the risk that products that appeared promising in early research and clinical trials do not demonstrate safety or efficacy in clinical trials and the risk that the company will not obtain approval to market its products.

Adnectin(TM), Adnexus(TM) Therapeutics and PROfusion(TM) are trademarks of Adnexus(TM) Therapeutics, Inc. Adnexus(SM) Therapeutics is a service mark of Adnexus(TM) Therapeutics. For more information, please visit www.adnexustx.com

ALSO NOTED: Feds ask Genentech for more merger info; Japan confirms bird flu outbreak; and much more...

Sun, 28 Jan 2007 19:01:30 -0500

> The FTC has asked for more information about Genentech's proposed merger with Tanox. Report

> Japan has confirmed the third outbreak of avian flu in poultry. Report

> The head of ArQule's scientific advisory board will become the CEO of the newly-established Boston Biomedical. BBI will conduct scientific research under an eight-month contract with ArQule that will include a number of in vivo and in vitro studies, reports and publications related to mechanisms of action and biomarkers for ArQule's lead products, which are in human clinical trials. Release

> OncoGenex has priced its IPO of 4.5 million shares at $10 to $12 each. Report

> The FDA has approved Berlex's YAZ to treat moderate acne in women who want to use an oral contraceptive for birth control. Release

> Beijing Med-Pharm has acquired a stake in Guangzhou Pharmaceuticals, China's third-largest drug wholesaler. Release

And Finally… Researchers say that hard work and simple living have made one small town in Italy one of the healthiest places on the planet. Report

ALSO NOTED: Xoma, Schering-Plough extend collaboration; Sirion licenses gel; and much more...

Tue, 16 Jan 2007 19:01:30 -0500

> Xoma and Schering-Plough have extended their collaboration to develop antibodies for cancer and immune diseases. Release

> Sirion Therapeutics has licensed the U.S. marketing rights to Labatoires Thea's topical ophthalmic gel for eye infections. Report

> Molecular Insight Pharmaceuticals has entered into a worldwide, exclusive licensing agreement with Bayer Schering Pharma to acquire ZK-BA, a compound in development for the treatment of malignant melanoma. Release

> Cepheid and bioMerieux are teaming up to develop tests that identify biomarkers for antibiotic resistance as well as bacteria and fungi. Report

> BG Medicine is collaborating with Applied Biosystems in the discovery and development of biomarkers. BG brings its expertise in biology while Applied Systems contributes the instruments and software. Report

> Wellbutrin XR has been approved for marketing in The Netherlands, the first European approval for the drug. Report

And Finally… Fewer smokers, earlier detection and better therapies are listed as the three primary reasons for a decline in the number of cancer deaths in the U.S. In 2004 the number of cancer deaths dropped by 3,014 after dropping a few hundred the year before. This is the first time since 1930 that cancer deaths have declined. Article

The research keeps getting better

Thu, 21 Dec 2006 19:01:35 -0500

In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.

Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.

Press Release: French Agency for Industrial Innovation Grants EUR 25 Million to Transgene

Maureen Martino — Sun, 26 Nov 2006 12:45:49 -0500

French Agency for Industrial Innovation Grants EUR 25 Million to Transgene

STRASBOURG, France, November 24 /PRNewswire/ -- Transgene S.A. (Eurolist Paris: FR0005175080) announces today that it has been granted EUR 25 million by the French Agency for Industrial Innovation (Agence Francaise de l'Innovation Industrielle - AII) for funding Transgene's participation in the ADNA ("Advanced Diagnostics and New therapeutic Approaches") project. The funding, which is subject to a European Commission approval expected in the second quarter of 2007, is to be paid over the life of the project and will consist of grants for Transgene totalling EUR 17.8 million and loans of EUR 7.2 million refundable only in case of success.

The ADNA project aims at meeting the challenges of personalized medicine in the fields of cancer, infectious diseases and rare genetic diseases through the development of new diagnostic and therapeutic approaches. The ADNA project will be carried out by four partners: bioMerieux, Genethon, GenoSafe and Transgene, under the coordination of Merieux Alliance.

The core of the programme will be to develop pharmacogenomic approaches, i.e. identifying, developing and validating molecular markers (biomarkers) that would allow the prescription of new treatments to those patients most likely to benefit from them. Indeed, biomarkers aim at earlier diagnosis, better knowledge and follow-up of the disease evolution and the patient's response to the treatment.

"The funding will help Transgene expand and accelerate its therapeutic vaccines portfolio," said Philippe Archinard, Chief Executive of Transgene. "AII's decision to support the ADNA project with substantial funding is a recognition of its scientific, medical and industrial relevance."

About Transgene and Merieux Alliance:

Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials and one compound in Phase I studies. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. For further information about Transgene, please visit www.transgene.fr

Merieux Alliance is a privately-held French-based company whose mission is to fight disease, particularly infectious diseases by developing innovative and complementary tools spanning the complete range of healthcare: prevention, diagnosis, prognosis, therapeutic care and clinical follow-up. Merieux Alliance owns controlling interests in Transgene, bioMerieux, Silliker, ABL Inc. and Shantha Biotechnics Ltd.

Cautionary note regarding forward-looking statements:

This press release contains forward-looking statements referring to the Company's anticipated receipt of funding for, and participation in, the ADNA research project, as well as the eventual impact of Transgene's participation on the development of its therapeutic vaccines portfolio. However, the funding is subject to the approval of the European Commission, and there is no guaranty that the funding will be received. In addition, product development depends on a variety of factors, including the uncertainties inherent in biological and medical research and clinical testing. There is no certainty that the research will lead to products that achieve adequate therapeutic efficacy or regulatory approval. For further information on the risks and uncertainties involved in the development of Transgene's product candidates, see Transgene's Document de reference on file with the French Autorite des Marches Financiers and available on its website at http://www.amf-france.org and Transgene's website http://www.transgene.fr.

Press Release: Human Genome Sciences Announces Positive Phase 2 Results

Maureen Martino — Mon, 13 Nov 2006 12:36:50 -0500

Human Genome Sciences Announces Positive 76-Week Resuplts of Phase 2 Clinical Trial of Lymphostat-B in Systemic Lupus Erythematosus

- LymphoStat-B™ reduces signs and symptoms of SLE disease and demonstrates durable biological activity at 76 weeks -

- Phase 3 clinical trials to begin before year-end 2006 -

ROCKVILLE, Maryland – November 14, 2006 – Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that the 76-week results of a Phase 2 clinical trial demonstrated that LymphoStat-B™ (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus (SLE), exhibited durable biological activity, and appeared safe and well tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase 3 trials of LymphoStat-B™ increased from 46% at Week 52 to 56% at Week 76, with no increase in infections or infectious events observed over time.

The results were presented today in two oral presentations in Washington , DC at the 70th Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP). Additional LymphoStat-B results were reported in poster presentations throughout the meeting.

“The data that have emerged from the 24-week extension of the Phase 2 trial of LymphoStat-B show continued improvement beyond the first 52 weeks of treatment,” said Daniel J. Wallace, M.D., Clinical Professor of Medicine, David Geffen School of Medicine, UCLA (based at Cedars-Sinai Medical Center , Los Angeles ). “ The reductions we see in SLE biomarkers, as well as the improvements observed in health-related quality of life, appear to correlate with therapeutic response. In serologically active patients, LymphoStat-B significantly r educed SLE disease activity, as evidenced by changes in multiple biomarkers and clinical indicators, including the combined response rate chosen as the primary efficacy endpoint of the Phase 3 trials. We look forward to continuing its evaluation as a potential treatment for SLE.”

“The results presented at this year’s ACR/ARHP meeting confirm and extend the growing body of evidence that LymphoStat-B has the potential to help meet the significant unmet need that we see in the SLE patient population,” said William W. Freimuth, M.D., Ph.D., Vice President, Clinical Research – Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences. “We are encouraged that 96% of the patients who completed the 52-week Phase 2 study chose to participate in the 24-week extension phase. Many of these patients were first randomized into the trial as long as three years ago and continue on treatment today. This provides us with a substantial longitudinal safety data base as we prepare to initiate Phase 3 trials before the end of 2006.”

About the Phase 2 Trial Results

The Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose-ranging superiority trial to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. Serologically active patients accounted for 72% (323/449) of the total Phase 2 study population. 86% (386/449) of the patients were receiving background prednisone therapy, either alone or in combination. At Week 52, patients were offered the opportunity to participate in an optional 24-week extension phase. In the extension phase, all placebo patients received LymphoStat-B at a dose of 10 mg/kg, while patients in the LymphoStat-B 10 mg/kg treatment arm continued on the 10 mg/kg dose, and patients in the 1 mg/kg and 4 mg/kg LymphoStat-B treatment arms were offered the choice of continuing on the same dose or receiving LymphoStat-B at a dose of 10 mg/kg.

Of the patients who completed 52 weeks of treatment, 96% (351/364) elected to enter the 24-week extension phase of the trial, and 92% (321/351) of those who entered completed it. Of those completing the extension phase, 83% (265/321) continue to receive LymphoStat-B. The study began in October 2003.

In June 2006, HGS reported the full presentation of 52-week data from the Phase 2 trial of LymphoStat-B in patients with SLE. The 52-week results demonstrated that LymphoStat-B significantly reduced disease activity in patients with serologically active SLE, exhibited clinically relevant biological activity, and appeared safe and well tolerated. Among the Phase 2 study findings was a significantly improved response rate among serologically active patients at Week 52, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no BILAG worsening, and no worsening in Physician’s Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). This combination of measures is the primary efficacy endpoint in the Phase 3 program design.

The data presented at the ACR/ARHP annual meeting demonstrated that LymphoStat-B continued to reduce the signs and symptoms of SLE disease activity throughout the 24-week extension phase of the study, demonstrated durable biological activity at Week 76, and appeared safe and well tolerated, with frequency and severity of adverse events similar to placebo and with no increase at higher doses. The evidence of continuing improvement from Week 52 to Week 76 includes:

An increase from 46% to 56% in the response rate among serologically active patients, as d efined by an improvement in SELENA SLEDAI score of 4 points or greater, no worsening in Physician’s Global Assessment (with worsening defined as an increase in PGA of more than 0.30 points), no new BILAG A organ domain score and no more than 1 new BILAG B organ domain score from baseline. This combination of measures at 52 weeks is the primary efficacy endpoint of the Phase 3 trials.
An increase from 29% to 38% in the reduction in SLE disease activity among serologically active patients, as measured by SELENA SLEDAI.
An increase from 33% to 41% among serologically active patients who showed no worsening in the Physician’s Global Assessment.
An increase in the mean improvement in health-related quality of life from 3.0 points to 3.4 points among serologically active patients, as measured by the SF-36 Physical Component Summary score.
A durable reduction in anti-dsDNA autoantibodies (at least 50% or negative) among patients who were positive for anti-dsDNA at baseline (27% at Week 52; 28% at Week 76).
Durable or increased reductions from Week 52 to Week 76 in B-cell subsets including total CD20+, naïve (CD20+/CD27-), activated (CD20+/CD69+), and plasmacytoid (CD20+/CD138+).
An increase in C4 complement among patients with low C4 complement at baseline (33% at Week 52; 46% at Week 76).
Stable reductions in immunoglobulins, with no increase in infections or infectious events over time.
In addition, the 52-Week data showed that, in serologically active SLE patients, LymphoStat-B:

Significantly delayed the time to SLE flare after six months (p<0.04);
Reduced the frequency of SLE flares after six months;
Significantly reduced the frequency of patients transitioning from low-dose prednisone ( <7.5 mg/day) to high-dose prednisone (>7.5 mg/day) (p<0.05 over multiple time-points);
Significantly reduced the number of patients experiencing BILAG Neurological and Musculoskeletal organ domain flares at Week 52 (Neurological p=0.04; Musculoskeletal p<0.01; and Cardiovascular-Respiratory (p=0.06); and
Produced significant and clinically meaningful improvements in health-related quality of life in serologically active SLE patients.
The 76-week results of the LymphoStat-B Phase 2 trial, as well as the results of other studies presented at the ACR/ARHP meeting, demonstrated that therapeutic responses in patients with active SLE, as measured by the combined response index selected as the primary efficacy endpoint of the LymphoStat-B Phase 3 trials, correlated well with changes in SLE biomarkers and improvements observed in health-related quality of life. In the Phase 2 study, relative to baseline, responders across all groups (LymphoStat-B and placebo) exhibited greater changes in biomarkers for SLE disease and reported more improvement in health-related quality of life than was observed in non-responders.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the LymphoStat-B Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.

About LymphoStat-B

LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS™. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection. In lupus, rheumatoid arthritis, and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrated that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.

LymphoStat-B is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. It has received a Fast Track Product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA’s Continuous Marketing Application Pilot 2 Program.

For links to scientific presentations and posters referenced, or for more information about LymphoStat-B, visit www.hgsi.com/products/LSB.html.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease. The Lupus Foundation of America estimates that approximately 1.5 million Americans suffer from various forms of lupus, including SLE. More than 300,000 people are afflicted with SLE in the United States alone. Lupus can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. About 90 percent of the individuals diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov.

About Human Genome Sciences

The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.

The HGS clinical development pipeline includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company’s primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon™ for hepatitis C, and LymphoStat-B™ for lupus. Both compounds are expected to advance to Phase 3 clinical trials in 2006.

In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax™ for the treatment of anthrax disease. Other HGS compounds in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.

For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals or patients interested in inquiring about LymphoStat-B clinical trials or any other study involving HGS products in development are encouraged to inquire via the Contact Us section of the company’s web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.

HGS, Human Genome Sciences, ABthrax, Albuferon, BLyS and LymphoStat-B are trademarks of Human Genome Sciences, Inc.

SAFE HARBOR STATEMENT

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

PRA International acquires Dutch CRO

Sun, 18 Jun 2006 20:01:39 -0400

The fast-growing clinical research organization PRA International is gobbling up the Netherlands' Pharma Bio-Research for close to $107 million. Pharma Bio-Research has a 140-bed capacity in two locations for Phase I/IIa clinical trials. PRA has an existing Phase I facility in Lenexa, KS.

"The Pharma-Bio Research transaction provides us with a solid lab platform, augments our bioanalytic capability with the addition of biomarkers, bolsters our already strong European presence and complements our existing client base," said Pat Donnelly, president and CEO of PRA International. "Furthermore, we are gaining a talented, experienced team that is driven by quality and science. We welcome PBR's more than 300 committed and enthusiastic employees."

- here's the release on PRA

Phase II failure for CombinatoRx therapy

Tue, 06 Jun 2006 20:01:35 -0400

CombinatoRx of Cambridge, MA announced that a Phase II trial of CRx-150 failed to meet its primary endpoint as a therapy for periodontitis. The mid-stage trial did not demonstrate a reduction in a key indicator of inflammation among patients suffering from the bacterial gum disease. Looking for signs that the therapy reduced inflammatory biomarkers in patients, researchers failed to see an improvement in C-reactive protein after 42 days of treatment. The trial did hit a secondary endpoint in reducing CRP during the acute inflammatory stage of the disease. CombinatoRx plans further trials to better understand how the therapy works.

- here's the release on the trial data

ALSO NOTED: NPS shares sink on FDA news; OncoGenex touts Phase I data; and much more...

Tue, 02 May 2006 20:00:50 -0400

> Investors turned thumbs down on shares of NPS Pharmaceuticals after the company reported that the FDA suggested a new clinical trial for PREOS, its therapy for post-menopausal, osteoporotic women. NPS believes it can use existing data to gain FDA approval. Report

> Canada's OncoGenex is touting results from a Phase I study of OGX-011 for cancer. Report

> Bioniche Life Sciences has sold Cystistat for bladder disorder to an Irish company for $10 million. Report

> Akorn of Buffalo Grove, IL has signed a deal with Italy's Fidia Farmaceutici to develop four ANDA products. Release

> Atrium Biotechnologies is buying personal care products maker Amisol for $6 million. Report

> PPD has struck a deal to develop biomarkers for PDL BioPharma. Report

And Finally… About 40,000 AIDS patients are turning to "salvage therapies" as their bodies begin to lose their responsiveness to standard treatments. Article (WSJ sub. req.)

ALSO NOTED: Astellas denies $8.6B loan; Genizon closes tranche; and much more...

Tue, 28 Mar 2006 19:00:50 -0500

> Japan's Astellas Pharma is denying media reports that it is taking out an $8.6 billion loan for acquisitions. Report

> Genizon BioSciences has closed a first tranche of $12.4 million in convertible debentures. Release

> RenaMed Biologics is moving its corporate headquarters from Lincoln, RI to Westborough, MA this summer as it relocates close to Genzyme, its manufacturing partner. Report

> United Therapeutics plans to invest about $55 million in a new facility at Research Triangle Park, hiring some 160 workers. Report

> The FDA has approved Aurobindo Pharma' Zidovudine capsules for AIDS. Release

> Shares of Nanogen jumped on the FDA's approval of its congestive heart failure plasma test. Report

> GlaxoSmithKline has agreed to pay $14 million to state Medicaid programs to settle claims it blocked a generic competitor to Paxil. Report

> The FDA has approved the use of Relenza for the prevention flu in adults and children 5 years of age and older. Release

> A study of GSK's Advair found an encouraging trend line but failed to achieve statistical significance in reducing mortality rates. Report

> Caprion Pharmaceuticals's Applied BioMedicine group announced a research collaboration with Vertex Pharmaceuticals for discovering new biomarkers. Release

And Finally... Chinese researchers have shown that antibodies from horses vaccinated for H5N1 proved effective in protecting mice from the virus. Article

SPOTLIGHT: Agencies to ID biomarkers

Tue, 14 Feb 2006 19:01:33 -0500

The FDA, the National Cancer Institute and Medicare have announced a new joint initiative to find biomarkers for cancer. The research is intended to find which patients are likely to benefit from cancer therapies. Article

Compugen lays off staffers, restructures

Sun, 04 Dec 2005 19:01:39 -0500

Israel's Compugen is restructuring around three business units and laying off a quarter of its work force. In a drive to focus on short- and mid-term business goals, the drug discovery company has created three units: therapeutics, diagnostic biomarkers, and a research and discovery arm.

"It is now both possible and appropriate for the company to target the unique discovery capability that has been created to specific product areas and, while continuing to invest substantially in the further enhancement of our core research, to also focus these activities in broad, but clearly defined, application areas," said company CEO Alex Kotzer. "Unfortunately, this results in a number of very talented and loyal contributors to our past efforts and accomplishments leaving the company, which is a very painful step for us to take."

- read this report from Globes for more