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Phase3 Ganetespib, a Unique Triazolone-Containing Hsp90 Inhibitor, Exhibits Potent Antitumor Activity and a Superior Safety Profile for Cancer Therapy
Chemical structure of ganetespib and its co-crystal structure with Hsp90 N-terminal.
A, chemical structure of ganetespib.
B, crystallographic complex of ganetespib in the Hsp90 N-terminal.
C, hydrogen bond interactions between ganetespib with amino acid residues in the Hsp90 N-terminal ATP-binding pocket.
Synta Pharmaceuticals has opened a ClinicalTrials.gov listing for their much discussed GALAXY-2 phase 3 trial of their HSP90 inhibitor ganetespib in second-line non-small cell lung cancer (NSCLC), in combination with docetaxel. For the moment at least, the phase 2b GALAXY-1 trial is still listed as enrolling patients, but that would be expected to complete soon.
http://clinicaltrials.gov/ct2/show/NCT01798485
- CAS Number:
- 888216-25-9
-
3H-1,2,4-Triazol-3-one, 5-[2,4-dihydroxy-5-(1-methylethyl)phenyl]-2,4-dihydro-4-(1-methyl-1H-indol-5-yl)-
- Ganetespib
- Molecular Structure:
![Molecular Structure of 888216-25-9 (3H-1,2,4-Triazol-3-one, 5-[2,4-dihydroxy-5-(1-methylethyl)phenyl]-2,4-dihydro-4-(1-methyl-1H-indol-5-yl)-)](https://i0.wp.com/www.lookchem.com/300w/2012-2/e100939d-148c-4f54-9b7c-83632fb0d675.gif)
- Formula: C20H20N4O3
![Molecular Structure of 888216-25-9 (3H-1,2,4-Triazol-3-one, 5-[2,4-dihydroxy-5-(1-methylethyl)phenyl]-2,4-dihydro-4-(1-methyl-1H-indol-5-yl)-)](http://www.lookchem.com/300w/2012-2/e100939d-148c-4f54-9b7c-83632fb0d675.gif)
Hsp90, a chaperone essential for the folding of JAK2, is the target of Synta Pharmaceuticals’ ganetespib.
HSP70i, A genetically modified protein, on Experimental Vitiligo Treatment, Shows Promise in Mice
WEDNESDAY Feb. 27, 2013 — A genetically modified protein could provide the first effective treatment for the skin condition vitiligo, a new study in mice suggests.
People with vitiligo have white patches on the face, hands and other parts of the body. Vitiligo is an autoimmune disorder in which the immune system becomes overactive and kills the pigment cells that give skin its color.
Researchers at the Loyola University Chicago Stritch School of Medicine developed a genetically modified protein that reversed vitiligo in mice and had similar effects on human skin tissue samples. Findings from animal studies do not always hold up in human trials, however.
A protein called HSP70i plays a major role in the autoimmune response that causes vitiligo. The researchers genetically modified an amino acid in the protein in order to create a mutant version of HSP70i. This version replaces normal HSP70i and reverses the autoimmune response that causes vitiligo, the study authors explained in a Loyola news release.
When the mutant HSP70i was given to mice with vitiligo, their salt-and-pepper fur turned black, giving them a normal appearance. The mutant protein had a similar effect on human skin samples, according to the study, published in the current issue of the journal Science Translational Medicine.
Researcher I. Caroline Le Poole, a professor in Loyola’s Oncology Institute, and colleagues are seeking approval and funding to conduct a clinical trial of the modified protein in humans.
About 1 million Americans have vitiligo, which affects about one in 200 people worldwide. There are no long-term effective treatments for the condition. Current options include steroid creams, light therapy and skin grafts, but none of them can prevent vitiligo from progressing.
More information
The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about vitiligo.
AstraZeneca ready to file constipation drug naloxegol
4,5α-epoxy-6α-[(3,6,9,12,15,18,21-heptaoxadocosan-1-yl)oxy]-17-(prop-2-en-1-yl)morphinan-3,14-diol
Naloxegol (INN; NKTR-118), or PEGylated naloxol,[1] is a peripherally-selective opioid antagonist under development by AstraZeneca (licensed from Nektar) for the treatment of opioid-induced constipation.[2]
- Roland Seifert; Thomas Wieland; Raimund Mannhold; Hugo Kubinyi, Gerd Folkers (17 July 2006). G Protein-Coupled Receptors as Drug Targets: Analysis of Activation and Constitutive Activity. John Wiley & Sons. p. 227. ISBN 978-3-527-60695-5. Retrieved 14 May 2012.
- “Nektar | R&D Pipeline | Products in Development | CNS/Pain | Oral Naloxegol (NKTR-118) and Oral NKTR-119”. Retrieved 2012-05-14.
phase3
AstraZeneca has presented positive data from a late-stage trial of naloxegol in patients with non-cancer related pain and opioid-induced constipation.
In the fourth trial in a Phase III development programme designed to evaluate long-term safety and adverse event profile , 534 patients received naloxegol once-daily for up to 52 weeks, while 270 were on usual care (laxatives) for OIC. The most commonly-reported AEs occurring more frequently on naloxegol than on usual care included abdominal pain, diarrhoea, nausea and headache but the trial reported no imbalances in serious adverse events.
Briggs Morrison, head of the global medicines development at AstraZeneca, said “these high-level results are similar to the safety results seen in the Phase III studies previously reported and provide further confidence in the data we’ve seen to date for naloxegol”. The programme is now complete and filings in the USA and Europe are planned for the third quarter.
Globally, some 40–50% (28-35 million) of patients taking opioids for long-term pain develop constipation and about 40–50% (11-18 million) of those OIC sufferers achieve the desired outcomes with current options, ie laxatives.
The actual timing of the submissions depend in part on a meeting with the US Food and Drug Administration as naloxegol is currently considered a Schedule II controlled substance across the Atlantic based on its “structural relatedness” to noroxymorphone. AstraZeneca says it has conducted the studies necessary to evaluate the abuse potential and dependence-producing properties of naloxegol and a petition to de-control the drug was submitted in March 2012.
Naloxegol, a peripherally-acting mu-opioid receptor antagonist and formerly known as NKTR-118, was licensed from Nektar Therapeutics in September 2009.
FDA Approves Osphena,Ospemifene for Postmenopausal Women Experiencing Dyspareunia
Ospemifene
CAS Number: 128607-22-7
Molecular Formula: C24H23ClO2
Molecular Weight: 378.89 g.mol-1
February 26, 2013 — The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Dyspareunia is a condition associated with declining levels of estrogen hormones during menopause. Less estrogen can make vaginal tissues thinner, drier and more fragile, resulting in pain during sexual intercourse.
Osphena, a pill taken with food once daily, acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in the amount of pain women experience with sexual intercourse.
“Dyspareunia is among the problems most frequently reported by postmenopausal women,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Osphena provides an additional treatment option for women seeking relief.”
Osphena’s safety and effectiveness were established in three clinical studies of 1,889 postmenopausal women with symptoms of vulvar and vaginal atrophy. Women were randomly assigned to receive Osphena or a placebo. After 12 weeks of treatment, results from the first two trials showed a statistically significant improvement of dyspareunia in Osphena-treated women compared with women receiving placebo. Results from the third study support Osphena’s long-term safety in treating dyspareunia.
Common side effects reported during clinical trials included hot flush/flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating.
Osphena is marketed by Florham Park, N.J.-based Shionogi, Inc.
- Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy – May 9, 2012
Immune begins Phase II study of ulcerative colitis drug, Bertilimumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | CCL11 (eotaxin-1) |
phase 2 NCT01671956; C2a/BRT/UC-01
A Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Clinical Efficacy, and Pharmacokinetic Profile of Bertilimumab in Subjects With Active Moderate to Severe Ulcerative Colitis
25 February 2013
Immune Pharmaceuticals has started Phase II study of its bertilimumab (iCo-008 or CAT-213) drug, designed for the treatment of moderate-to-severe ulcerative colitis.
Bertilimumab is a human immunoglobulin monoclonal antibody which targets eotaxin-1, a member of the chemokine family of proteins regulating eosinophilic inflammation.
The double-blind, parallel group, randomized, placebo-controlled 90 patients-based study is designed to demonstrate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis.
60 patients in the study will be treated with bertilimumab 7mg/kg, while 30 patients with placebo every two weeks at days 0, 14, and 28, according to the company.
In addition, the patients will be evaluated for clinical response after six weeks to determine the decrease if any in the full Mayo Clinic Ulcerative Colitis Score.
Secondary and exploratory end points of the study include clinical remission defined as symptom free, fecal calprotectin, a recognized marker of gastro-intestinal inflammation, histopathology improvement and degree of mucosal injury.
The company, which is expecting to follow-up the patients for up to day 90, said the patient enrollment and clinical results are likely to be completed in 2014.
The company has also announced that bertilimumab will be the lead clinical stage development drug for the combined company following completion of the proposed merger with EpiCept in the second quarter of 2013.
Bertilimumab is a human monoclonal antibody that binds to eotaxin-1, an important regulator of overall eosinophil function.
patent WO00166754
It was discovered by Cambridge Antibody Technology using their phage displaytechnology.[1] Named CAT-213 during early discovery and development by CAT, it was to be used to treat severe allergic disorders.[2]
In January 2007, CAT licensed the drug for treatment of allergy disorders to iCo Therapeutics Inc.[3] iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications – a so-called ‘search and development company’.[4]
iCo Therapeutics Inc. renamed the drug from CAT-213 to iCo-008 and, at that stage, planned to initiate a Phase II clinical trial in patients with vernal keratoconjunctivitis.[5]
In March 2008, iCo announced iCo-008 had been in 126 patients in Phase I and II clinical trials. The drug substance had been manufactured by Lonza, in its cGMP facilities inSlough, UK. Subsequently iCo moved the drug substance to a fill-finish site for the final stage of manufacturing. iCo reported that the iCo-008 drug product was within specifications and contained a high antibody yield.[6]
In June 2011, IMMUNE Pharmaceuticals[7] (Herzliya, Israel) in-licensed Bertilimumab from iCo for non-ophthalmic indications. [8]IMMUNE is initiating Phase II clinical trials of Bertilimumab in inflammatory bowel disease (ulcerative colitis & Crohn’s disease) in 2012 and 2013.
- http://jpet.aspetjournals.org/cgi/content/abstract/319/3/1395
- Bertilimumab Cambridge Antibody Technology Group. 5. November 2004. pp. 1213–8. PMID 15573873.
- http://www.icotherapeutics.com/site/investor-relations/cambridge_antibody_tech_licenses_monoclonal_antibody_treatment_allergy/
- http://www.icotherapeutics.com/site/corporate_overview/overview/
- http://www.icotherapeutics.com/site/pipeline/ico008/
- http://www.icotherapeutics.com/site/investor-relations/ico_therapeutics_provides_ico_008_phase_ii_clinical_update/
- http://immunepharmaceuticals.com/
- http://immunepharmaceuticals.com/index.php?option=com_content&view=article&id=32&Itemid=20
…………………………………….
DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,
Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.
Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.
His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs
He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published worldwide .
He has good proficiency in Technology Transfer, Spectroscopy , Stereochemistry , Synthesis, Reactions in Org Chem , Polymorphism, Pharmaceuticals , Medicinal chemistry , Organic chemistry literature , Patent related site , Green chemistry , Reagents , R & D , Molecules , Heterocyclic chem , Sourcing etc
He suffered a paralytic stroke in dec 2007 and is bound to a wheelchair, this seems to have injected feul in him to help chemists around the world, he is more active than before and is pushing boundaries, he has one lakh connections on all networking sites, He makes himself available to all, contact him on +91 9323115463, amcrasto@gmail.com
FDA Approves Generic Suboxone, Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets
SUBOXONE (buprenorphine and naloxone) sublingual film is an orange film, imprinted with a logo identifying the product and strength in white ink. It contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in four dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone, 4 mg buprenorphine with 1 mg naloxone, 8 mg buprenorphine with 2 mg naloxone, and 12 mg buprenorphine with 3 mg naloxone . Each sublingual film also contains polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, FD&C yellow #6, and white ink.
Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy-6α,14-ethano14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure:
 |
Buprenorphine HCl has the molecular formula C29H41NO4 • HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.
Chemically, naloxone HCl dihydrate is 17-Allyl-4,5 α -epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure:
 |
Naloxone hydrochloride dihydrate has the molecular formula C19H21NO4 • HCl • 2H 20 and the molecular weight is 399.87. It is a white to slightly off-white powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether.
Feb. 25, 2013 — The United States Food and Drug Administration (FDA) has approved generic versions of Reckitt Benckiser Healthcare’s Suboxone sublingual tablets. Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg will be produced by two U.S. based generic manufacturers – Actavis, Inc. and Amneal Pharmaceuticals, LLC.
Suboxone is indicated for maintenance treatment of opioid dependence.
For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data. The generic equivalents are expected to save millions in healthcare costs.
buprenorphine
Chemical Name: (2S)-2-[(-)-(5R,6R,7R,14S)-9α-cyclopropylmethyl-4,5-epoxy-6,14-ethano-3-hydroxy-6-methoxymorphinan-7-yl]-3,3-dimethylbutan-2-ol
Uses: Pain, Opiate/Opioid Abuse Treatment
Routes: Sublingual
Half-Life (H½): 37 Hours
Bioavailability: ~50-60% (Sublingual Tablet)
Protein Binding: 96%
Potency: 30-50x (Oral Morphine)
State Food and Drug Administration, China Grants Approval to Sihuan Pharmaceutical for Clinical Trial of Innovative Drug — Pinoxacin Hydrochloride
HONG KONG, Feb. 22, 2013, Sihuan Pharmaceutical Holdings Group Ltd. a leading pharmaceutical company with the largest cardio-cerebral vascular (“CCV”) drug franchise in China’s prescription market, today announced that Pinoxacin Hydrochloride, a Category 1.1 new drug developed by the Company’s innovative drug research and development team, received Approval for Clinical Studies from the State Food and Drug Administration. Phase I of clinical studies are set to begin in the first half of this year. It is the fourth Category 1 innovative drug for which the Company has received Approval for Clinical Studies.
Pinoxacin Hydrochloride is DPP-4 inhibitor class of oral hypoglycemic agents, a drug with a brand new structure for treating type II diabetes. It is clinically used to enhance the function of endogenous insulin for improving glycemic control, and long-term use can improve islet beta-cells function. Pre-clinical research has shown that DPP-4 inhibitors have potent in vitro and in vivo activities, a good selection profile, great stability and controllable quality, as well as better tolerance, with long-term administration showing a protective effect on pancreatic beta-cells. In addition, the DPP-4 inhibitor will not cause serious side effects such as weight gain and hypoglycaemia seen in traditional diabetes drugs. Pinoxacin Hydrochloride has good pharmacokinetic characteristics, high oral bioavailability, quick absorption, rapid onset and a longer duration. A once daily dosage is expected to keep the patients’ symptoms under control. The advantages of Pinoxacin Hydrochloride have proven the drug’s growth potential present in the market.
FDA Approves Stivarga, Regorafenib for Advanced Gastrointestinal Stromal Tumors
Regorafenib
cas 755037-03-7
4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide hydrate
February 25, 2013 — The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.
GIST is a tumor in which cancerous cells form in the tissues of the gastrointestinal tract, part of the body’s digestive system. According to the National Cancer Institute, an estimated 3,300 to 6,000 new cases of GIST occur yearly in the United States, most often in older adults.
Stivarga, a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or has spread to other parts of the body (metastatic) and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other FDA-approved drugs to treat GIST.
“Stivarga is the third drug approved by the FDA to treat gastrointestinal stromal tumors,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It provides an important new treatment option for patients with GIST in which other approved drugs are no longer effective.”
Stivarga was approved in September 2012 to treat colorectal cancer. It is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J. Gleevec is marketed by East Hanover, N.J.-based Novartis, and Sutent is marketed by New York City-based Pfizer.
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase (RTK). Regorafenib shows anti-angiogenic activity due to its dual targetedVEGFR2-TIE2 tyrosine kinase inhibition. It is currently being studied as a potential treatment option in multiple tumor types.[1]
Metastatic colorectal cancer
Regorafenib demonstrated to increase the overall survival of patients with metastaticcolorectal cancer[2] and has been approved by the US FDA on September 27, 2012.[3]Stivarga is being approved with a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).[4]
- “Bayer Announces New Data on Oncology Portfolio To Be Presented at the ECCO-ESMO Congress 2009”. Retrieved 2009-09-19.
- “Phase III Trial of Regorafenib in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival”. Retrieved 2011-10-26.
- “FDA approves new treatment for advanced colorectal cancer”. 27 Sep 2012.
- “FDA Prescribing Information”. 27 Sept 2012.
UC Riverside’s Michael Pirrung announces development of TIR-199 for renal (kidney) cancer at conference in Dubai
The compound TIR-199 that holds much promise in the laboratory in fighting renal (kidney) cancer. feb19,2013
RIVERSIDE, Calif. — Chemists at the University of California, Riverside have developed a compound that holds much promise in the laboratory in fighting renal (kidney) cancer.
Named TIR-199, the compound targets the “proteasome,” a cellular complex in kidney cancer cells, similar to the way the drug bortezomib, approved by the Food and Drug Administration, targets and inhibits the proteasome in multiple myeloma cells, a cancer coming from bone marrow.
Michael Pirrung, a distinguished professor of chemistry at UC Riverside, announced the development of TIR-199 in a lecture he gave on Feb. 19 at the 5th International Conference on Drug Discovery and Therapy, held in Dubai, UAE.
Operating like the garbage dump of a cell, the proteasome breaks down proteins. Drugs that block the action of proteasomes are called proteasome inhibitors, and have been shown to have activity against a variety of cancer cell lines, albeit with mixed results. For example, bortezomib, though effective against multiple myeloma, has many side effects because cells other than bone marrow cells are affected.
“The novel feature of our new proteasome inhibitor, TIR-199, is that it is nearly as potent as bortezomib, but is selective in inhibiting the growth of only renal cancer cell lines,” Pirrung said. “It’s what makes TIR-199 attractive.”
The TIR-199 research project at UC Riverside began about four years ago after a multidisciplinary, international team reported on a class of compounds that act on the proteasome. These compounds are the “syringolin” natural products — such as a compound produced naturally by the wheat-infecting bacterium Pseudomonas syringae. TIR-199 is a synthetic relative of syringolin.
Michael Pirrung is a distinguished professor of chemistry at UC Riverside. Photo credit: I. Pittalwala, UC Riverside.
Structure of Syringolin A.
The ring structure of syringolin A is formed by the two nonproteinogenic amino acids 5-methyl-4-amino-2-hexenoic acid and 3,4-dehydrolysine. The α-amino group of the latter is joined by a peptide bond to a valine residue, which is linked to another valine residue via a urea moiety.
Researchers Begin Shigella Vaccine Trial , WRSs2 and WRSs3
FEB2013
PHASE 1 Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines WRSs2 and WRSs3
Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Enroll serial groups up to 90 subjects. Evaluate safety and tolerance of WRSs2 by monitoring presence and severity of clinical signs and symptoms, evaluate the immune response in blood and stool following ingestion of WRSs2
http://clinicaltrials.gov/show/NCT01336699
Shigellosis is one of those nasty bacterial diseases that follows the cringeworthy fecal-oral route to infect humans and other primates. Mild cases bring stomachaches; the severe end includes cramping, vomiting, fever, diarrhea, and it generally only gets more disgusting from there. While the disease can occur all over the world—estimates suggest ninety million cases of Shigellosis dysentery each year—the greatest mortality occurs in the third world. Hoping to stem transmission, or, at least, minimize the damage it causes, the World Health Organization has long called for a vaccine to stop Shigella infection.
And, today, scientists are one step closer. The National Institutes of Health announced that two Shigella vaccine have entered early-stage human clinical trials:
Researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children. The Phase 1 clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States.
Researchers have launched an early-stage human clinical trial of two related candidate vaccines to prevent infection with Shigella, bacteria that are a significant cause of diarrheal illness, particularly among children. The Phase I clinical trial, funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will evaluate the vaccines for safety and their ability to induce immune responses among 90 healthy adults ages 18 to 45 years. The trial is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the eight NIAID-funded Vaccine and Treatment Evaluation Units in the United States ….
…. Led by principal investigator Robert W. Frenck, Jr., M.D., director of clinical medicine at Cincinnati Children’s, the new clinical trial will evaluate two related candidate vaccines, known as WRSs2 and WRSs3, which have been found to be safe and effective when tested in guinea pigs and nonhuman primates. Both target Shigella sonnei, one of the bacteria’s four subtypes and the cause of most shigellosis outbreaks in developed and newly industrialized countries. Though neither candidate vaccine has been tested in humans, a precursor to both, known as WRSs1, was found to be safe and generated an immune response in small human trials in the United States and Israel. This early work was supported by NIAID, the U.S. Department of Defense and the Walter Reed Army Institute of Research. All three versions of the vaccine were developed by researchers at the Walter Reed institute.
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 