B I O T E C H ’ S M O S T R E S P E C T E D N E W S S O U R C E F O R 2 0 Y E A R S
Arena Defends New Phase III
Pfizer Seeks New Indications
Data, Plans Lorcaserin Path
Using Biovista Bioinformatics
Arena Pharmaceuticals Inc. released data from its Phase A research collaboration between Pfi zer Inc. and III BLOOM-DM trial of weight loss drug lorcaserin in obese Biovista Inc. will seek new indications for Pfi zer drug and overweight diabetics on Tuesday, sparking plenty of candidates in development using a bioinformatics debate among analysts and investors about whether the technology platform developed by Biovista. Terms of new fi ndings would help – or hurt – the company’s chances the agreement include identifi cation of up to three at addressing issues raised in an FDA complete response new indications for each drug. Biovista will receive an undisclosed up-front payment and success milestone On the effi cacy front, the FDA wants obesity drugs to show either 5 percent placebo-adjusted weight loss or twice “Pfi zer enjoys a signifi cant leadership in the as many patients losing 5 percent of their weight on drug pharmaceutical industry in terms of wishing to vs. placebo. Lorcaserin has come under fi re for consistently systematically explore new uses of its drugs,” Aris Persidis, achieving the latter but not the former, and the new data president of Biovista, told BioWorld Today.
Pfi zer, of New York, established its Indications In its fi rst two Phase III trials, BLOOM and BLOSSOM, Discovery Unit in 2007 to reposition failed compounds lorcaserin delivered placebo-adjusted weight loss of 3.6 and identify additional indications for compounds in Gates: Vaccine Innovation,
Chemotherapy Can Contribute Delivery Key to Global Health
to Resistance to Itself
WASHINGTON – While the development of new drugs Beating cancer is a frequent occurrence – but often, only in general has experienced little progress over the past for a time. Drugs that work initially stop being effective, decade, innovation in vaccines and specifi c treatments, which all too frequently means that remission comes to a like HIV/AIDS therapies, has had a “great period of productivity,” said Microsoft Corp. founder Bill Gates, co- Research published this week showed that in some cases, chair of the Bill & Melinda Gates Foundation.
jamming a specifi c DNA repair mechanism may prevent He noted that the number of children dying cancer cells from developing resistance to chemotherapy. worldwide by age 5 has dramatically dropped from 20 Inhibiting so-called translesional DNA repair may provide a million per year in the 1960s to 8.5 million currently useful addition to some frontline chemotherapies.
– largely due to better vaccines and greater global Why cancer cells become resistant to chemotherapy drugs is still not fully understood. One idea is that “Smallpox has gone from killing 2 million per year chemotherapy selects for cells that are intrinsically to zero per year, and measles has gone from 1 .5 million resistant: First-round chemotherapy will kill the 99 percent deaths to 300,000” per year worldwide, Gates said of cells that are sensitive to it, allowing a patient to go home Tuesday at the 2010 mHealth Summit, which brought ACR ROUNDUP: CHEMOCENTRYX, HORIZON, IDERA .2 INSIDE: CLINIC ROUNDUP: AMGEN, ARDEA BIOSCIENCES, ARGOS THERAPEUTICS .3
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Coming Thursday in
The following data were presented at the American BioWorld Perspectives:
College of Rheumatology meeting in Atlanta. (Also see page 4.) • ChemoCentryx Inc., of Mountain View, Calif., said positive Phase I data for CCX354, an oral, small molecule designed to target the chemokine receptor CCR1 , showed an What and where are the hot jobs in the life sciences excellent safety profi le in healthy volunteers, as well as in during the next decade? And will there be enough rheumatoid arthritis patients. Pharmacokinetic data showed trained applicants to fi ll these positions? . . . Tune in to once-daily doses of CCX354 produced greater than 90 percent this week’s BioWorld Perspectives in which Contributing receptor coverage on blood leukocytes throughout the day. Writer Ilene Schneider discusses the top fi elds in life • Horizon Pharma Inc., of Northbrook, Ill., said results sciences and what it will take to get students interested from a long-term safety study of HZT-501, a single-tablet formulation of ibuprofen and high-dose famotidine, showed BioWorld Perspectives is a weekly e-zine that that the drug’s safety was comparable to ibuprofen alone. offers unique viewpoints on developments within Data also showed that HZT-501 was associated with a two- the biotechnology industry. And the best part is, it’s fold reduction in the incidence of dyspepsia compared to completely free. Opt-in at
ibuprofen alone, although not statistically signifi cant due to small sample size. The fi rm also presented data from its two pivotal studies of Lodotra, a modifi ed-release formulation of prednisone, showing that a statistically signifi cant and clinically relevant higher response rate evaluated by ACR Stock Movers
response criteria in rheumatoid arthritis (RA) patients treated with 5 mg of Lodotra compared to placebo, in addition to standard RA therapy, after 12 weeks of treatment. • Idera Pharmaceuticals Inc., of Cambridge, Mass., reported preclinical data showing that its IMO-3100, a Toll- like receptor antagonist, suppressed immune responses mediated through TLR7 and TLR9, reducing the production of cytokines such as tumor necrosis factor-alpha, interleukin-6, IP-10 and interferon-alpha in cells isolated from blood samples. TLR7- and TLR9-mediated immune responses remained suppressed by weekly IMO-3100 administration throughout the four-week treatment period. Data from another preclinical study showed that blood cells from healthy females produced higher levels of pro-infl ammatory (Biotechs showing signifi cant stock changes Tuesday) cytokines in response to TLR7 stimulation than do blood cells from healthy male subjects.
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and placebo groups in the BLOOM and BLOSSOM trials. Any valvulopathy signal is likely to spook investors because percent and 3. 1 percent, respectively. In the BLOOM-DM trial, lorcaserin is a 5-HT2C agonist specifi cally designed to avoid lorcaserin patients achieved 4.5 percent mean weight loss the valvulopathy issues of 5-HT2B agonists like Wyeth’s compared to 1 .5 percent for placebo, resulting in placebo- infamous Fen-Phen (dexfenfl uramine/phentermine).
The Fen-Phen ghost spooked a few of the FDA’s reviewers, In BLOOM and BLOSSOM, 47.5 percent and 47.2 percent too, but the agency didn’t raise the issue in its briefi ng of lorcaserin patients lost more than 5 percent of their documents or complete response letter, so Yoo said it is weight, approximately double the 20.3 percent and 25 “unlikely to become an issue” now. Lief added that BLOOM- percent for placebo patients, respectively. And in the new DM was a much smaller trial than the other two, and “a couple BLOOM-DM study, 37.5 percent of lorcaserin patients lost of patients can move the percentages in a large amount.” more than 5 percent of their weight, compared to 16. 1 Yoo and other analysts remained focused on the preliminary safety issue raised by both the FDA and its Technically, companies need to satisfy only one – not advisors: preclinical cancer signals in rats. Arena has always both – of the FDA’s effi cacy requirements, which Arena has maintained that the rat data have no relevance to humans, done. But FDA briefi ng documents ahead of a recent advisory and Lief said no cancer signal has been detected in any of committee meeting said the effi cacy criteria were met only lorcaserin’s clinical trials, including BLOOM-DM. But the by a “slim margin,” and the FDA reiterated its opinion that company will have to convince the FDA.
lorcaserin’s effi cacy is “marginal” in its complete response Arena and partner Eisai Inc. have a meeting with the letter. (See BioWorld Today, Sept. 15, 2010, Sept. 17, 2010, and FDA scheduled to discuss the complete response letter Leerink Swann analyst Steve Yoo wrote in a research Shares of San Diego-based Arena (NASDAQ:ARNA) fell 5 note that the BLOOM-DM data “may do little to alter that cents to close at $1 .48 Tuesday. The company reported that it had $176.5 million in cash as of Sept. 30, after posting a Yet Arena President and CEO Jack Lief disagreed. “We net loss of $36.3 million for the third quarter.
believe these results address the weight management Vivus Inc. also received an FDA complete response challenges of patients with diabetes,” he told BioWorld letter for obesity drug Qnexa (phentermine/topiramate) last Today, adding that diabetics typically have a hard time month. Orexigen Therapeutics Inc.’s obesity drug Contrave losing weight, so the fact that lorcaserin’s effi cacy in these (naltrexone SR/bupropion SR) will face the FDA’s panel next patients was fairly in line with its effi cacy in nondiabetics month. (See BioWorld Today, Nov. 1 , 2010.) ■ is “really good.” Lief also pointed to data showing that lorcaserin reduced HbA1c levels by 0.9 percent compared to 0.4 percent for placebo (p < 0.0001), with half of the lorcaserin Clinic Roundup
patients getting their HbA1c level below the recommended 7 percent goal, compared to only one-quarter of placebo • Amgen Inc., of Thousand Oaks, Calif., reported patients. That’s a “really big deal,” he said.
that denosumab was superior to Zometa in preventing Rodman and Renshaw analyst Elemer Piros noted, skeletal-related events in breast cancer patients with bone however, that the drug did not signifi cantly improve fasting metastases. The Phase III study included 2,046 patients. insulin, triglycerides, cholesterol levels or blood pressure, Results were published in the Journal of Clinical Oncology.
which Piros said “further questions the clinical signifi cance • Ardea Biosciences Inc. reported that its of the effi cacy fi ndings.” Lief argued that improvements investigational drug RDEA594 in combination with were seen on “virtually all” of the secondary endpoints, febuxostat (Uloric) or allopurinol reduced uric acid levels although the small size of the trial may have complicated in patients with gout to a greater degree than either of the marketed drugs alone. The San Diego-based company Yet it has been safety, not effi cacy that has proven the completed enrollment in a Phase IIb study of RDEA594 with bigger stumbling block for lorcaserin lately, and the BLOOM- allpurinol in gout patients who failed allopurinol alone.
DM data raised additional questions in that department.
• Argos Therapeutics Inc., of Durham, N.C., said data The most common adverse events in the trial were from a Phase IIa trial of ARS-004, its Arcelis HIV program, headache, upper respiratory infection, back pain and demonstrated a signifi cant reduction in viral load and a delay nasopharyngitis. But Arena also said 2.9 percent of in viral rebound kinetics during a 12-week antiretroviral lorcaserin patients and 0.5 percent of placebo patients had treatment interruption when compared to pre-ART viral new valvulopathy at week 52, although the study was not loads. AGS-004 currently is in testing in a Phase IIb study powered to detect meaningful differences in valvulopathy.
co-funded by the National Institutes of Health. The Arcelis That tid bit had some investors fi red up because there technology is designed for personalizing RNA-loaded was less valvulopathy disparity between the lorcaserin To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
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$22 million agreement, Washington University scientists will review research data on drug candidates that currently ongoing development. One of the most notable examples of are or have been in clinical trials.
drug repositioning was sildenafi l citrate (Viagra), which was Another drug repositioning partnership with Gene being developed as an angina drug and was repositioned to Logic Inc. by Pfi zer produced a milestone payment in 2007 The concept behind drug repositioning is that disease pathways share druggable targets, and so a drug that seems to hit a target well, but fails for its intended disease ACR Roundup
indication, may be successful in another indication relevant to the same target. • Tonix Pharmaceuticals Inc., of New York, said And that’s where Biovista comes in.
results of a new analysis from a Phase IIa study showed that Persidis prefers not to refer to Charlottesville, Va.-based bedtime administration of very low dosage cyclobenzaprine Biovista’s Clinical Outcome Search Space (COSS) technology was associated with reductions in an objective measure of non-REM sleep instability, and those reductions were “We don’t call it software because it isn’t just software,” statistically signifi cantly correlated with diminished pre- Persidis said. “It’s a technology platform that matches the sleep/p.m. fatigue in fi bromyalgia syndrome. Previous data very deep description of the mechanism of action of every showed that the drug reduced pain, fatigue and tenderness drug against every one of the 23,000 diseases and 6,000 adverse events tracked by medicine.” (See BioWorld Today, • UCB SA, of Brussels, Belgium, and Immunomedics Inc., of Morris Plains, N.J., said results from the Phase IIb A typical COSS treatment for an individual drug will EMBLEM study showed that certain doses of epratuzumab take 30 to 60 days. The automation portion of the system were associated with a meaningful and statistically conducts real-time assays of the drug against its database signifi cant reduction in disease activity in adult of mechanisms and targets. After the initial data are patients with moderate to severe active systemic lupus returned, a team of therapeutic area experts processes the erythematosus. All dose ranges from 200 mg to 2,600 mg administered during one 12-week treatment cycle had The system differs substantially from a data mining numerically superior response rates compared to placebo application, which only turns up results that are present in at week 12, and for patients receiving epratuzumab at a the database. COSS creates results based on information cumulative dose of 2,400 mg, there were meaningful and in the database, which was created using a mix of publicly statistically signifi cant reductions in SLE disease activity, available data and proprietary data owned by Biovista or its with responder rates more than double those of placebo. In separate news, UCB reported data showing that the Biovista validated COSS using its own internal pipeline addition of Cimzia (certolizumab pegol) to current therapy of compounds, including BVA101 and BVA201 in multiple was associated with a rapid clinical response, improved sclerosis, BVA601 in epilepsy, BVA501 and BVA701 in function and reduced disease activity in a diverse group of adult rheumatoid arthritis patients. The 12-week Phase IIIb Biovista said that in 2009, it used COSS to fi le intellectual trial met its primary endpoint, with 51 . 1 percent of patients property claims for more than 60 drugs in nine different in the Cimzia group achieving ACR20 score vs. 25.9 percent indications including epilepsy, multiple sclerosis, advanced macular degeneration, Sjögren’s syndrome, Hodgkin’s lymphoma, multiple myeloma, diabetes, thyroid cancer and Other News To Note
In addition to the new collaboration with Pfi zer, Biovista has an existing relationship with the FDA’s Offi ce of Clinical • Acadia Pharmaceuticals Inc., of San Diego, has Pharmacology. In January 2010, the FDA announced that been awarded a grant from The Michael J. Fox Foundation it had licensed Biovista’s technology to help it analyze for the development of Nurr1-RXR agonists for the treatment of Parkinson’s disease. The company said that “We’ve been informally collaborating with the FDA for the grant of $300,000 was awarded under the foundation’s at least four years,” said Persidis.
Therapeutics Development Initiative aimed at supporting Pfi zer is working with a number of other partners preclinical development of Parkinson’s disease therapies to explore new indications for its compounds. In May that have the potential for fundamentally altering disease 2010, Pfi zer announced a collaboration with Washington course and improving treatment of symptoms above and University School of Medicine in St. Louis to attempt to beyond current standards of care. The grant is Acadia’s reposition more than 500 compounds. Under the fi ve-year, To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at Chemotherapy
of experiments, inhibiting translesional repair in animals with an aggressive form of lung cancer that was resistant with no overt signs of disease, but with a small reservoir of to cisplatin sensitized the animals to the chemotherapy, resistance cells left over that can pick up where they left off, Collectively, the authors wrote, the studies suggested But there is also suspicion that chemotherapy itself that “a treatment strategy based on pairing a DNA-damaging contributes to cancer cell resistance. “A lot of these chemotherapeutic agent . . . with a drug that inhibits the chemotherapeutic agents are DNA-damaging agents,” mutagenic [translesional synthesis] pathway could be very Graham Walker told BioWorld Today – and DNA damage is powerful, because it could reduce signifi cantly the rate at what is at the root of cancerous changes in the fi rst place.
In a paper published in the Nov. 8. 2010, online edition of Walker said that his team is currently searching for the Proceedings of the National Academy of Sciences, Walker, inhibitors that could be used in any future clinical studies, as who is an American Cancer Society research professor of well as delving into the basic biology of “which characteristics biology at the Massachusetts Institute of Technology and of the cancer would make it amenable to this approach.” a member of the Howard Hughes Medical Institute, and “Not all cancers are going to depend on translesional colleagues confi rmed that standard chemotherapy can synthesis to keep themselves alive,” he said, so “the hope indeed induce resistance to themselves in cancer cells. would be to try to identify cancers would be susceptible.” They also identifi ed a key cellular process in the induction Certain cancer cell lines express the polymerases in of such resistance, and suggested inhibiting this process question at very high levels, suggesting that they might be might be a way to prevent such resistance from emerging. good candidates for such a combination approach. The process Walker and his team set their sights on is Toxicity would also be a bigger concern with this translesional DNA synthesis, a DNA repair mechanism that approach than with more targeted therapies, since inhibiting is unique in that it can introduce mutations even as it is DNA repair would also affect healthy cells. Walker said that repairing DNA. As a rule, copying DNA needs to be an exact this is why it is important to look for cancers that rely heavily process, and so normal DNA polymerases – the enzymes on translesional repair. For such cancers, there is more likely that do the copying – are a fi nicky bunch. Anything unusual to be a therapeutic window where inhibiting this mechanism – missing bases, but also bridges between base pairs that kills cancer cells, while normal cells are “better able to shrug can be induced by ultraviolet light – will cause them to it off” and rely on alternate DNA repair mechanisms.
abandon their attempt to replicate DNA, which ultimately Walker noted that clinical trials are a good way off at best, but said the results his team has published are Translesional DNA repair, Walker said, is carried out encouraging enough to pursue the idea further – “and keep by “special classes of DNA polymerase that have a more fl exible and spacious active site.” It can help cells survive when their DNA is under assault – but at the cost that “now Clinic Roundup
you could put mutations in at the same moment you are repairing the DNA.” Walker, co-corresponding author Michael Hemann, • The FDA informed Endo Pharmaceuticals Inc., of and their colleagues looked at the relationship between Chadds Ford, Pa., that it will not be necessary to convene chemotherapy, resistance and translesional synthesis a joint meeting of the Anesthetic and Life Support Drugs because it is the most error-prone way of copying DNA. Advisory Committee and Drug Safety and Risk Management “There are lots of ways to repair [DNA] accurately,” Walker Advisory Committee to review its new drug application for said, “but only one major way to put in mutations.” long-acting oxymorphone for moderate to severe chronic In their papers, the authors looked at Rev1 and Rev3, pain. The agency is able to make its decision based on which are subunits of two different translesional DNA previous advisory committee meetings.
polymerases, though Walker said they tend to act in concert • Nabi Biopharmaceuticals Inc,, of Rockville, Md., completed enrollment of a second Phase III trial of NicVAX, In mice with lymphoma, Walker and his team a nicotine conjugate vaccine for nicotine addiction. The demonstrated through serial transplantation experiments new trial will evaluate abstinence from smoking over a that chemotherapy treatment led to mutations that made 12-month period in 1,000 patients. Secondary endpoints some cells resistant to the chemotherapy. Inhibiting include abstinence rate at various intervals, safety and translesional repair while administering the chemotherapy immunogenicity of the vaccine, withdrawal symptoms, reduced resistance, as well as tumor spread more generally.
cigarette consumption, smoking satisfaction and nicotine In a companion paper, they also showed that inhibiting dependency. The fi rst Phase III trial completed enrollment the same enzyme can overcome intrinsic resistance, that is, in July, with fi nal data expected in the fourth quarter of 2011. resistance not caused by the chemotherapy itself. In this set Results from the latest trial are expected in early 2012.
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traditional Asian dish, known as natto, which could then be together health and technology leaders, researchers, Chicago-based VaxTrac Inc. also won a grant to policymakers and community groups to discuss the use of test a mobile phone-based vaccination registry, which wireless technology for improving global health. uses fi ngerprint scans to track those who have received He insisted that vaccines for diseases, such as malaria, immunizations in hopes of reducing redundant doses and respiratory illnesses and viral diarrhea, will not only be the boosting coverage levels in developing countries.
key to improving global health, but in reducing poverty and While the focus of the mHealth Summit was advancing the use of cell phones, the Internet and other wireless Cutting the number of worldwide deaths – particularly technologies to improve global health, Gates cautioned in developing nations – also will reduce population growth, that “We have to approach these things with some Gates argued, noting that such an assertion “sounds humility,” noting that despite the rapid progress of mobile technologies, using them for health care delivery in some “The fact is,” he said, improving health outcomes results areas of the world without reliable electricity or cellular in parents in poorer nations having fewer children.
Gates noted that one southern region of India with He contended that the best environment to test health healthy residents has experienced a low population growth care innovation is “middle income” countries, such as Brazil in recent years, while a northern region, where vaccines, therapies and other health care is less accessible, has seen While rich countries, like the U.S., spend “huge amounts a 3 percent annual growth in population.
of money on its health system,” it also is heavily regulated, “No matter what problem you care about, the key thing with a “very strange” incentive system, such as better is those problems are insoluble at 3 percent growth rate,” reimbursements for acute care than for preventive care, he said. “Nobody can handle that type of situation.” Whether it is energy, biology or robots, Gates said most Also speaking at the mHealth Summit Tuesday was people underestimate the amount of innovation currently media mogul and billionaire Ted Turner, who said his best advice to innovators and entrepreneurs, was “early to bed, He said the greatest medical challenge currently early to rise, work like hell and advertise.” facing the planet is not a new disease, but the “tough time” Turner said he has experienced the same type of for foreign aid for vaccines and other global health care skepticism that all start-ups face, not just when he founded programs, with many governments slashing their budgets, CNN as an entrepreneur, but when he gave $1 billion to which Gates said may lead to a stifl ing of medical innovation.
establish the United Nations Foundation, a nonprofi t He noted that Italy recently cut its foreign aid for health charitable organization that advocates for the UN in solving “I hope it doesn’t get cut in the U.S., but I’m quite “It’s hard to raise capital when you don’t have an concerned it will be,” Gates lamented. established track record,” Turner said.
He added that the UK has so far been able to avoid Nonetheless, he said, “there are fewer barriers” in the cutting any foreign aid for health care.
business world than when he got started, “which is good.” ■ “In general, the world underfunds research,” Gates said.
Nonetheless, he praised the U.S. as being “exemplary” for providing the National Institutes of Health with a $30 Clinic Roundup
billion budget, which he noted largely goes to basic and early research.
• NeuroDerm Ltd., of Ness Ziona, Israel, started While Gates said he supported capitalism – “it’s better a Phase IIa trial of ND0801, a dermal patch based on a than government” – he noted that there is some research combination with nicotinic actions, in attention defi cit that the private sector just would not fund. disorders/attention defi cit hyperactivity disorder in adults. On the same day he spoke in Washington, Gates’ The study is expected to enroll 45 subjects and will examine foundation revealed 65 new winners of its Grand Challenges safety, tolerability and optimal therapeutic dose, as well as Explorations global health project grants.
Initial grants of $100,000 are awarded two times a year, • Nuvo Research Inc., of Mississauga, Ontario, with successful projects having the opportunity to receive reported that its investigational drug WF10 for allergic a follow-on grant of up to $1 million under the fi ve-year $100 rhinitis met its primary endpoint in a Phase II trial carried out million Gates Foundation initiative.
in Leipzig, Germany. In 60 patients with a two-year history Some of this year’s recipients included an Ohio of persistent allergic rhinitis and positive skin allergen test, State researcher who is developing a safe strain of the treatment with WF10 resulted in a signifi cant change in Total tuberculosis bacterium for use in fermenting beans in a Nasal Symptom Score without signifi cant adverse events.
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• Fabrus LLC, of La Jolla, Calif., has started a research program with Ambrx Inc., of San Diego, to discover antibodies with properties that are optimized • Advanced Life Sciences Holdings Inc., of Chicago, for use as antibody drug conjugates. Under the research submitted a proposal to the National Institute of Allergy and agreement, Fabrus will use its antibody library, screening Infectious Diseases for a biodefense contract that would and functional maturation approaches to deliver affi nity- advance development of intravenous antibiotic Restanza matured antibodies against a number of targets nominated (cethromycin) for bioterror pathogens. The drug is also in a by Ambrx. The collaboration antibodies will be modifi ed Phase III trial for community-acquired bacterial pneumonia by Ambrx, using its unnatural amino acid technology, following the receipt of a complete response letter last year. to produce antibody drug conjugates directed to each therapeutic target. The agreement grants Ambrx the • Aposense Ltd., of Petach-Tikva, Israel, signed exclusive right to commercialize conjugated forms of the a deal for Roche AG, of Basel, Switzerland, to use its antibodies generated under the collaboration. Fabrus will EarliTest solution with the oncology program at Roche. receive various up-front payments and is eligible to receive Data generated from the collaboration will provide an success fees and a share of certain payments received opportunity for the companies to expand the use of by Ambrx in the future. Ambrx was granted an option to EarliTest to oncologic therapies. Under the terms of the acquire a minority equity interest in Fabrus. (See BioWorld nonexclusive agreement, Roche will fund the clinical trials and pay Aposense undisclosed license and milestone fees.
• AtheroNova Inc., of Irvine, Calif., signed a research agreement for the second phase of a preclinical laboratory study with Cedars-Sinai Heart Institute’s Division of What You Missed in
Cardiology. The protocol for the study is to validate results BioWorld Insight Monday
from initial preclinical testing that showed 95 percent less occurrence of arterial plaque compared to the control It used to be that getting a drug approved was the • Chimerix Inc., of Research Triangle Park, N.C., most important thing a drug developer had to do. But reported data from in vitro studies showing that antiviral recently, several biotechs have won approval only to run agent CMX001 selectively inhibited the replication of human into trouble getting their drugs paid for – a problem that polyomavirus JC, the cause of progressive multifocal is likely to intensify thanks to comparative effectiveness. And when patients aren’t buying, potential partners immunosuppressed patients. The effect of CMX001 on JCV replication using human glia-derived cells was investigated, with data showing that extracellular JCV was reduced The Strategy Behind Maxygen’s Midas Touch by 50 percent by CMX001 in glia-derived cells. Data also The interesting thing about Maxygen Inc.’s recent showed the drug’s benefi t in monkey cell lines COS-7 cells. platform technology sale is that the biotech didn’t need Those results were presented at the Antiviral Congress in the cash. In fact, Maxygen has so much money that it has handed some $40 million back to investors over the • CMDBioscience LLC, of Orange, Conn., completed past year – something rarely seen in the biotech world. a research collaboration aimed at identifying peptide How did Maxygen end up in this enviable position, and antagonists of the dengue virus using its computational what happens when it runs out of assets to monetize? peptide drug discovery platform. Scientists were able to model and optimize a structure of the dengue viral target and evaluate more than 480,000 peptide ligand sequences, ultimately converging on the 27 most promising sequences. At law fi rm Foley & Lardner LLP’s annual life science Subsequent synthesis and testing revealed anti-infective conference, a panel of biotech experts guided two activity for fi ve of the designed peptide ligands.
fi ctional scientists through starting a biotech. From • EUSA Pharma Inc., of Oxford, UK, submitted a a breakdown of valuations to tips for accelerating the biologics license application for Erwinase (L-asparaginase patent process and landing a partner, the panel provided derived from Erwinia chyrsanthem) for use in acute both the basics and several surprises.
lymphoblastic leukemia patients with hypersensitivity to E. coli-derived asparaginase. The application is being Take BioWorld Insight for a test drive. Call (404) submitted on a rolling basis, following receipt of fast-track 262-5476 or (800) 688-2421 and mention Editor Trista status from the FDA, and the BLA requests a six-month Morrison for a free trial subscription.
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Copyright 2010 AHC Media LLC. Reproduction is strictly prohibited. Visit our web site at stated that if the company moved into Phase III at this time Other News To Note
it would do so at its own risk. Repros said the FDA accepted the notion of secondary hypogonadism associated with • GenVec Inc., of Gaithersburg, Md., said Nasdaq aging as an appropriate population and suggested that the granted the fi rm an additional 180 days to regain compliance next study involve men naïve to testosterone treatment with the minimum $1 bid price rule for continued listing. or off testosterone treatment for at least six months. As outlined in the company’s protocols, the FDA requested • Immunologix Inc., of Charleston, S.C., entered a that the trial consist of four arms: placebo, two doses deal with contract research organization GenScript, of of Androxal and topical testosterone. Endpoints should Picataway, N.J., to offer a complete platform for producing consist of total testosterone and sperm counts at the end human antibody therapeutics. Financial terms were not of the study compared to baseline. Repros said it agreed with the FDA’s comments and noted it would analyze the • Immunovaccine Inc., of Halifax, Nova Scotia, previously completed ZA-003 study for the subset of men reported that a preclinical study testing the effi cacy of with morning testosterone less than 250 ng/dl and submit combining its DepoVax with CEL-2000, a rheumatoid the data. Shares of Repros (NASDAQ:RPRX) fell 27 cents, or arthritis vaccine antigen from CEL-SCI Corp., of Vienna, 17.8 percent, to close Tuesday at $1 .25.
Va., showed a single-dose of the combination product • Semafore Pharmaceuticals Inc., of Indianapolis, considerably lessened the symptoms and slowed the received orphan drug designation from the FDA for SF1126 progression of rheumatoid arthritis in an animal model.
in B-cell chronic lymphocytic leukemia. SF1126 is a peptidic • Insight Genetics Inc., of Nashville, Tenn., was awarded prodrug of the PI3K and mTOR inhibitor LY294002 and is a $200,000 Phase I Small Business Innovation Research contract from the National Cancer Institute to develop a • Shire plc, of Dublin, Ireland, announced that its companion diagnostic for lung cancer patients. As part of wholly owned subsidiary Shire Holdings Luxembourg the contract, the company will further validate its ALK Screen Sarl has acquired all of the issued shares and warrants of real-time PCR-based test, which is aimed at detecting cancer- Movetis NV, of Turnhout, Belgium, and that shares in causing fusions and mutations of anaplastic lymphoma Movetis have been delisted from Euronext Brussels. Shire kinase, using lung cancer specimens. About 5 percent to 10 Holdings Luxembourg acquired 99.21 percent of the shares percent of lung cancers are caused by ALK mutations.
of Movetis on Oct. 12 following a successful tender offer • Omeros Corp., of Seattle, announced that a compound launched in September. (See BioWorld Today, Aug. 4, 2010.) identifi ed by the company as an antagonist of GPR87, an • Synageva BioPharma Corp., of Waltham, Mass., orphan GPCR recently unlocked for drug development by received orphan product designation from the European Omeros and linked to squamous cell carcinoma, potentiates Medicines Agency for SBC-102 (recombinant human the tumor-killing activity of doxorubicin (Adriamycin), a lysosomal acid lipase), an enzyme replacement therapy widely used chemotherapeutic agent. The company said for lysosomal acid lipase defi ciency. The drug previously it is the fi rst compound in a series of GPR87 antagonists received orphan drug status from the FDA. exclusively identifi ed by Omeros that the company has evaluated in proof-of-concept models. Omeros said that Clinic Roundup
it is initiating medicinal chemistry optimization of the compound. (See BioWorld Today, Oct. 26, 2010.) • The FDA approved an investigational new drug • PolyMedix Inc., of Radnor, Pa., announced that application from Oxford BioMedica plc, of Oxford, UK, for data from two separate preclinical research studies were a Phase I/II trial of RetinoStat for wet age-related macular published in the December 2010 issue of Molecular Oral degeneration (AMD). RetinoStat is a gene therapy using the Microbiology and, according to the company, demonstrated company’s LentiVector gene delivery system. The trial will that investigational defensin-mimetic compounds exhibited be carried out at the Wilmer Eye Institute at Johns Hopkins both anti-infl ammatory and antimicrobial activity against in Baltimore and will enroll 18 patients with wet AMD to microbial biofi lms that cause infections of the oral cavity. evaluate three dose levels of the drug.
It is the fi rst scientifi c publication of the discovery of anti-infl ammatory activity with PolyMedix’s defensin-mimetic compounds, the company said. • Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA recommended during a recent Type Promote it on your website or in your investor kit! B meeting that a Phase IIb study of Androxal in men with secondary hypogonadism but naïve to testosterone For high-quality reprints of articles about your
treatment would provide a more solid data base for design company, please contact Stephen Vance at (404)
of Phase III studies and eventual approval of such studies 262-5511, or [email protected]
under a special protocol assessment. The agency further To subscribe, please call BIOWORLD® Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.
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