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Data From Phase 1 Study Confirm High Response Rate Of Micromet's Blinatumomab In Patients With Non Hodgkins Lymphoma

Micromet, Inc...

SCOLR Pharma Announces Completion Of Patient Enrollment And Dosing For Pivotal Clinical Trial Evaluating Extended Release Ibuprofen

SCOLR Pharma, Inc. (Amex: DDD) announced the completion of patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The Company expects to report top-line results from this pivotal trial in November 2008.

Study Suggests Memory Repression May Help The Traumatized

Geisinger Health System senior investigator and U.S. Army veteran Joseph Boscarino, Ph.D., is proud of his military service, yet he doesn't like to talk much about his combat experiences. Before becoming a renowned researcher of psychological trauma, Dr. Boscarino served a tour of duty with an artillery unit in Vietnam from 1965-66, during which he witnessed heavy combat and its aftermath. To this day, he tries hard not to reflect on those battlefield memories.

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to ...
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Clinical Trial Data Documenting Improved Menopause Symptoms

SE5-OH containing Natural S-equol, a novel soy germ-based ingredient in a supplement, improved menopausal symptoms, including significantly reducing hot flash frequency by nearly 59 percent, according to a peer-reviewed study in Japanese women. This key study was presented in an oral presentation at the North American Menopause Society (NAMS) 20th annual meeting.

Psychological Interventions Associated With Breast Cancer Survival

A new study finds that breast cancer patients who participate in intervention sessions focusing on improving mood, coping effectively, and altering health behaviors live longer than patients who do not receive such psychological support.

FDA Approves ADCIRCA(TM) (Tadalafil) Tablets For The Treatment Of Pulmonary Arterial Hypertension

United Therapeutics Corporation (Nasdaq: UTHR) announced that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH).

Clinproxy: In general the overall expense of clinical trials depends on a multitude of factors

In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. The overall cost of clinical trials ...
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Inspire Completes Patient Enrollment In Three Late-Stage Clinical Trials In Cystic Fibrosis, Dry Eye And Blepharitis

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today patient enrollment is complete in three of its late-stage clinical trials. "We are pleased to be executing on our strategic plan with the achievement of these patient enrollment milestones in the clinical development programs for denufosol, PROLACRIA™ and AZASITE®, as this places us in a position to have top-line results from all our late-stage clinical programs within 18 months.

TAXUS OLYMPIA Registry Shows Excellent Outcomes For High-Risk Patients Treated With Second-Generation TAXUS(R) Liberte(R) Stent

Boston Scientific Corporation (NYSE: BSX) announced positive one-year results from the Intercontinental and European launch phases of its global TAXUS OLYMPIA registry, the world's largest prospective, post-approval registry for a single drug-eluting stent (DES).

High Blood Pressure Is Related To Depression In Elderly Subjects

An epidemiological study performed in Spain discloses a relationship between high blood pressure and depression in the elderly in the current issue of Psychotherapy and Psychosomatics. A positive association between hypertension and depression has been reported in some inquiries but not in others, and the relationship was limited to individuals with diastolic blood pressure (DBP) in some studies.

Clinproxy: In general the overall expense of clinical trials depends on a multitude of factors

In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. The overall cost of clinical trials ...
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Cancer Patients Want Honesty, Compassion From Their Oncologist

What do patients want from their radiation oncologists? The most significant preference is that more than one-third of female cancer patients (37 percent) prefer to have their hands held by their radiation oncologists during important office visits, compared to 12 percent of men, according to a randomized study presented November 4, 2009, at the 51st Annual Meeting of the American Society for Radiation Oncology (ASTRO).

The Medicines Company Discontinues Phase 3 CHAMPION Clinical Trial Program Of Cangrelor

The Medicines Company (NASDAQ: MDCO) announced that it is discontinuing its Phase 3 CHAMPION clinical trial program of cangrelor in patients undergoing percutaneous coronary intervention (PCI).

CEO Roundtable On Cancer Offers "Common Language" To Jump Start Cancer Clinical Trials

Potentially life-lengthening cancer therapies could enter clinical trials and ultimately reach cancer patients dramatically faster thanks to legal contract language created by the CEO Roundtable on Cancer, a nonprofit group of cancer-fighting CEOs. The group hopes to shorten the drug testing process by making available "common language" for clinical trial contracts through a set of standardized contract templates for use by NCI-designated cancer centers and the pharmaceutical industry.

What Clinical Research Is All About

How can researchers prove to the government that a newly-discovered drug or device is safe and effective? This is where the clinical trial comes in. The clinical trial is a research study designed to determine if a new pharmaceutical or medical device is sufficiently safe and effective for ...
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Cancer Treatment Centers Of America(R) Studies Treatment That Aims Chemotherapy Directly At Ovarian Cancer Cells

Cancer Treatment Centers of America (CTCA) at Midwestern Regional Medical Center, a leading provider of innovative cancer care for patients living with complex and advanced-stage disease, is the only hospital in Illinois and Wisconsin to take part in new clinical research involving a treatment designed to target ovarian cancer cells otherwise resistant to standard chemotherapy.

Flexible Stenting Solutions, Inc. Receives Conditional IDE Approval For FlexStent(R) Femoropopliteal Self Expanding Stent System

Flexible Stenting Solutions Inc. ("FSS"), a leading developer of next generation peripheral arterial and biliary stents, announced that it has received Conditional Investigational Device Exemption (IDE) approval for its FlexStent® Femoropopliteal Self Expanding Stent System. With this approval, FSS is initially authorized to begin its US clinical trial at up to 10 clinical sites and 50 patients. FSS expects to address FDA conditions within the next 45 days.

FDA Approves Boston Scientific's Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System

Boston Scientific Corporation (NYSE: BSX) announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System, a highly deliverable, next-generation drug-eluting stent (DES) specifically designed for treating small coronary vessels. It was approved for use in vessels as small as 2.

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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Investigational Factor Xa Compound: Data Presented At European Heart Meeting

Data from a Phase II study of an investigational drug designed to block formation of blood clots show potential for added protection against a second heart attack or stroke among patients who are already taking state-of-the-art prevention therapy, according to researchers at the Duke Clinical Research Institute.

Phase I Clinical Trial Of A Preventive AIDS Vaccine Shows Encouraging Outcome

A second Phase I AIDS vaccine clinical trial in India was successfully completed, the Indian Council of Medical Research, the National AIDS Control Organization and the International AIDS Vaccine Initiative have announced. The results of the trial of an MVA-based AIDS vaccine candidate (TBC-M4), which was conducted in Chennai, indicated that the vaccine candidate had acceptable levels of safety and was well tolerated.

Hope For 14 Million Rosacea Sufferers: Pyratine-XR(TM) Study To Be Presented At South Beach Symposium

Senetek PLC (OTC Bulletin Board: SNKTY), a life sciences company engaged in the development of technologies that target the science of healthy aging, announced that positive study results from a clinical trial of Pyratine-XR(TM) in patients with rosacea will be presented February 13, 2009, at the 7th Annual South Beach Clinical Dermatology Symposium in Miami, Florida. Dr. Mark Nestor, the Symposium chair, will be presenting "Cytokinins: Cutaneous Aging and Rosacea" at 4:45 PM.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the ...
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New Scientific Review Shows That Zolmitriptan ('Zomig(TM)') Nasal Spray Provided Efficacious Relief From Cluster Headache

Results from a new pooled data analysis presented at the European Headache and Migraine Trust International Congress (EHMTIC) 2008 today show that zolmitriptan ('Zomig') nasal spray provided fast and efficacious relief in the treatment of episodic and chronic cluster headache.

Going Beyond Individual Trials To Compare Drugs

In many disease areas patients are now fortunate enough to be faced with multiple treatment options. However, clinical trials often only tell us how individual treatments perform compared to placebo or one alternative treatment. This raises the question 'How do we choose between treatments that have not been compared in a clinical trial?'. A recent study published in Value in Health addresses this problem for non-small cell lung cancer treatments.

Accumetrics, Inc. Announces 1000th Patient Enrolled In GRAVITAS Trial

Accumetrics, Inc. announces that it has enrolled its 1,000th patient into its landmark clinical trial, GRAVITAS (Gauging Responsiveness with A VerifyNow(R) Assay Impact on Thrombosis And Safety). The trial is specifically designed to demonstrate the value of providing clinicians with actionable information for patients who are poor responders to clopidogrel (Plavix(R)).

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
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Millennium Initiates Phase II Trial For Diffuse Large B-Cell Lymphoma

Millennium: The Takeda Oncology Company today announced the initiation of a Phase II clinical trial examining rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) with or without VELCADE® (bortezomib) for Injection for patients with a common type of lymphoma. The study will examine previously untreated patients with a genomically defined subtype of lymphoma called non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma.

Cancer Drug Is No Different In Effectiveness As Gold Standard Treatment For Macular Degeneration

Investigators from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have shown, at 6 months in a small group of patients, that there is no difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD).

Preventing A Recurrence Of The Northwick Park Trial

Scientists investigating the 2006 Northwick Park drug-trial disaster that left six healthy volunteers hospitalised say they have developed new pre-clinical tests that could have stopped the trial from ever going ahead. But Dr Stephen Poole, speaking at the British Pharmacological Society's Winter Meeting in Brighton, said that research is still "ongoing" to understand why the drug had such an adverse effect in the clinic but not in pre-clinical testing.

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

From what many of our students have said, Kriger www.kriger.com and their professional development courses are not only inspiring but also indispensable when trying to start a career in the biopharmaceutical and clinical research industry. These courses provide the necessary detailed ...
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New Study Reveals Handwriting Is Real Problem For Children With Autism

Handwriting skills are crucial for success in school, communication, and building children's self-esteem. The first study to examine handwriting quality in children with autism spectrum disorders (ASD) has uncovered a relationship between fine motor control and poor quality of handwriting in children with ASD, according to research published in the November 10, 2009, issue of Neurology®, the medical journal of the American Academy of Neurology.

Addex Completes Enrollment Of First Mid-Stage Clinical GERD Trial

Addex Pharmaceuticals (SWISS: ADXN), the allosteric modulation company, announced the completion of enrollment in the Phase IIb trial of ADX10059 as a monotherapy in patients with gastroesophageal reflux disease (GERD), the cause of heartburn and other symptoms. ADX10059 is a first-in-class reflux inhibitor that works by reducing activation of the metabotropic glutamate receptor 5 (mGluR5) through negative allosteric modulation (NAM).

Investigational Cancer Drug BSI-201 Showed Clinical Benefit In 62% Of Patients With Triple-Negative Metastatic Breast Cancer

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its fully owned subsidiary, BiPar Sciences, today announced results from a randomized Phase 2 clinical trial of BSI-201, a poly ADP-ribose polymerase (PARP) inhibitor, in combination with gemcitabine and carboplatin (GC) chemotherapy, in patients with metastatic triple-negative breast cancer (TNBC). BSI-201 is a novel investigational agent that acts by inhibiting PARP1, an enzyme that repairs DNA damage.

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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Two Day Treatment Of Auditory Hallucinations By High Frequency RTMS Guided By Cerebral Imaging: A 6 Months Follow-up Study

Auditory hallucinations are one of the more disturbing features of schizophrenia, and tend to persist even when patients are treated with conventional medication treatments. Researchers from the University of Caen, France, report on a new treatment for hallucinations at the meeting of the Organization for Human Brain Mapping. They used a technique called Repetitive Transcranial Magnetic Stimulation- rTMS, which sends magnetic pulses at high frequency (20 Hz) over the brain surface.

NicOx Announces Results For TPI 1020 In COPD

NicOx S.A. (NYSE Euronext Paris: COX) announced the results of a phase 2a study for TPI 1020, conducted in 62 patients with Chronic Obstructive Pulmonary Disease (COPD) by its partner Topigen Pharmaceuticals Inc. TPI 1020 showed good overall safety and tolerability, although its activity profile was not significantly different from budesonide, a conventional corticosteroid commonly used in respiratory disorders.

Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application For Phase IIb Clinical Trial With MPI-676 In Endometriosis

Meditrina Pharmaceuticals, Inc. announced the approval of its second investigational new drug (IND) application for a Phase IIb dose ranging clinical trial to study MPI-676, the Company's aromatase inhibitor (AI), in combination with estrogen and progestin for the treatment of endometriosis.

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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Treatment For Chronic Hepatitis C: A Phase II Study

The current standard treatment for chronic hepatitis C with pegylated-interferon (PEG-IFN) and ribavirin is effective in approximately 50%-60% of patients, so that a substantial proportion of patients remain unresponsive...

Automated 'Artificial Pancreas' Controls Blood Glucose Levels In Diabetes Patients For First Time

UC Santa Barbara and Sansum Diabetes Research Institute scientists have demonstrated for the first time that an automated artificial pancreas system (APS) can safely and effectively maintain desired blood glucose levels in patients with type 1 diabetes. The clinical study results will be presented today in a late-breaking poster session(1) at the American Diabetes Association's 69th Scientific Sessions in New Orleans.

Possible Association Between High Levels Of Uric Acid And Hypertension

Reducing levels of uric acid in blood lowered blood pressure to normal in most teens in a study designed to investigate a possible link between blood pressure and the chemical, a waste product of the body's normal metabolism, said researchers at Baylor College of Medicine in a report that appears in the current issue of the Journal of the American Medical Association. "If you reduce uric acid, at least in some patients, you may be able to reduce blood pressure," said Dr.

Biopharmaceutical companies focus their attention on outsourcing

In the world of clinical trails it is crucial that the process in which a product goes through the testing and regulatory process be swift at the same time remaining within the budget.This expedited process is achieved when pharmaceutical companies make the decision to outsource ...
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PROLOR Biotech Reports Positive Results From Comparative Study Of Its Longer-Acting Version Of Multiple Sclerosis Drug Interferon Beta In Primates

PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH) reported positive results from a comparative study in primates of its longer-acting version of the multiple sclerosis drug interferon beta (IFN-beta-1a-CTP, referred to as IFN-beta-CTP)...

Men With Prostate Cancer Worry Less About Recurrence Than Their Spouses Do

Researchers at The Mount Sinai Medical Center in New York have found that, when it comes to worrying about the recurrence of prostate cancer, male patients worry less than their female spouses or partners. The study was presented at the 30th annual meeting of the Society of Behavioral Medicine in Montreal. In a study of 96 men and their spouses or partners, Michael Diefenbach, Ph.D.

New Data From Head-to-head Phase 3 Trial Demonstrate That Liraglutide Is More Effective Than Exenatide In Treatment Of Type 2 Diabetes

Today, at the Canadian Diabetes Association Congress, physicians will get a first-time look at more detailed results from a phase 3b clinical study (LEADT 6) comparing the investigational new drug liraglutide to exenatide. The study showed that liraglutide, a human GLP-1 analogue administered once daily, was significantly more effective at improving glycaemic control (as measured by HbA1c) than exenatide, a GLP-1 mimetic administered twice daily.

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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Pharmacyclics Announces Completion Of Phase 1 Clinical Trial Of Factor VIIa Inhibitor PCI-27483

Pharmacyclics, Inc. (Nasdaq: PCYC) announced that the company has completed a Phase 1 clinical trial with PCI-27483, the company's novel, first-in-class small-molecule Factor VIIa inhibitor. The trial was conducted in sixteen (16) healthy volunteers to evaluate the safety and pharmacologic effect of PCI-27483.

New Data Show Duloxetine Maintained Pain Reduction For More Than Six Months In Patients With Diabetic Peripheral Neuropathic Pain

Duloxetine hydrochloride maintained pain reduction in the treatment of diabetic peripheral neuropathic pain (DPNP) for more than six months,[i] according to new data presented today at the 12th World Congress on Pain in Glasgow, Scotland. The open-label study, which aimed to evaluate long-term maintenance of effect of duloxetine 60 mg once daily, is the first to assess the efficacy of duloxetine in DPNP beyond three months.

Successful Phase I/II Clinical Trial For BiondVax Pharmaceuticals' Universal Flu Vaccine

BiondVax Pharmaceuticals Ltd. (TASE: BNDK), an Israeli biopharmaceutical company at the forefront of the development of a Universal Influenza Vaccine, announced the success of the Phase I/II clinical trial of the Company's Multimeric-001 Universal Flu Vaccine, in trials conducted at the Sourasky Medical Center in Tel Aviv, Israel...

Clinproxy: In general the overall expense of clinical trials depends on a multitude of factors

In an ever growing global market of supply and demand, it remains unimaginable to engage in practices that are ambitiously expensive when there are endless opportunities to utilize more appropriately priced methods which would in turn yield the same results. The overall cost of clinical trials ...
(613) 686-5745 Cerepotec Pharmalef

Homeopathy: New Evidence

Two new studies conclude that a review which claimed that homeopathy is just a placebo, published in The Lancet, was seriously flawed. George Lewith, Professor of Health Research at Southampton University comments: 'The review gave no indication of which trials were analysed nor of the various vital assumptions made about the data. This is not usual scientific practice.

Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Of Picoplatin In Small Cell Lung Cancer Did Not Meet Primary Endpoint

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089. "We are disappointed that the trial did not meet the primary endpoint.

Acupuncture Effective For Headaches, But 'Faked' Treatments Work Almost As Well

Headache sufferers can benefit from acupuncture, even though how and where acupuncture needles are inserted may not be important. Two separate systematic reviews by Cochrane Researchers show that acupuncture is an effective treatment for prevention of headaches and migraines. But the results also suggest that faked procedures, in which needles are incorrectly inserted, can be just as effective.

US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril Derivatives

Cereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. This company is also developing a family of other promising novel chemical compounds. Proof of efficacy of these compounds has been obtained in ...
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Can-Fite BioPharma To Initiate Phase II Clinical Trial With CF101 For The Treatment Of Glaucoma

Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced on December 13 the initiation of the regulatory process for a Glaucoma Phase II clinical study in Israel. Leading Medical Centers in Israel will enroll 44 patients with Ocular Hypertension or Glaucoma for the first segment of the trial, who will be treated for 16 weeks with CF101 or placebo...

ACADIA And Biovail Announce Completion Of Enrollment In First Pivotal Phase III Trial With Pimavanserin In Patients With Parkinson's Disease Psychosis

ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) and Biovail Corporation (NYSE:BVF) (TSX:BVF), announced the completion of enrollment in the first pivotal Phase III clinical trial of pimavanserin in patients with Parkinson's disease psychosis (PDP). Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.

FDA Approves Additional Indication For Norditropin(R) For Small For Gestational Age (SGA) In Children

Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] injection) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years. The U.S. Food and Drug Administration (FDA) approved Norditropin(R) based on data from a 13-year clinical trial in children SGA.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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Addex ADX10059 Monotherapy Is Effective On GERD Symptoms In Phase IIb Clinical Trial

Addex Pharmaceuticals (SWISS: ADXN), the allosteric modulation company, announced that it achieved statistically significant efficacy on the primary endpoint, increasing the number of symptom free days in the Phase IIb trial of ADX10059 as a monotherapy in patients with gastroesophageal reflux disease (GERD), the cause of heartburn and other symptoms.

Regulus Therapeutics And Collaborators Publish New Data On A Critical Role For MiR-21 In Brain Tumors

Regulus Therapeutics LLC, a joint venture between Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) formed to discover, develop, and commercialize microRNA-based therapeutics, announced the publication of new research in the journal Molecular and Cellular Biology on the role of the microRNA known as miR-21 in regulating certain cancer cells (1).

Quantum Immunologics Achieves Major Funding In Support Of Ongoing FDA Trials

Quantum Immunologics, Inc. (QI), a Tampa, Florida company focusing on the research and development of cancer immunotherapies, is pleased to announce that it is receiving equity funding from Mentor Capital, Inc. (PINKSHEETS: MNTR) to support its FDA authorized Phase I/II trials on metastatic breast cancer, which are now underway (NCT00879489).

The World Is Getting Better!

According to Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization, the world is getting better, no matter what critics say. Today’s life expectancy is the highest in human history. In Western countries, we ...
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Use Of Prophylactic Acetaminophen (Paracetamol) In Children Receiving Vaccinations Can Reduce Vaccine Response

After receiving immunizations, fever is part of the body's normal inflammatory process. In many cases, acetaminophen (paracetamol) is administered to relieve possible risk of high fever or febrile convulsions in children after routine infant vaccinations. An article in this week's edition of The Lancet reports that prophylactic acetaminophen does indeed reduce post-vaccination fever. However, it also reduces the child's response to some of the vaccine antigens.

Biolex Therapeutics Announces Completion Of Enrollment In SELECT-2 Phase 2b Trial Of Locteron(R) In Chronic Hepatitis C

Biolex Therapeutics, Inc. announced that it has completed patient enrollment in the SELECT-2 Phase 2b trial of its lead product candidate Locteron® for the treatment of chronic hepatitis C. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects, including flu-like symptoms, associated with pegylated interferons, the current standard of care.


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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