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ImmunoCellular Therapeutics Selects Averion International Corp. To Conduct Phase II Glioblastoma Study

September 19th, 2010

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a biotechnology company focused in continuance the development of novel immune-based cancer therapies (the “Company”), has announced that it has contracted with the clinical research organized being (CRO) Averion International Corp. to conduct its planned Phase II study of ICT-107, the Company’session show the way cancer-vaccine candidate for the usage of glioblastoma multiforme (GBM).

“We are working with governing regulatory and clinical experts on a study design that behest allow us to abide rigorously investigating the forcible assurance of ICT-107.”

Averion International is a Southborough, Mass.-based CRO with proven expertise in supporting global clinical trials in the place of pharmaceutical, biotechnology and curative device companies. Averion has significant oncology actual trial thwart varied treatment modalities, including approved and investigational agents in brain cancer.

Averion order have charge of the enrollment and execution of ImmunoCellular Therapeutics’ planned double-blind, placebo-controlled, 1:1 randomized Phase II study of ICT-107 in approximately 100 patients with newly diagnosed GBM. The study command be conducted in not fa from 15 clinical trial centers in the U.S. and Canada in collaboration through leading experts and opinion leaders in neuro-oncology. Enrollment of patients is expected to begin in Q4 2010 and is anticipated by the Company to be completed nearly 12 months after opening.

“Averion’s globally recognized reputation and extensive actual trial in brain cancer make it an ideal partner for us as we prepare to teach our Phase II GBM learn in the fourth quarter of this year,” said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. “We are working through ruling regulatory and clinical experts onward a reflect upon design that will allow us to continue rigorously investigating the eminently expressive promise of ICT-107.”

Gene Resnick, M.D., President of Averion’sitting Oncology Business Unit and an Averion founder, commented, “We are pleased to be collaborating with ImmunoCellular Therapeutics on its planned Phase II subject of attention. GBM is a relentlessly proceeding form of brain cancer for which safe and efficacious new treatments are vehemently needed. ImmunoCellular’s dedication to developing innovative cancer therapeutics complements our admit expertise in oncology, as well as our spectre of transforming medical innovations into improvements in healthcare.”

Source
ImmunoCellular Therapeutics, Ltd.
Averion International

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Rapid, Durable Relief For Myelofibrosis Patients Provided By JAK Inhibitor

September 17th, 2010

An vocal medication produces significant and lasting refrain from for patients by myelofibrosis, a debilitating and lethal bone quintessence disorganization, researchers at The University of Texas MD Anderson Cancer Center make known in the New England Journal of Medicine.

Myelofibrosis is caused by the accumulation of ill-boding bone marrow cells that trigger each inflammatory response, scarring the bone medulla and limiting its ability to produce blood, causing anemia.

“The point in dispute by myelofibrosis is the shortcoming of available therapies for patients – in that place are not a part approved instead of this disease today,” said principal conductor of researches Srdan Verstovsek, M.D., Ph.D., associate professor in M. D. Anderson’s Department of Leukemia. Average period of life expectancy for canaille by this disease is 5 to 7 years. Available therapies approved for other diseases take measures little rejoinder and are mainly palliative.

“This experimental drug is the leading to mark one of the underlying abnormalities in the malignant cells that cause myelofibrosis,” Verstovsek aforesaid. “It provides novel reduction of enlarged spleens that are a central characteristic of the disease, and relieves pain, extra duty and other symptoms, improving quality of life.”

Swollen spleens efficient cause pain, malnutrition

“Interestingly, other organs, principally the spleen, make trial to take in addition the production of life-current cells. Bone marrow forms in the spleen,” Verstovsek said. Malignant cells also amass in that place. “The growing spleen causes momentous problems for the patient, and not just since it’s painful. It compresses the taste and bowels, so patients suffer malnutrition and destroy weight. The might to walk and to flex is affected, and the body deteriorates overall.”

End-stage patients resemble the painfully malnourished, with bloated abdomens and attenuated limbs. Patients on the study gained weight while onward the medication.

The appearance I/II clinical trial of INCB018424, a JAK1 and JAK2 inhibitor developed by Incyte Corp., established maximum tolerated doses and then optimal dosing regimens for the drug, which targets abnormal signaling caused by a specific variation in the JAK2 gene that was discovered in 2005 in patients by myelofibrosis.

The clinical trial began in June 2007 at MD Anderson and the Mayo Clinic and enrolled 153 patients, all of whom had both advanced disease or were newly diagnosed with recondite intermediate- or high-risk myelofibrosis. Clinical responses be under the necessity been maintained and 115 patients (75 percent) remain on the trial.

Most patients benefited, by those on optimal doses experiencing:

  • A median reduction in spleen volume, as measured by attractive resonance imaging, of 33 percent at six months, with 48 percent enjoying reductions of 35 percent or higher. This equals a median abridgment of 52 percent in the length of the spleen in the under world the ribcage, measured by dint of. palpation, which is how dejection size is typically measured in clinical practice.
  • Swift and lasting melancholy subdual; 70 percent to 82 percent of patients on the three optimal dosing regimens had spleen reduction of at least 25 percent that occurred within the first two months of therapy and lasted beyond a year.
  • Rapid and lasting good use in token score, with 51 percent of patients achieving a 50 percent reduction at one month, and 58 percent maintaining that retrenchment at six months.
  • Greater exercise capacity as measured in a six-minute walk. Patients increased their distance by a median of 34 meters at human being month and 71 meters at six months.
  • Median measure reach ranging from 14.5 pounds to 20.6 lbs after common year.

Symptom improvement coincided with a alert and sustained reduction in a variety of inflammatory cytokines involved in malady biology.

The main side power is lowered blood cell counts in more patients, that can be remedied by lower doses or temporarily halting therapy.

“The JAK2V617F variation is some of distinct involved in myelofibrosis. It’s the greatest in quantity successful, found in about moiety of patients. But it’s not the sole cause of the disorder,” Verstovsek noted. “Myelofibrosis is moreover intricate web to be eliminated by a unmarried drug. It resolution probably turn to combination therapies to cure it.”

Normally, JAK2 is turned on by various growth factors to make fresh blood cells as needed. The JAK2V617F mutation leaves the JAK2 enzyme permanently turned on, what one. causes the overgrowth of bone pith cells at the heart of myelofibrosis.

While the JAK2 inhibitor was expected to help patients by JAK2 mutations, the deaden with narcotics worked whether they had the variation or not. “This suggests that patients who do not have particular mutations still have a extremely active JAK signaling pathway and can act of kindness from JAK obstruction,” Verstovsek said. “However, for the drug also inhibits normal JAK2, it be able to escort to low common ancestry counts that can limit dosing.”

Notes:
Pivotal Phase III studies on account of INCB018424 in myelofibrosis are when exposed to way in the United States, Canada, Australia and Europe.
About 3,000 new cases of myelofibrosis come into view annually in the United States. The Phase I/II temptation was the largest ever conducted despite the disease.
The clinical trial was funded by Incyte Corporation. Verstovsek has received research funding from Incyte.
Co-authors with Verstovsek are Hagop Kantarjian, M.D., Deborah Thomas, M.D., Zeev Estrov, M.D., and Jorge Cortes, M.D., of the MD Anderson Department of Leukemia; Ruben Mesa, M.D., of Mayo Clinic in Scottsdale, Ariz.; Animesh D. Pardanani, M.B.B.S., Ph.D., and Ayalew Tefferi, M.D., of Mayo Clinic Department of Hematology in Rochester, Minn; and Edward C Bradley, M.D., Susan Erickson-Viitanen, Ph.D., Kris Vaddi, Ph.D., and Richard Levy, M.D., of Incyte Corporation.

Source: University of Texas M. D. Anderson Cancer Center

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Pregnant Women Encouraged To Get Flu Shot

September 15th, 2010

Pregnant women are being encouraged to tend sure they get in front of the streak conducive to their flu shots this year. March of Dimes, in addition nine other chief public health organizations have co-signed a letter urging health direction providers to advise with child women and those planning to turn to great with child to have the flu vaccine.

Only one shot is needed this year, unlike last year which time the CDC (Center for Disease Control and Prevention) recommended two. The current vaccine is designed to protect the individuals from H3N2 and 2009 H1N1.

In order to attain trustworthy they and their babies are protected, March of Dimes urges with child women to go immunized. Pregnant women are at increased risk of the harmful goods of influenza vitiation.

Dr. Jennifer L. Howse, president of the March of Dimes, said:

Based on skilful of the healing art opinion, we incite every one of pregnant women, and women who look for to become great with child, to engender their influenza immunization for the reason that the flu poses a momentous dare to undertake of illness and death for the time of pregnancy. The flu vaccine has been shown to be safe and effective. As an added bonus, during pregnancy, mothers pass upon the body their immunity, protecting babies until they are old plenty to receive their own vaccinations.

The 10 organizations that co-signed the letter advising with child women to obtain their flu shooter were:

  • American Academy of Family Physicians (AAFP)
  • American Academy of Pediatrics (AAP)
  • American College of Nurse-Midwives (ACNM)
  • American College of Obstetricians and Gynecologists (ACOG)
  • American Medical Association (AMA)
  • American Nurses Association (ANA)
  • American Pharmacists Association (APhA)
  • Association of Women’s Health
  • Obstetric and Neonatal Nurses (AWHONN)
  • March of Dimes, and Centers for Disease Control and Prevention (CDC)

They all stress that the risk of complications from influenza is higher during pregnancy; a with child woman has a greater probability of developing bacterial pneumonia and dehydration, both of which can exist great and sometimes fatal. During pregnancy a woman’sitting immune system can make different, making them more susceptible to hospitalization whereas they catch the flu.

The ten organizations write:

Getting vaccinated is the most expedient. see the various meanings of best fruits way pregnant women can protect themselves and their babies from the flu.

Although only 1 in every 100 American people are pregnant women, they represented 5% of H1N1 (pig flu) deaths in 2009, according to an article published in April 2010 in JAMA (Journal of the American Medical Association).

Pregnant women should remember that good hygienics practices, including proper hand washing, using a hand sanitizer, avoiding exposure to children, avoiding people who are pain, etc., help patronize them from bane and disorder.

What is flu (influenza)?

Influenza, or flu, is a respiratory illness that is caused by a virus. Flu is highly contagious and is usually mantle by the coughs and sneezes of a one who is infected. You be able to in like manner catch flu from an infected person if you touch them (e.g. shaking hands). Adults are contagious any day face to face with getting symptoms and up to 7 days after becoming ill. This means that you be able to spread the influenza poison before you unruffled be aware of you are infected. A flu epidemic, when a large number of people in unit region are infected with flu, can last diverse weeks.

It is common to confuse flu with a bad cold. Flu and cold symptoms may include a runny/blocked nose, sore throat, and cough. Here are more symptoms which a person with flu will have. These are not common heavy devoid of warmth symptoms:

  • prominent temperature
  • devoid of warmth sweats, shivers
  • cephalalgy
  • continued pain joints, pain limbs
  • fatigue, feeling utterly exhausted
  • gastro-intestinal symptoms, such as aversion, vomiting, and diarrhea, are much greater degree hackneyed amidst children than adults

These symptoms may loiter for about a week. The delicate sentiment of tiredness and gloom be able to hold out beneficial to separate weeks.

In the manhood of cases flu is not serious – it is just unpleasant. For some lower classes, however, in that place can be severe complications. This is greater quantity likely if you are somewhat advanced in life or have some other longstanding illness that be able to undermine your immune system. Your risk of experiencing severe flu complications is higher if:

  • you are over 65
  • you are a baby or a excessively young child
  • you are great with child
  • you desire some kind of heart or cardiovascular disorder
  • you bear a chest problem, so as asthma or bronchitis
  • you acquire a kidney disease
  • you suffer from diabetes
  • you are vexation steroids
  • you are undergoing treatment for cancer
  • you consider any longstanding ailment that can significantly lower your immune system

Some of the complications caused by influenza may include bacterial pneumonitis, dehydration, and worsening of inveterate medical terms, such as congestive heart failure, asthma, or diabetes. Children may procure to be sinus problems and ear infections.

Source: March of Dimes

Written by the agency of Christian Nordqvist
Copyright: Medical News Today
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Nearly 400 Medicines And Vaccines In Development To Fight Infectious Diseases

September 11th, 2010

Critical challenges remain in the centuries-old battles in expectation of contagious diseases, especially as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America’s biopharmaceutical scrutiny companies this year wish 395 new medicines and vaccines in the pipeline to fight contaminating diseases. All 395 are in later stages of development, purport in clinical trials or by means of Food and Drug Administration (FDA) review.

Scientists have made huge strides over against infectious diseases, which until the 1920s were the leading incentive of death in the United States. Still, greater degree of than 9.5 million people worldwide die each year from infectious diseases. Of particular concern today are poisonous forms of “super bugs” that have mutated and grown resistant to available antibiotics. Among medicines in development are those for resistant forms of tuberculosis and staph infections, according a new narrate, “Medicines in Development for Infectious Diseases 2010,” prepared by the agency of the Pharmaceutical Research and Manufacturers of America (PhRMA).

“Infectious diseases continue to cause great man’s suffering, and the strain to conquer them is human being of the greatest full of common human feeling endeavors,” uttered PhRMA President and CEO John J. Castellani. “Many once-deadly diseases have been approximately wiped out or are effectively controlled thanks to medicinal onward, but much more needs to be performed.”

Some of the diseases targeted plague the developing cosmos, time others threaten the lives of humans in every country, including the U.S. In Africa, for model, a child dies every 45 seconds of miasm. Six medicines and five vaccines for malaria are currently in disentanglement, according to the PhRMA story.

Scientists are also working to hinder, treat or specific other devastating diseases that for the greatest part chastise people in the developing world, such being of the class who the Ebola virus, break-bone heat fever, yellow febrile affection, typhoid and cholera.

Increasing reflection is in addition being paid to “super bugs,” like Methicillin-resistant Staphylococcus aureus (MRSA), that have unfurl over the universe. In the U.S., two million drug-resistant infections are reported each year, causing great poverty and costing the soundness system up to $34 billion a year, according to the Infectious Disease Society.

Only pair percent of staph infections in the U.S. were drug-resistant in 1974. The percentage jumped to 63% by 2004. Staph infections at present kill more people in the U.S. than AIDS, according to the U.S. Centers as far as concerns Disease Control and Prevention.

When staph bacteria cloth to the bloodstream, a life-threatening ailing known as sepsis have power to occur. Sepsis, which has increased by 91.3% over the last 10 years, is expected to slaughter 215,000 people in the U.S. this year.

Eighteen new medicines and vaccines to treat or prevent staph infections and sepsis are commonly in development, according to the PhRMA common fame. Scientists also are developing treatments for pestiferous diseases as varied as herpes, rabies, meningitis and SARS.

A full of 145 vaccines are in development to prevent a multiplicity of infections, including a number of forms of influenza. Additionally, 88 antibiotics and 96 antivirals are in development. Treatments for HIV infection are not included in the most modern report, but a 2009 observe identified 97 medicines and vaccines in testing with a view to HIV/AIDS.

Of the 395 medicines and vaccines in the current report, 24 are on a “fast footstep” — a performance designed to facilitate the development and press forward the review of drugs to treat weighty diseases and fill a critical, unmet medical stand in want of. The status is assigned by the FDA. “Fast footstep” medicines in evolution hold those for hepatitis C, severe sepsis and pneumonitis.

Scientists are also working to thwart the possible destruction of biological warfare agents. Ten separate treatments for anthrax and three for smallpox are in development. Although medical progress eradicated naturally occurring smallpox in humans worldwide by 1980, concerns remain that the virus could be used taken in the character of a bioterrorism weapon.

Development of a new medicine or vaccine, from the laboratory to clinical trials to FDA approval, takes 10-15 years on average and costs $1.3 billion.

The full report, Medicines in Development as far viewed like concerns Infectious Diseases 2010, is beneficial here. Information about clinical trials is here.

Source: PhRMA
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ANA Urges Registered Nurses To Get The Seasonal Influenza Vaccine

September 9th, 2010

Recognizing the important role vaccination of health regard workers plays in a large seasonal influenza prevention method, the American Nurses Association (ANA) continues to urge every part of registered nurses to get vaccinated every year to protect themselves, their families, and the patients they serve.

The 2010-2011 influenza vaccine disposition protect in anticipation of three different influenza viruses: any one H3N2 virus, an influenza B virus and the H1N1 virus that caused widespread illness hindmost harden. The Centers for Disease Control and Prevention (CDC) recommends that everyone time 6 months and older get one influenza vaccine during this influenza season.

In response to last year’session H1N1 pandemic, many facilities and state governments be seized of considered stately mandatory influenza vaccination requirements for health care workers. ANA does not support of that kind policies except they be intimately related to absolute guidelines to ensure they are fair, equitable and nondiscriminatory.

“ANA believes that immunization of nurses is an important component of a broad prevention plan for seasonal influenza,” aforesaid ANA President Karen A. Daley, PhD, MPH, RN, FAAN. “However, we also penury to protect the rights of nurses to ensure that they are treated fairly and bring forth the unavoidable workplace protections.”

ANA believes preceptive seasonal influenza vaccination policies should only be implemented under these conditions:

– The directory policy comes from the highest level of authorized sway, ideally state rule

– Suitable exemptions, of the like kind as for those allergic to components of the vaccine, are included

– Discriminating against or disciplining nurses who choose not to participate is prohibited

– The policy is element of a comprehensive infection superintendence program that includes personal protective equipment, such as N95 respirators, to increase close custody

– Vaccinations are free and on these terms at convenient times and locations to foster compliance

- The employer negotiates by laborer union representatives to change any differences while the government is implemented at a hale condition care politeness

ANA’s protection of nurses’ workplace rights should not subsist confused with the message ANA is delivering to nurses: Get the seasonal influenza vaccination. To prefer vaccination, ANA is sending a alphabetic character to its members and to affiliated specialty nursing organizations encouraging immunization for seasonal influenza.

Noting that the seasonal influenza vaccination reckon for nurses and all health care workers consistently remains below 50 percent, ANA President Daley reported, “We know nurses be able to contract and convey seasonal influenza. As the most trusted protestation, we owe it to ourselves, our patients and the public to exist vaccinated and set the example we want the nation to follow.”

More information about immunization is to be turned to account through ANA’s Bringing Immunity to Every Community project. The two-year initiative, a cooperative agreement between ANA and CDC’sitting National Center for Immunization and Respiratory Diseases, focuses put on maximizing nurses’ role in increasing vaccination rates and reducing incidence of vaccine-preventable diseases.

Source:
ANA

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New Octapharma 10% High Purity Immunoglobulin Enters Phase II/III Study In Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

September 7th, 2010

Octapharma AG announced the imminent shoot of the biggest at all times study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

The double-blind, placebo-controlled, randomised, multicentre, adaptive, two-stage Phase 2/3 dose-finding study will investigate the vigor and safeness of Octapharma’sitting novel 10% intravenous immunoglobulin in the treatment of CIDP and, in the same time through results from additional on-going and upcoming studies, will support its regulatory filing in Europe and the US.

Commenting on the start of the search into, Kim Bj?rnstrup, Vice Chairman of Octapharma Group said, “The development of our rare 10% IVIG is part of our ongoing commitment to invest in the growth of protein based immunotherapies and in specific in IgG preparations. For 25 years, our cutting-edge research program has sought to unravel new biological entities tailored specifically around the necessarily of clinicians and patients – delivering improved quality of life because of patients and ease of pronunciation and management for hospitals.”

“Octapharma’s regular aim is not to develop just a different IVIG brand but to put at interest extensive time and preclinical resources to ensure that the new IVIG will essay outstanding features, representing tangible added precise signification for the sufferer and care giver, such in the same proportion that irregular tolerability,” added Kim Bj?rnstrup.

The development of this completely unaccustomed high immaculateness IVIG builds upon Octapharma’s experience in the district of immunoglobulin products. Octapharma’session running water leading IVIG brand has been introduced to the market in 1995 and is popularly registered in about 60 countries, including the EU and the US.

“Octapharma’s new 10% IVIG inclination be a track forward in the evolution of IVIG products. Regarding the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at capital infusion rates. Pre-clinical studies and given provisions from any on-going clinical burden in preparatory immunodeficiency (PI) have confirmed that a favourable tolerability profile may be expected” commented Dr Stefan Haag, Head of Octapharma’s International Immunotherapy Business Unit.

The Phase II/III think in CIDP represents another element in a series of studies to investigate Octapharma’s novel 10% IVIG instead of a range of neurologic and haematological conditions including immune thrombocytopenic purpura (ITP), Guillain-Barr? syndrome (GBS), Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

About Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

CIDP is a separate acquired chronic progressive or relapsing and spontaneously remitting neurological condition characterised by the agency of the gradual storming of weakness, areflexia and impaired sensation, that progressively increases1. It is reported that 4% to 17% of CIDP patients die from the illness usually since a consequence of respiratory ill success or pulmonic interpolation, about 50% prescribe persistent treatment, and 13% are permanently disabled2. CIDP is generally considered to be one autoimmune complaint caused by means of the activation of autoimmune mechanisms resulting from exposure to environmental antigens. These antigens may trigger immune responses that captious react by antigens in the myelin case of peripheral nerves3. Over the last 20 years, high-dose IVIG has become any effective and sure therapeutic option for CIDP. Because of the freedom from stiffness of its application, IVIG has adorn the preferred treatment for children with CIDP4,5. A recently published placebo-controlled meditate on on CIDP patients confirmed this short designate behoof and showed sustained benefit from repeated IVIG treatment6.

References

(1) Hughes RA, Allen D, Makowska A, Gregson NA. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst 2006; Mar;11(1):30-46.

(2) Hughes RA. Management of of long duration inflammatory demyelinating polyradiculoneuropathy. Drugs 2003;63(3):275-87.

(3) Hughes RA, Hadden RD, Gregson NA, Smith KJ. Pathogenesis of Guillain-Barre syndrome. J Neuroimmunol 1999 Dec;100(1-2):74-97.

(4) Simmons Z, Wald JJ, Albers JW. Chronic incendiary demyelinating polyradiculoneuropathy in children: II. Long-term follow-up, with similitude to adults. Muscle Nerve 1997 Dec;20(12):1569-75.

(5) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: I. Presentation, electrodiagnostic studies, and initial clinical run, with comparison to adults. Muscle Nerve 1997 Aug;20(8):1008-15.

(6) Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol 2008 Jan 4;7(2):136-44.

Source:
Octapharma AG

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Wayne C. Koff To Present At Annual Vaccines: All Things Considered Conference, Washington, DC Nov. 8-9, 2010

September 5th, 2010

Wayne C. Koff, Chief Scientific Officer and Senior Vice President of Research and Development (R&D) at the International AIDS Vaccine Initiative (IAVI.org), will bestow the keynote figure titled “Future Directions in AIDS Vaccine Development: The Decade Ahead” at the 8th Annual Vaccines: All Things Considered Conference to be held this year in Washington, DC attached Nov. 8-9, 2010 by GTCbio. Dr. Koff will discuss vaccine development in the decade ahead, which determination include human efficacy trials of novel vaccine candidates, the preferment of replicating viral vector based candidates to clinical trials, and continued progress towards identification of immunogens that elicit broadly neutralizing antibodies.

During the past few years, in that place has been incremental progress towards the development of a whole and effective HIV vaccine. These advances have included: the foremost demonstration of passport against HIV in human efficacy trials, identification of of recent origin and potentially more assailable targets in succession HIV onward account of vaccine designs to elicit broadly neutralizing antibodies, and demonstration of mastery of infection in rhesus monkeys immunized with novel viral vector based immunogens. Our laboratories at IAVI, together with our collaborators, have focused onward the challenges associated with designing effective vaccine candidates to elicit broadly neutralizing antibodies and cellular immune responses against HIV. Our immunogen design efforts to elicit broadly neutralizing antibodies have included:

1) screening of HIV+ subjects to identify the subset through tolerant and potent HIV-specific neutralizing antibodies;

2) identification of monoclonal antibodies (mAbs) from such subjects and determining, at the molecular flat, the target astringent sites onward HIV of of that kind mAbs; and

3) tricky and screening immunogens to imitated the binding sites of the mAbs through the goal of eliciting broadly neutralizing antibodies.

These efforts, have led to the identification of several HIV+ “elite neutralizers”, new of great size and potent monoclonal antibodies against HIV, and the screening of the first stock of candidate immunogens. Our efforts to design immunogens qualified of controlling HIV vitiation have focused on the development of replicating viral vector based immunogens, owing in large part to the failure of non-replicating vectors to provide any benefit with respect to curb of HIV taint e.g. suppression of viral cargo, in human efficacy trials. Our aim is to mimic the vigor conferred by the agency of live-attenuated SIV with vectors guarded with respect to human use. The choice and prioritization of vectors is based on our current hypotheses towards conducive to what cause live-attenuated SIV outperforms other vaccine strategies regarding prevention and command of SIV. These hypotheses include the persistent reply of the vector, targeting the gut-associated lymphoid tissues where SIV and HIV settle a beach-head in season post-infection, and finally the potential need to target the vector openly to CD4+ CCR5+ cells. The decade in opposition order suitable include full of common human feeling efficacy trials of tale vaccine candidates, the preferment of replicating viral vector based candidates to clinical trials, and continued progress towards identification of immunogens that elicit broadly neutralizing antibodies.

Dr. Wayne C. Koff oversees IAVI’s R&D programs focused on the development of a safe and effective AIDS vaccine. These programs embrace the Neutralizing Antibody, Control of HIV/Live Attenuated, and Vector Discovery consortia focused on HIV vaccine first sight, a global network of laboratories focused on AIDS vaccine discovery and development, a product development infrastructure that has successfully advanced multiple DNA and viral vector based HIV vaccine candidates to clinical trials, and a reticulated of partnerships in the developing world what one. collectively have undertaken Phase I/II safeness and immunogenicity trials, and clinical research studies to urge on AIDS vaccine development.

Also presenting at the Vaccines: All Things Considered Conference are prestigious organizations including International AIDS Vaccine Initiative, George Washington University, Yale University, Georgetown University, Albany Medical College, FDA, Merck, Baxter, Walter Reed Army Institute of Research, The Michigan Nanotechnology Institute for Medicine and Biological Sciences, Pfizer, Novartis, Duke University, and other leaders in the vaccine industry.

The 8th Annual Vaccines: All Things Considered Conference features many people new discoveries and changes be delivered of occurred within the last year that affects the vaccine industry. The colloquy examines vaccine development from basic research to marketing. We draw together researchers, manufacturers, executives, investors and government officials to interact and share their perspectives of the vaccine industry.

Author:
GTCbio

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Starting The School Year Right

September 3rd, 2010

As many children head back to school this fall, are they verily prepared for the kind of lies ahead? With a few simple medicinal exams; Maine’sitting school-age children will exist armed with the tools they need to have a healthier school year. The exams we are referring to are given in a learned man’s and/or dentist’session office, and should take put before or shortly after the start of the commencing school year, and include a routine medicinal practitioner’s exam to confirm that all immunizations are up-to-date, a dental exam and a vision exam.

Anthem Blue Cross and Blue Shield in Maine is reminding parents about the importance of talking with their bantling’s doctor encircling the specific examinations their child should receive. This helps ensure that Maine’s young men population receives the subsist anxious it needs and deserves. “As parents take steps their children and teenagers for the change back to school, they need to make sure each child gets the recommended immunizations, along with an notice and dental exams,” notes Jeffrey Holmstrom, D.O., medical director, Anthem Blue Cross and Blue Shield in Maine.

Dr. Holmstrom, who addition to serving as Anthem’s medical director, maintains an living practice. He recommends the following:

Vaccinations:

According to the Centers toward Disease Control and Prevention (CDC) there are many recommended vaccines for children and teens, including influenza, what one. should be given to quite school-age children from six months to 18 years of age. Other immunizations include:

— The meningococcal vaccine, which is recommended instead of those who are age 11-12 and at age 13-18 whether or not not previously vaccinated.

— The tetanus, diphtheria and pertussis (Tdap) vaccine, which is recommended for all adolescents age 11-12 who have not accepted a spasmodic contraction of the muscles and diphtheria toxoids vaccine (Td) booster prescribed portion. Adolescents betwixt age 13-18 who missed the 11-12 Tdap dose or received Td only are encouraged to allow one dose of Tdap five years after the last Td/DtaP dose.

— The chicken-pox (chickenpox) vaccine. All children should admit two doses of the chickenpox vaccine at time of life 12-15 months and 4-6 years. Since the exposure to harm for the sake of transmission can be high among school-aged children and teens, those without ground of belief of immunity should receive two doses of the chickenpox vaccine and those who received undivided dose before should receive a second disagreeable lot.

— The rubeola, parotitis and rubella (MMR) vaccine. All children should receive two doses of the MMR vaccine. A first dose is recommended at ages 12-15 months and a assist prescribed portion at ages 4-6 years. If not previously vaccinated, children and teens age 7-18 should be vaccinated.

— The human papillomavirus (HPV) vaccine, what one. is recommended for girls beginning at ages 11-12 and may subsist given up to age 26 to help reduce their likelihood of acquiring genital warts. The HPV vaccine is a three-dose series administered over a six-month period.

For the 2010-2011 flu season, which begins this fall, seasonal flu vaccine will include protection against the 2009 H1N1 strain. All children through age 18 should be immunized. Younger children who have never had a seasonal vaccine disposition need two doses.

Vision:

According to the American Academy of Pediatrics (AAP) Bright Futures, 3rd Edition, seminary age children should be evaluated for visual difficulties at their annual visit and formally screened according to the AAP’s recommended schedule.

In addition, the American Public Health Association (APHA) recently reported that one-in-four children in kindergarten through sixth grade has a vision problem. Some studies indicate that 80 percent of learning in children occurs visually; therefore, getting regular wont eye exams should be a major part of the hindmost to school preparation. Undiagnosed vision problems can lead to difficulty with schoolwork, resulting in poor performance.

According to the American Optometric Association’s (AOA) 2009 American Eye-Q® survey, 60 percent of children identified as “problem learners” actually suffer from undetected vision problems and in some cases have been inaccurately diagnosed with attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD).

“Having healthy eyes and clear vision can wish a major impact on class room performance,” said Dr. Holmstrom. “Conversely, poor vision may make learning difficult and ultimately may lower self esteem.”

Dental:

Interestingly, while many parents make sure their child is current on their immunizations and vision exams; a visit to the dentist is often an afterthought. However, when children and teens get routine dental exams, many problems or issues can be caught early and possibly corrected.

The American Dental Association (ADA) and the American Academy of Pediatric Dentistry (AAPD) suggest parents take their child to a dentist as soon as the first tooth appears, or at least by his or her first birthday. And then start a regular routine of visiting the dentist for a dental exam in a schedule recommended by the dentist.

According to the CDC, more than 51 million school hours are lost each year nationwide because of dental-related illness, and more than half of children aged five to nine have had at least one cavity or filling, by 78 percent of 17-year-olds having experienced tooth decay.

Anthem provides coverage for most vaccines and exams. However, policyholders should confirm their specific benefits by calling the toll-free number listed on their insurance card.

“We encourage our members to make sure their children start the academy year off on the right foot health-wise by getting the recommended immunizations, and having their eyes and teeth examined,” said Dr. Holmstrom. “These exams are essential for keeping children and teens healthy and helping them to focus on their many activities during the school year.”

Source: Anthem Blue Cross and Blue Shield in Maine

Category: Immune System
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EACAAI, Excellence In Clinical Education, Communication And Patient Care

September 1st, 2010

Be amidst the first to heed the latest research from the terraqueous globe’sitting leading allergists presented at the 2010 annual according to principles meeting of the American College of Allergy, Asthma and Immunology (ACAAI), Nov. 11-16, in Phoenix. The encounter, held at the Phoenix Convention Center, resolution be attended through more than 4,000 physicians, healing personnel and exhibitors in the field of allergy, asthma and immunology.

Media demise be in possession of access to renowned allergist experts and can attend daily press conferences cover topics such as obesity, environment, bed bugs and alternative medicine.

Studies, panels, and courses to be presented include:

— Allergies to lifetime’s pleasures

— What’session new in food allergy New NIAID Guidelines

— Environment assessments

— Complementary and alternative medicine

— Hot topics in pediatric allergy

— Asthma in the obese child

— Preventing nutrition allergy in full risk infants

— Bed bugs and more

— 100 years of Immunotherapy

— Current and future treatments for eye allergies (conjunctivitis)

— Too juvenile to wish nasal allergies

— Exercise induced asthma and allergies

Annual Meeting components take in some 100 according to principles sessions, 40 workshops, 200 technical exhibits and 350 abstract presentations.

Source: American College of Allergy, Asthma and Immunology (ACAAI)

Category: Immune System
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Nerve Repair In Injuries Involves Antibodies

June 13th, 2010

Antibodies – warrior proteins the immune system makes to defend the body against invading pathogens such as viruses and bacteria – be the subject of a gentler lateral nobody knew around until now: They function not solely considered in the state of soldiers but besides as nurses. And researchers at the Stanford University School of Medicine now think antibodies’ absence in the central nervous system (the brain and spinal string) may be a key part of the reason wherefore hardihood injury there doesn’t get naturally repaired in humans. That insight could someday lead to new treatments for stroke and spinal-cord trauma.

In a fair-minded discovered study conducted in mice, to be under the necessity being published online June 14 in Proceedings of the National Academy of Sciences, the Stanford scientists show for the first time that antibodies are critical to the repair of invigorate damage to the peripheral weakly system – nervous woven stuff that extends outside the brain and spinal line, such considered in the state of the ischiadic invigorate, where circulating antibodies have access. The weigh also shows that some, but not all, antibodies get the work at jobs terminated. Harnessing those proteins’ unanticipated nurturing qualities may go before as guide to new ways of repairing damage from misfortune or spinal-cord detriment, at the same opportunity that not amiss.

“Nobody has known for what cause, end nerve cells in the central nervous system fail to renew after injury whereas those in the peripheral nervous plan regenerate robustly,” said senior consideration maker Ben Barres, MD, PhD, professor and chair of neurobiology. So his group was intrigued by one major contest between the pair easily agitated systems: Antibodies, which are copious huge proteins, have limited access to the brain and spinal cord (these organs are surrounded by some interface called the blood-brain barrier or, in the spinal cord, the blood-spinal cord obstacle), while they have expeditious access to the peripheral nervous regularity.

Nerve cells form from one side of to the other electrochemical impulses over long distances by means of long, pipe-like projections called axons. These axons are typically wrapped in an insulating layer of a fat substance called myelin.

“After nerve damage, the degenerating myelin downstream from the injury is quickly cleared in the peripheral, yet not the central, nervous rule,” said Barres. “In circumstance in an injured human brain or spinal cord, the degenerating myelin just sits there for the rest of the person’s lifetime. But after hurt to, say, the ischiatic nerve, the degenerating myelin is cleared within a week or less.”

The two in the beginning authors, Mauricio Vargas, MD, PhD, a forgoing learner in Barres’ lab, and Junryo Watanabe, PhD, a postdoctoral researcher in the lab, wondered whether antibodies to components of degenerating myelin might play a role in that discharge. The researchers obtained mutant laboratory mice that can’confidentially make antibodies, and demonstrated that, in those mice, repair of injury to the sciatic nerve is substantially impeded, as is the removal of degenerating myelin downstream from the prejudice station. Simply injecting the injured mutant mice through antibodies from healthy, uninjured ones restored both myelin removal and sciatic-nerve repair capability in the mice.

While antibodies have been fix to play a role in the ordering of aging red relations cells, this is the first time they’ve been implicated in injury vamp up, related Vargas, now in his internship at White Memorial Medical Center in Los Angeles pending the quick spring of his residency in ophthalmology at UCLA.

What’s greater degree, the investigators threw well leavened on the habit in which this happens. “We showed that antibodies clutch onto degenerating myelin downstream from the site of the nerve damage, coating the myelin and tagging it conducive to clearance by the agency of ravenous immune cells called macrophages,” Vargas uttered.

The word macrophage roughly translates from Greek as “self-conceited eater.” These roving gourmands are especially prone to swallow up antibody-tagged bacteria and diseased cells. “It’s analogous to spreading choice part cheese on a bagel,” said Vargas.

Using various standard laboratory tools, including especial staining techniques, the study’s authors observed that macrophages bring about in point of fact chew up antibody-tagged degenerating myelin downstream from the nerve-injury site. Myelin exoneration in the antibody-lacking mice was substantially enhanced when antibodies from hearty mice were provided.

Surprisingly, it made no difference whether the antibodies came from normal mice that had suffered similar injuries or mice that had suffered none. This suggests that the antibodies binding to degenerating myelin and flagging it despite demolition by squads of macrophages are already present in uninjured mice, rather than summoned into service barely subsequently harm. These “off-the-shelf” natural antibodies save the week or two that it would have taken the dead body to form the more sophisticated, precisely shaped antibodies that are produced in response to a singular viral or bacterial infection.

In one additional experiment, the Barres team injected the injured mice through a dose of each antibody that specifically targets a protein known to come to pass only on myelin. Doing such restored nerve-injury restoration, whereas administering antibodies that harden to targets not associated with myelin didn’t help. This proved that not upright any antibodies, nevertheless in some degree antibodies that associate with degenerating myelin, are the ones that expedite nerve repair in the peripheral spirited system.

It wouldn’t exist advantageous if naturally occurring antibodies were unable to make famous betwixt working and worthless myelin – this could result in debilitating autoimmune disease. But, Barres said, degenerating myelin has structural features on its exterior that are quite unlike from those exposed to the immune system steady the surface of functioning myelin.

Although these findings totality involve the peripheral nervous system, they make an attempt a tantalizing give an inkling of being of the class who to a possible way to influence tinker to damaged nerve cells in the central nervous universe after, say, a stroke or spinal cord injury. “One idea,” said Barres, “would subsist to bypass the blood-brain barrier by delivering anti-degenerating-myelin proteins directly into the spinal liquid. We’re hoping that these antibodies might therefore spread a covering over the myelin, signaling to microglia – macrophages’ counterparts in the central robust system – to patent the degenerating myelin.” That might, in turn, jump-start the new birth of damaged fearful tissue, he added.

“This is absolutely important, elegant work,” said Zhigang He, PhD, associate professor of neurology at Harvard Medical School whose lab focuses on the natural regenerative ability of forceful tissue and who did not take a part in in the study bound is familiar spirit with it. “Everybody’s trying to understand what accounts for the difference between the capacities for repair in the peripheral against the central nervous system. Now we accept a possible mechanism, so we can start to think about some kind of tactics to speed up myelin discharge in the brain.”

The work was supported by the agency of funds from the National Eye Institute, the Adelson Medical Research Foundation, the National Institutes of Health and the National Multiple Sclerosis Society. Other co-authors are Simar Singh, then working on his undergraduate thesis in the Barres lab, and William Robinson, MD, co-operator professor of immunology and rheumatology.

Source:
Bruce Goldman
Stanford University Medical Center

Category: Immune System
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