Why Antibody Lots Differ Significantly

Since antibodies first attained prominence as research reagents in modern biological science labs, researchers have been perplexed as to why one production lot can differ significantly from the next, in terms of performance. Poor antibody performance has caused the loss of countless hours of research, to say nothing of the mental anguish of the researchers themselves. An antigen is a substance that stimulates the production of antibodies.

 http://www.dddmag.com/news/2013/10/why-antibody-lots-differ-significantly?et_cid=3555713&et_rid=523035093&type=cta
fig is Schematic representation of pure and contaminated antibodies carrying histones or histones complexed with DNA. (Source: Biochemistry and Cell Biology)

Sanofi Pasteur Initiates Phase III Study of Investigational Clostridium difficile Vaccine in the United States

Cdiffense trial to evaluate vaccine against a leading cause of life-threatening, healthcare-associated infections worldwide

SWIFTWATER, Pa., Aug. 5, 2013 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. The investigational vaccine is designed to help protect at-risk individuals from C. diff, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwidehttp://www.pharmalive.com/sanofi-starts-phase-iii-trial-for-clostridium-difficile-vaccine

A Tumorigenic Breakdown

The catabolism of branched-chain amino acids promotes the development of brain tumors
Read more

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Study Shows Diets Lacking Omega-3s Lead to Anxiety, Hyperactivity in Teens

Pittsburgh, PA (Scicasts) – Diets lacking omega-3 fatty acids―found in foods like wild fish, eggs, and grass-fed livestock―can have worsened effects over consecutive generations, especially affecting teens, according to a University of Pittsburgh study.

read at
http://scicasts.com/bio/6358-study-shows-diets-lacking-omega-3s-lead-to-anxiety-hyperactivity-in-teens

• amcrasto@gmail.com

  

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The Health Benefits of Ginger

The Health Benefits of Ginger

Warner Chilcott Announces FDA Approval of New Oral Contraceptive

DUBLIN, Ireland, July 25, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (Nasdaq:WCRX) today announced that the United States Food and Drug Administration (FDA) has approved LO MINASTRIN™ FE (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets and ferrous fumarate tablets) for the prevention of pregnancy. The Company is currently developing the commercial launch plans for LO MINASTRIN FE.http://www.pharmalive.com/fda-oks-warner-chilcotts-lo-minastrin-fe

 

 

Scripps Research Institute Scientists Find a Potential Cause of Parkinson’s Disease that Points to a New Therapeutic Strategy

 For a high-resolution image see: http://www.scripps.edu/news/press/
images/reed_steve/reed_steve.jpg
LA JOLLA, CA – July 24, 2013 – Biologists at The Scripps Research Institute (TSRI) have made a significant discovery that could lead to a new therapeutic strategy for Parkinson’s disease.
The findings, recently published online ahead of print in the journal Molecular and Cell Biology, focus on an enzyme known as parkin, whose absence causes an early-onset form of Parkinson’s disease. Precisely how the loss of this enzyme leads to the deaths of neurons has been unclear. But the TSRI researchers showed that parkin’s loss sharply reduces the level of another protein that normally helps protect neurons from stress.
 http://www.scripps.edu/news/press/2013/20130724reed.html

Isis Phase II drug APOIIIRx slashes triglycerides by 64%

Isis Pharmaceuticals is "very encouraged" by a second set of mid-stage data for its heart drugAPOIIIRx, which shows that it can substantially slash levels of dangerous fats in the blood. 

In a 26-patient Phase II trial, patients with severely high levels of triglycerides taking Isis' drug alongside fibrates experienced 64% drop in triglycerides, and a 70% drop in apolipoprotein C-III (apoC-III), a component of 'bad' low-density lipoprotein
read all at
.http://www.pharmatimes.com/Article/13-07-23/Isis_PhII_drug_slashes_triglycerides_by_64.aspx

New therapy for pancreatic cancer: Phase III clinical trial currently recruiting Australian patients

Currently there is a clinical trial that is recruiting patients from around the globe including sites across Australia. The trial is testing MM-398; a therapy that uses the latest in nanotechnology to deliver the chemotherapeutic agent irinotecan encased in a liposome to cancer patients.¹ In particular this trial, named NAPOLI-1 (NAnoliPOsomaL Irinotecan) is recruiting patients with pancreatic cancer who have previously been treated with the chemotherapy agent gemcitabine unsuccessfully i.e. their disease has gone on to spread/progress despite this treatment.<sup>2,3
read all here

http://www.virtualmedicalcentre.com/news/new-therapy-for-pancreatic-cancer-phase-iii-clinical-trial-currently-recruiting-australian-patients/18708</sup>


irinotecan

Irinotecan (Camptosar, Pfizer; Campto, Yakult Honsha) is a drug used for the treatment of cancer.

Irinotecan prevents DNA from unwinding by inhibition of topoisomerase 1. In chemical terms, it is a semisynthetic analogue of the natural alkaloid camptothecin.

Its main use is in colon cancer, in particular, in combination with other chemotherapy agents. This includes the regimen FOLFIRI, which consists of infusional 5-fluorouracil,leucovorin, and irinotecan.

Irinotecan received accelerated approval by the U.S. Food and Drug Administration (FDA) in 1996 and full approval in 1998. During development, it was known as CPT-11.

Irinotecan is activated by hydrolysis to SN-38, an inhibitor of topoisomerase I. This is then inactivated by glucuronidation by uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1). The inhibition of topoisomerase I by the active metabolite SN-38 eventually leads to inhibition of both DNA replication and transcription.

Merrimack currently has six oncology therapeutics in clinical development, multiple product candidates in preclinical development and an active Systems Biology-driven discovery effort. 
MM-398
(Nanotherapeutic)

• Indication:
• Description:
• Target

• Pancreatic Cancer (2^nd line, 2 indications), Colorectal Cancer, Glioma
• Nanotherapeutic
• Encapsulated irinotecan

MM-398 is a nanotherapeutic consisting of the chemotherapuetic irinotecan, encapsulated in a liposomal sphere. MM-398 is designed to rely on the natural blood flow of the tumor to direct the therapy directly to the site of the cancer and minimize exposure to non-target cells.

MM-398 in the Clinic

MM-398 is being evaluated in clinical trials for its ability to treat tumors resistant to chemotherapy across multiple types of cancers, including pancreatic, lung, colorectal and glioma. The FDA and the European Medicines Agency granted MM-398 orphan drug designation in 2011 for the treatment of patients with metastatic pancreatic cancer who have previously failed treatment with the chemotherapy drug gemcitabine. Our Phase 3 study, NAPOLI-1 (NAnoliPOsomaL Irinotecan), is currently underway.
posters
http://merrimackpharma.com/library/research/mm-398-preclinical-posters

Anticancer agent – elacytarabin

Elacytarabine

Cytarabine is a cytosine derivative that is a common component of chemotherapy regimens for blood cancers such as acute myeloid leukaemia (AML), and because it can cross the blood–brain barrier, it is useful in the treatment of central nervous system lymphomas. However, the response is variable, and resistance commonly develops via multiple mechanisms. Its activity is dependent on the intracellular concentrations of the active phosphorylated form, and one of the main mechanisms of resistance involves the deficiency of the transporter molecule hENT1 that carries it into the cells. As a result, Clavis Pharma developed a lipophilic ester derivative, elacytarabine, whose cellular uptake is not hENT1-dependent.1

- See more at:http://www.manufacturingchemist.com/technical/article_page/Anticancer_agent__elacytarabine/83035

 http://www.manufacturingchemist.com/technical/article_page/Anticancer_agent__elacytarabine/83035#sthash.bF8Vqa3M.dpuf

Cancer drug tested in pet dogs is now bound for human trials

PAC 1
Thanks to a new $2 million investment, a drug that spurs cancer cells to self-destruct while sparing healthy cells is on the road to human clinical trials. The compound, known as PAC-1, has so far proven safe and has promising anti-cancer effects in cell culture, in mouse models of cancer and in pet dogs with spontaneously occurring lymphomas and osteosarcomas.

If PAC-1 (pack one) makes it through the U.S. Food and Drug Administration’s Investigational New Drug review, the first human (Phase I) clinical trial of the drug will begin in mid-2014. The investor, who wishes to remain anonymous, has an option to invest another $2 million to take the drug into human trials. The clinical work will be conducted at the University of Illinois Cancer Center in Chicago.

http://news.illinois.edu/news/13/0717cancer_drug_PaulHergenrother_TimFan.html

Photo by
L. Brian Stauffer

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University of Illinois chemistry professor Paul Hergenrother, left, and veterinary clinical medicine professor Tim Fan led a study of an anti-cancer compound in pet dogs that is now headed for human clinical trials.
PAC-1 (first procaspase activating compound) is a synthesized chemical compound that selectively induces apoptosis, or cell suicide, in cancerous cells. PAC-1 has shown good results in mouse models and is being further evaluated for use in humans. In 2010 a published study showed PAC-1 to be safe to research dogs, and a second study published later that same year reported that a PAC-1 derivative (called S-PAC-1) was well tolerated in a small Phase I Clinical Trial of pet dogs with lymphoma. Even at low doses of S-PAC-1, tumors regressed in 1/6 dogs, and the disease was stabilized (no additional tumor growth) in 3/6 dogs

Alkermes Adds Multiple Sclerosis Pill To Expanding Pipeline

Alkermes Adds Multiple Sclerosis Pill To Expanding PipelineTheStreet.comThe company expects to seek permission from FDA to begin human testing of its MMF prodrugs for multiple sclerosis in 2014, with a phase I study slated to begin mid-year. Composition of matter patents have been filed, which if granted, would give the ...

read all at
http://www.thestreet.com/story/11981784/1/alkermes-adds-multiple-sclerosis-pill-to-expanding-pipeline.html?cm_ven=GOOGLEN

Santarus Completes Patient Enrollment in CONTRIBUTE Study with UCERIS (budesonide) as Add-on Treatment to 5-ASA Drugs

Santarus Completes Patient Enrollment in CONTRIBUTE Study with UCERIS ...MarketWatchA Biologics License Application for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema is under review by the U.S. Food and Drug Administration with a response expected in April 2014. Santarus is also ...

read all at


http://www.marketwatch.com/story/santarus-completes-patient-enrollment-in-contribute-study-with-uceris-budesonide-as-add-on-treatment-to-5-asa-drugs-2013-07-18

SAN DIEGO, Jul 18, 2013 (BUSINESS WIRE) -- Santarus, Inc. /quotes/zigman/91852/quotes/nls/snts SNTS -0.61% today announced the completion of enrollment in the CONTRIBUTE clinical study designed to evaluate the incremental benefit of adding UCERIS(R) (budesonide) extended release 9 mg tablets to oral aminosalicylate (5-ASA) therapy for the induction of clinical remission in adult patients with active, mild to moderate ulcerative colitis. UCERIS is currently approved in the U.S. for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Sanofi starts dengue vaccine production for 2015 launch

Sanofi Pasteur is poised to produce the first validation batches of their dengue vaccine at the company’s state-of-the-art production centre near Lyon, France.

According to Antoine Quin, manager at the site in Neuville-sur-Saone, the plant has a design capacity of 100 million doses of the vaccine, tetravalent CYD-TDV, annually. Starting around 2015, Sanofi Pasteur expects to manufacture one billion doses over the following decade.

Investing 300 million euros in building and staffing the plant was a substantial gamble for Sanofi, said Guillaume Leroy, dengue vaccine head. The Lyon facility got the green light in 2009, when only Phase II data was available. Although promising, this was far from definitive........................

read all at

http://www.pharmatimes.com/Article/13-07-15/Sanofi_starts_dengue_vaccine_production_for_2015_launch.aspx

more on dengue

Dengue Fever Prevention

Neither vaccine nor drugs for preventing infection are available. The bite of one infected mosquito can result in infection. The risk of being bitten is highest during the early morning, several hours after daybreak, and in the late afternoon before sunset. However, mosquitoes may feed at any time during the day. Aedes mosquitoes typically live indoors and are often found in dark, cool places such as in closets, under beds, behind curtains, and in bathrooms. Travelers should be advised to use insecticides to get rid of mosquitoes in these areas and to select accommodations with well-screened windows or air conditioning when possible. Additionally, travelers should take measures to avoid being bitten by mosquitoes. Long-term travelers and expatriates can take extra precautions to reduce mosquito-breeding sites around their accommodations by emptying and cleaning or covering any standing water (such as in water storage tanks and flowerpot trays).

SOURCE: CDC

Dengue fever facts

• Dengue fever is a disease caused by a family of viruses that are transmitted by mosquitoes.
• Symptoms such as headache, fever, exhaustion, severe joint and muscle pain, swollen glands (lymphadenopathy), and rash. The presence (the "dengue triad") of fever, rash, and headache (and other pains) is particularly characteristic of dengue fever.
• Dengue is prevalent throughout the tropics and subtropics. Outbreaks have occurred recently in the Caribbean, including Puerto Rico, the U.S. Virgin Islands, Cuba, and in Paraguay in South America, and Costa Rica in Central America.
• Because dengue fever is caused by a virus, there is no specific medicine or antibiotic to treat it. For typical dengue fever, the treatment is purely concerned with relief of the symptoms (symptomatic).
• The acute phase of the illness with fever and myalgias lasts about one to two weeks.
• Dengue hemorrhagic fever (DHF) is a specific syndrome that tends to affect children under 10 years of age. It causes abdominal pain, hemorrhage (bleeding), and circulatory collapse (shock).
• The prevention of dengue fever requires control or eradication of the mosquitoes carrying the virus that causes dengue.
• There is currently no vaccine available for dengue fever.

What is dengue fever?

Dengue (pronounced DENG-gay) can affect anyone but tends to be more severe in people with compromised immune systems. Because it is caused by one of four serotypes of virus, it is possible to get dengue fever multiple times. However, an attack of dengue produces immunity for a lifetime to that particular serotype to which the patient was exposed.Dengue fever is a disease caused by a family of viruses that are transmitted by mosquitoes. It is an acute illness of sudden onset that usually follows a benign course with symptoms such as headache,fever, exhaustion, severe muscle and joint pain, swollen glands(lymphadenopathy), and rash. The presence (the "dengue triad") of fever,rash, and headache (and other pains) is particularly characteristic of dengue. Other signs of dengue fever include bleeding gums, severe pain behind the eyes, and red palms and soles.

Dengue goes by other names, including "breakbone" or "dandy fever." Victims of dengue often have contortions due to the intense joint andmuscle pain, hence the name breakbone fever. Slaves in the West Indies who contracted dengue were said to have dandy fever because of their postures and gait.

Dengue hemorrhagic fever is a more severe form of the viral illness. Symptoms include headache, fever, rash, and evidence of hemorrhage in the body. Petechiae (small red or purple splotches or blisters under the skin), bleeding in the nose or gums, black stools, or easy bruising are all possible signs of hemorrhage. This form of dengue fever can be life-threatening and can progress to the most severe form of the illness, dengue shock syndrome.

PROSTRATE CANCER

ALLOW SLIDESHARE TO LOAD...........................

Prostate cancer from morwenna2

Vical's Allovectin Phase III Trial Results: Consider The Possibilities

Vical's Allovectin Phase III Trial Results: Consider The Possibilities ... Cohen: We saw that happen last year when JNJ prematurely unblinded the pre- chemo Phase III study for the prostate cancer drug Zytiga. The trial achieved ... http://seekingalpha.com/article/1538852-vical-s-allovectin-phase-iii-trial-results-consider-the-possibilities Allovectin-7 is a substance that is being studied as a gene therapy agent in the treatment of cancer, such as malignant melanoma. It is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin - two components of major histocompatibility complex (MHC, class I). It increases the ability of the immune system to recognize cancer cells and kill them. In 1999, FDA granted Allovectin-7 orphan drug designation for the treatment of invasive and metastatic melanoma. Allovectin-7 entry in the public domain NCI Dictionary of Cancer Terms

Ohr Pharmaceutical Achieves 50% Enrollment Milestone in Squalamine Eye Drop Phase II Clinical Trial

squalamine

July 10, 2013 /
Ohr Pharmaceutical, Inc. , a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that it has enrolled the first 60 patients in the Company's ongoing OHR-002 Phase II clinical trial evaluating Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration ("wet-AMD").
The study is a randomized, double blind, placebo controlled study enrolling patients at more than twenty clinical sites in the U.S. "We are excited to have reached the halfway point in the enrollment of our Squalamine Eye Drop study," said Dr. Irach B. Taraporewala, CEO of Ohr.
"This milestone sets the stage for the planned interim analysis once the 60 patients complete the nine month treatment protocol, and we expect the data to be available in the second quarter of 2014.
" "I am pleased with the continued progress in the trial to evaluate Squalamine Eye Drops for exudative AMD," commented Dr. Jason Slakter, retinal disease specialist at Vitreous-Retina-Macula Consultants of NY, and member of Ohr's scientific advisory board. "The Company's eye drop for treating wet-AMD would potentially offer patients a convenient, self-administered, treatment alternative or adjunct to currently used intravitreal injections directly into the eye. This could be a significant advancement in the future treatment of wet-AMD." Study OHR-002 is a randomized, double blind, placebo controlled Phase II study to evaluate the efficacy and safety of Squalamine Eye Drops for the treatment of wet-AMD.
The study will enroll 120 treatment naive wet-AMD patients at more than twenty clinical sites in the U.S., who will be treated with Squalamine Eye Drops or placebo eye drops twice daily for a nine month period.
The primary and secondary endpoints include visual acuity parameters, need for rescue intravitreal injections, and safety. The protocol includes an interim analysis upon the completion of the treatment period in 50% of the patients (60). More information on the clinical trial can be found at clinicaltrials.gov. About Ohr Pharmaceutical, Inc. Ohr Pharmaceutical, Inc. (NasdaqCM:OHRP) is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The Company is focused on advancing its pipeline products currently in phase II clinical development: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia. Additional information on the Company can be found at www.ohrpharmaceutical.com.