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New MR Technique May Help Save Women From Unnecessary Breast Biopsies

A new MR procedure that uses diffusion-weighted imaging (DWI) to determine whether or not a breast lesion is malignant or benign may help reduce unnecessary breast biopsies, according to a study performed at the National Institute of Health in Bethesda, MD. DWI is a method that produces images detecting the exchange of water molecules between tissue compartments (diffusion). The study included 80 patients with 85 lesions.

Novel Leukemia Vaccine For High-Risk Patients Studied At Moores UCSD Cancer Center

Researchers at the Moores Cancer Center at the University of California, San Diego (UCSD) are conducting clinical trials of a novel therapy aimed at revving up the immune system to combat a particularly difficult-to-treat form of leukemia. The experimental therapy is being offered to patients with chronic lymphocytic leukemia (CLL) whose cancer did not respond or was resistant to initial treatment or harbors a particular chromosomal abnormality called a 17p deletion.

Lancet Publishes 48 Week Phase III Data For 'Isentress'® (Raltegravir) In Previously Untreated (Treatment-NaĂŻve) HIV-Infected Patients

The online edition of The Lancet has published results from a forty-eight week Phase III study of previously untreated (treatment-naĂŻve) HIV-infected patients which showed that 'Isentress'® (raltegravir), Merck Sharp & Dohme Limited's (MSD) first-in-class integrase inhibitor, was found to be as effective as efavirenz at suppressing viral load to undetectable levels (less than 50 copies/mL) when used in combination therapy.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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First Patient Dosed In Phase 2 Clinical Trial Of NKTR-102 In Ovarian Cancer

Nektar Therapeutics (Nasdaq: NKTR) announced today that dosing has started in a Phase 2 clinical trial of NKTR-102 in platinum-resistant ovarian cancer. Regulatory approvals have also been obtained and dosing will begin shortly in two additional trials: a randomized Phase 2 study to evaluate NKTR-102 versus irinotecan in second-line colorectal cancer patients with the KRAS gene mutation, and a Phase 2 study in metastatic breast cancer.

Sucampo Completes Enrollment In Its Phase 2 Trial Of Cobiprostone For The Prevention Of NSAID-Induced Ulcers

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) an international biopharmaceutical company, announced that its wholly owned subsidiary, Sucampo Pharma Americas, Inc., has completed enrollment of its phase 2 clinical trial of cobiprostone designed to evaluate the compound's efficacy and safety for the prevention of ulcers and other gastrointestinal injuries in arthritis patients treated with non-steroidal anti-inflammatory drugs (NSAID).

ThromboGenics To Present Results Of Second Phase III Trial Of Microplasmin At The 28th Annual Meeting Of The American Society Of Retina Specialists

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, announces that data from the second Phase III trial of microplasmin (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA), are to be presented at the 28th Annual Meeting of the American Society of Retina S...

Compliance in Developing countries is a balancing act

Clinproxy’s, www.clinproxy.com global spread continues to acknowledge to issues with regards to developing countries and the compliance required for clinical trials. Compliance is a balancing act between home-country regulations, international guidelines, and local rules and customs. ...
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First Patient Treated In Phase II Trial Of Anticancer Hsp90 Inhibitor

The Institute of Cancer Research (ICR) is to receive a milestone payment triggered by the first patient receiving a drug it helped develop in a Phase II clinical trial. The drug, an Hsp90 inhibitor known as AUY-922, is being tested in a range of cancers. It works by targeting and inactivating a crucial molecule called Hsp90, which cancer cells are dependant on for growth...

The Benefits And Risks Of Preventative Brain Radiation For Lung Cancer Patients

A new study is taking a closer look at the benefits versus risks for lung cancer patients to undergo preventative brain radiation therapy as a means to stop cancer from spreading to the brain. Study results show that while preventative brain radiation for patients with non-small cell lung cancer - the most common form of lung cancer - does reduce the chance of developing brain metastases, it impacts some short-term and long-term memory.

Scientific Data Relating To Cinryze(TM) (C1 Esterase Inhibitor [Human]) Presented At International Congress Of The Southern European Allergy Society

ViroPharma Incorporated (Nasdaq: VPHM) announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy. Cinryze was approved by the U.S...

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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New Approach Uses A Common Virus To Combat Deadly Lung Cancer

Among the 5,000 studies being discussed by 30,000 oncologists at the 2008 meeting of the American Society of Clinical Oncology (ASCO), a great deal of buzz was generated over the discovery that a substantial subset of patients with non-small cell lung cancer (NSCLC) may not benefit from the most commonly prescribed therapies. About 20% of the more than 180,000 NSCLC patients diagnosed every year in the U.S. have mutations in the K-RAS gene.

Individuals Who Apply Pesticides Are Found To Have Double The Risk Of Blood Disorder

A study involving 678 individuals who apply pesticides, culled from a U.S. Agricultural Health Study of over 50,000 farmers, recently found that exposure to certain pesticides doubles one's risk of developing an abnormal blood condition called MGUS (monoclonal gammopathy of undetermined significance) compared with individuals in the general population.

Torax Medical Launches Pivotal Clinical Study Of New Acid Reflux Treatment

Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastroesophageal reflux disease (GERD) has commenced a pivotal clinical trial of its LINX(TM) Reflux Management System. The trial, which is being conducted at 15 leading academic and private medical centers in the U.S. and Europe, will evaluate the safety and effectiveness of the LINX System in patients suffering from GERD despite medical therapy.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
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Genzyme And Isis Announce That Mipomersen Phase 3 Study In Patients With Homozygous Familial Hypercholesterolemia Met Primary Endpoint

Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) today announced that the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) met its primary endpoint, with a 25 percent reduction in LDL cholesterol after 26 weeks of treatment, vs. 3 percent for placebo (p

GTx Announces Investigational OstarineT (MK-2866) Met The Primary Endpoint In Phase II Cancer Cachexia Clinical Trial - Cancer Induced Muscle Lo

GTx, Inc. (NASDAQ: GTXI) today announced topline results of a Phase II clinical trial evaluating OstarineT (MK-2866), an investigational selective androgen receptor modulator (SARM), in patients with cancer induced muscle loss, also known as cancer cachexia. In this analysis, the study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo and the secondary endpoint of muscle function (performance) after 16 weeks of treatment.

Omrix Biopharmaceuticals Initiates Phase II Clinical Trial In Israel For Fibrin Pad Product Candidate

Omrix Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI) announced that it has enrolled its first patient in a Phase II clinical trial in Israel for its Fibrin Pad product candidate. This is the first clinical trial that will evaluate the Fibrin Pad's performance in surgery where severe bleeding is present and the product is applied directly onto a solid organ. The Phase II clinical trial in Israel is being conducted simultaneously with the Phase II clinical trial in the U.S.

Anestvice Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery

Anestvice ( www.anestvice.com )Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery. During the surgery pressure in the cuff may fluctuate, thereby endangering the patient. Currently ...
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High Response Rate Experienced By Multiple Myeloma Patients Treated With New 3-Drug Combination

A new three-drug combination has shown in a phase 1/2 clinical trial that it is a "highly effective regimen" in the treatment of patients newly diagnosed with multiple myeloma, a cancer of white blood cells in bone marrow, say researchers from Dana-Farber Cancer Institute...

SwabCap Improves Disinfection Allowing For A Reduction In Catheter-Related Bloodstream Infections, First Major Clinical Trial Concludes

Early results of a prospective, peer-reviewed clinical trial demonstrated SwabCap® reduced central-line associated bloodstream infection (CLABSI) rates by more than 79% in a four-hospital system according to a scientific poster presented at the recent meeting of the Society for Healthcare Epidemiology of America (SHEA)...

Medtronic Completes Enrollment Ahead Of Schedule In Key Trial Of Endeavor(R) Resolute Drug-Eluting Stent

Medtronic, Inc. (NYSE: MDT), announced today that enrollment in the 2,300-patient RESOLUTE All-Comers (R-AC) clinical study was completed in just six months, two months ahead of schedule. The randomized trial compares the safety and efficacy of Medtronic's Endeavor Resolute drug-eluting stent (DES) with Abbott Laboratories' Xience® DES.

Pharmalef Developments is a home for team-oriented professionals

Pharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.They entered into many collaborations with leading ...
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Subchondral Bone Changes Contribute To Cartilage Damage And Loss

A recent study determined that bone area predicted the development of medial (inner side) and lateral (outer side) knee cartilage damage and loss of medial cartilage volume. Subchondral bone mineral density (BMD) was associated with medial defect development but not cartilage loss...

Exercise Keeps Dangerous Visceral Fat Away A Year After Weight Loss

A study conducted by exercise physiologists in the University of Alabama at Birmingham (UAB) Department of Human Studies finds that as little as 80 minutes a week of aerobic or resistance training helps not only to prevent weight gain, but also to inhibit a regain of harmful visceral fat one year after weight loss. The study was published online Oct. 8 and will appear in a future print edition of the journal Obesity.

New Study Findings Could Help Millions Who Suffer From Dry Mouth

A newly developed time-released muco-adhesive patch for treating oral health conditions, including the widespread condition of dry mouth (xerostomia), has been shown to be more effective than a leading oral rinse, according to a newly-published study...

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity. In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities ...
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Passive Smoking Linked To Chronic Sinus Disease Risk (Chronic Rhinosinusitis)

People who are exposed to the smoke of other smokers - secondhand smoke - in private or public settings appear to have a higher-than-normal risk of developing chronic rhinosinusitis (chronic sinus disease), , according to a study published in the April issue of Archives of Otolaryngology-Head & Neck Surgery, one of the JAMA/Archives journals...

VEGF Trap-Eye Final Phase 2 Results In Age-related Macular Degeneration Presented At 2008 Retina Society Meeting

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size, for up to one year in a Phase 2 study in the neovascular form of Age-related Macular Degeneration (wet AMD).

St. Jude Medical Announces Publication Of Feasibility Results For Trial Of Novel Heart Failure Management System

St. Jude Medical, Inc. (NYSE:STJ) announced publication of clinical results in the Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) trial...

Outsourcing is not a new concept to pharmaceutical companies

Outsourcing is not a new concept to pharmaceutical companies; however, its use increased dramatically in the mid-1990s, and it is expected to continue to increase going forward. It is estimated by 2004 nearly 42% of all pharmaceutical drug development expenditures will be committed to ...
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Catalyst Pharmaceutical Partners, Inc. Begins Enrollment For U.S. Phase II Clinical Trial Of CPP-109 In Patients With Methamphetamine Addiction

Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company that acquires or in-licenses, develops and commercializes prescription drugs for the treatment of drug addiction and obsessive compulsive disorders, announced that it has begun enrollment for its randomized, double-blind, placebo-controlled U.S. Phase II clinical trial evaluating CPP-109 for the treatment of patients addicted to methamphetamine.

Two-Year SYNTAX Data Show Comparable Safety Outcomes For Complex Patients Treated With TAXUS(R) EXPRESS(R) Stents And Bypass Surgery

Boston Scientific Corporation (NYSE: BSX) announced two-year data from its SYNTAX clinical trial comparing percutaneous coronary intervention (PCI) using the TAXUS(®) Express(®) Paclitaxel-Eluting Coronary Stent System to coronary artery bypass graft (CABG) surgery. The overall results demonstrated no statistically significant difference between PCI and CABG in the composite safety endpoint (all-cause death, stroke and myocardial infarction [MI]).

Isis Initiates Phase 1 Clinical Trial Of SGLT2 Antisense Drug

Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced it has initiated a Phase 1 study of ISIS-SGLT2Rx, an antisense drug that inhibits the production of sodium dependent glucose co-transporter type 2 (SGLT2). SGLT2 is the major transporter responsible for glucose re-absorption in the kidney. Decreasing SGLT2 levels promotes glucose excretion in the urine and reduces blood sugar levels, making it an attractive target for the treatment of diabetes.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
(613) 686-5745 Cerepotec Pharmalef

The Results Are In: Users Of BodyMedia's Wearable Body-Monitoring Technology Lose 3 Times More Weight

With obesity in America reaching alarming levels -- across our adult and youth populations -- results from a clinical trial unveiled by BodyMedia confirm that participants who used BodyMedia's wearable body-monitoring technology either in conjunction with a group weight loss program or as part of their own self-directed program lost up to three times more weight than individual...

InSite Vision Commences Phase 1/2 Clinical Study Of ISV-303 For Post-Surgical Ocular Pain And Swelling

InSite Vision Incorporated (OTCBB:INSV), a company developing novel ophthalmic therapeutics, announced the initiation of a Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation associated with ocular surgery...

Johns Hopkins University And Axela Enter Into Cardiac Research Agreement

Researchers from the Johns Hopkins University School of Medicine have entered into an agreement with Axela Inc. to use dotLab® technology in a clinical trial that evaluates circulating cardiac Troponin complexes (cTn) directly in patient samples. Dr. Jennifer Van Eyk, Director of the Johns Hopkins NHLBI Proteomics Center (JHNBPC) in Baltimore, U.S.A., is the lead researcher for this trial.

Clinproxy believes in the concept that cooperation with other CROs is the key to unlocking great accomplishments in the biopharmaceutical research industry.

Clinproxy is a Contract Research Organization www.clinproxy.com that is attempting to change the idea that has overwhelmed the Biopharmaceutical Industry, that for a company to survive it had to exist in competition with all others.Clinproxy, on the other hand has embraced the ...
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New Clinical Study Shows Patients With Type 2 Diabetes May Be Able To Tolerate Higher Doses Of Metformin Using GLUMETZA

Depomed, Inc. (NASDAQ:DEPO) and Santarus, Inc. (NASDAQ:SNTS) announced new data suggesting that patients previously intolerant of metformin may be able to tolerate higher doses of metformin when treated with GLUMETZA® (metformin HCl extended release tablets)...

Biothera Initiates Dosing In A Phase III Trial In Colorectal Cancer Patients

Biothera began dosing patients today in a Phase III trial evaluating Imprime PGG® in combination with cetuximab (Erbitux®) as a potential new treatment for recurrent or progressive KRAS wild-type colorectal cancer. The trial design is built on data obtained in the company's previous clinical studies in colorectal cancer...

New Start For Clinical Trials For Medical Devices

The Medical devices sector is currently one of the fastest growing areas within life sciences, experiencing growth of around 11% between 2010 and 2011. However, development in this sector is broadly influenced by the strict regulation, which is continually evolving ...

Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.

Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of ...
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Alzheimer's Society Comment On National Trial Of New Personal Health Budgets

These trials will answer some of the important questions raised by personal health budgets. 'Potentially they could increase care and treatment options available to people with dementia. They may also lead to better joint working between health and social care if multidisciplinary teams are involved in planning.

New Vaccine Trial Planned Using Weakened Malaria Parasites

Using live but weakened malaria parasites as the basis of a vaccine represents a potentially encouraging anti-malaria strategy, according to results of follow-up animal studies performed after the conclusion of a recent clinical trial in humans...

Cytheris Announces Publication Of Preclinical Study Showing Combination Of Interleukin-7 With Viral Vaccine Boosts Immunity To Tumors

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced publication of data showing that following a vaccine- induced immune response, adjuvant interleukin-7 (IL-7) improves anti-tumor responses and survival in an animal model. The study was conducted by an international team of researchers at the Campbell Family Institute for Breast Cancer Research, University Health Network, Toronto, Canada.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each progression through its development has been predicated upon safe, sound, efficient ...
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Alimera Announces Positive Results From The Two Phase 3 FAME(TM) Trials Of Iluvien(R) In Patients With Diabetic Macular Edema

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported top-line results from the month 24 readout of the FAME Study...

New Pill To Treat Multiple Sclerosis

A new drug for multiple sclerosis can dramatically reduce the chances of a relapse or a deterioration of the condition, according to a new study from researchers at Queen Mary, University of London. The results of a major trial presented at the Annual Meeting of the American Academy of Neurology in Seattle show that taking a course of cladribine tablets just a few times a year can reduce the chances of a relapse by well over 50 per cent.

Lack Of Sleep Could Be More Dangerous For Women Than Men

Women who get less than the recommended eight hours sleep a night are at higher risk of heart disease and heart-related problems than men with the same sleeping patterns. Research by the University of Warwick and University College London has found that levels of inflammatory markers vary significantly with sleep duration in women, but not men.

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
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RegeneRx Completes Enrollment And Dosing Of Phase IA Safety Trial For Potential Heart Drug - First Injectable Use Of RGN-352 Tested In Humans

Regenerx Biopharmaceuticals, Inc. announced today that it has completed enrollment and dosing of 40 healthy subjects for its Phase IA clinical trial testing RGN-352, an injectable formulation of Tβ4 for potential use in treating acute myocardial infarction patients (AMI or heart attack). The trial includes four groups of ten subjects each to assess the safety of escalating doses of RGN-352 injected into the blood stream. To date, there have been no significant drug-related adverse events.

Cancer-Causing Virus Associated With Higher Risk Of New HIV Infection

Infection with anal human papillomavirus (HPV), a virus that can cause anal and cervical cancers, is associated with a higher risk of new HIV infection in previously HIV-negative men who have sex with men (MSM), according to new UCSF research. Reported online ahead of print in the journal AIDS, the findings are available now. They are scheduled for publication in an upcoming print issue.

OncoMed Anti-Cancer Stem Cell Antibody OMP-21M18 Demonstrates Potent Activity In Preclinical Studies Against Human Colon Cancer Tumors

OncoMed Pharmaceuticals, Inc., a company developing novel therapeutics that target cancer stem cells, announced the publication of preclinical data demonstrating that its lead candidate, OMP-21M18, inhibits tumor growth and reduces cancer stem cell frequency when administered alone or in combination with chemotherapy in human colorectal cancer tumors with or without KRAS mutations...

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
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Study Finds Financial Ties Between Clinical Study Leaders And Pharmaceutical Companies

Reuters reports that a new study has found "cancer researchers who design clinical trials, analyze or interpret the data, or play other key scientific roles are four times more likely to have financial ties to industry than their counterparts who have lesser roles in these studies, such as recruiting study subjects or collecting the data...

Research Misconduct Revealed in UK

A BMJ survey revealed that over one in ten (13%) UK based scientists or doctors have witnessed that colleagues intentionally changed or fabricated data during their research in order to get published, whilst 6% of respondents reported they are aware of possible research misconduct at their institution, that has not been accurately investigated...

Biomodels' Oral Mucositis Expertise Speeds FDA Approval For ActoGeniX's Phase 1b Trial Of AGO13 In Cancer Patients

Biomodels LLC, a preclinical research organization specializing in cancer support care, announced that its customized research program allowed ActoGeniX NV, a development stage biopharmaceutical company, to rapidly attain Food and Drug Administration (FDA) approval for Phase 1b clinical trials of AGO13 in cancer patients with oral mucositis.

Pharmalef Developments plays a vital role in proper documenting the drug development process.

New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By ...
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Relapse In Early Breast Cancer Patients Following Endocrine Therapy, Prediced By New Model

Researchers have developed and validated a model that predicts relapse in women with stage 2 or 3 breast cancer who have been treated with endocrine therapy prior to surgical removal of the tumor, according to a study published online September 23 in the Journal of the National Cancer Institute. The preoperative endocrine prognostic index (PEPI) may help identify women who can safely avoid chemotherapy and those women at high risk of relapse who should be considered for aggressive therapy.

SLaM Trialling New OCD Treatments For Young People, UK

SLaM's Obsessive Compulsive Disorder Service for children and adolescents is currently running two innovative trials to help improve the treatment of young people with obsessive compulsive disorder (OCD)...

Sucampo Reports Top-Line Results Of Phase 2 Clinical Trial Of Cobiprostone For Prevention Of NSAID-Induced Gastrointestinal Injuries

Sucampo Pharma Americas, Inc., a wholly owned subsidiary of Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), today reported top-line results from its phase 2 clinical trial of orally administered cobiprostone for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). A total of 124 patients with osteoarthritis and/or rheumatoid arthritis at 12 sites in the U.S.

Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).

Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a ...
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Celsion Announces ThermoDox's Prominence In Abstracts Presented At The 2nd International MR-Guided Ultrasound Symposium

Celsion Corporation (Nasdaq: CLSN) announced that two abstracts on the ThermoDox® High Intensity Focused Ultrasound (HIFU) development program have been delivered via oral presentation at the MR-guided Focused Ultrasound 2010 2nd International Symposium...

BioLineRx Announces First Subject Enrolled In Phase I Clinical Trial Of BL-1021 For Neuropathic Pain

BioLineRx (TASE:BLRX) announced today the enrollment of the first subject in a Phase I study of BL-1021, an orally available small molecule for treating neuropathic pain. This clinical trial will be a first-in-human, single-site, double-blind, placebo controlled study to assess safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers...


Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.


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