The National Institutes of Health (NIH) announced an expanded ClinicalTrials.gov database. The database will accept basic results information, in addition to trial registrations. Due to growing public interest and a desire for improved access to clinical trial information and greater transparency in clinical research, Congress enacted Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85, section 801). In response to this new legislative mandate, those responsible for conducting clinical trials will submit data after the trial is completed. The enhanced database will provide summary results statistics for a broad range of trials of drugs, medical devices and biological products that have been approved by the Food and Drug Administration. Patient-identifiable information will not be included.

“Providing scientists, physicians, and the public with results information could go a long way toward improving safety,” said Director Elias Zerhouni, M.D.

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers specific scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Since 2000, ClinicalTrials.gov, the largest single registry of clinical trials, has provided patients, families and members of the public with easy access to information about a trial’s purpose, who may participate, locations, and phone numbers for more details. This Web site currently has information on nearly 62,000 ongoing and completed trials sponsored by the U.S. Federal government, pharmaceutical industry, academic, and international organizations with locations in all 50 States and in 157 countries.

“In time, the results database will be a powerful tool for researchers and health care consumers alike, and will have untold benefits for the public health too.” said Donald A.B. Lindberg, M.D., Director of the NIH’s National Library of Medicine which developed and administers the new results database.

Results information will be integrated into the clinical trial records that can be reached at http://clinicaltrials.gov/, and through its consumer health information service, MedlinePlus, at http://medlineplus.gov. MedlinePlus has extensive links to information about 750 diseases and health conditions, much of it from the NIH Institutes and Centers.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

Located in Bethesda, Md., the National Library of Medicine is the world’s largest library of the health sciences. For more information, visit the Web site at http://www.nlm.nih.gov.

*Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85, section 801) enacted on September 27, 2007, expanded the scope of trials and information required to be submitted to Clinical Trials.gov and required the submission of results data. This system builds on the existing ClinicalTrials.gov Protocol Registration System and allows sponsors and principal investigators to clinical trials to submit “basic results” summary data necessary to satisfy statutory requirements. Submission will be publicly posted on ClinicalTrials.gov

National Institutes of Health

ImmunoVaccine Technologies’ DepoVax(TM) Shows Positive Results For Cancer And Infectious Diseases

ImmunoVaccine Technologies’ (IVT) patented depot vaccine formulation, DepoVax(TM) is showing positive pre-clinical results, with single-dose efficacy achieved in therapeutic cancer and several infectious disease vaccine models. The results of this research will be presented October 4th at the Ehrlich II conference in Germany. Collaborators from the University of Miami will also be reporting on the capabilities of IVT’s depot formulations for delivery of DNA and SiRNA in vivo.

DepoVax(TM) provides a unique single-dose capability, and is based on a novel approach to the use of liposomes, which encapsulate a target antigen and adjuvant. The vaccine formulation also relies on a hydrophobic oil carrier. The result is a depot effect that significantly enhances vaccine induced cell-mediated and humoral immunity.

The efficacy of a single dose of a DepoVax(TM) formulation was shown using a Human Papilloma Virus (HPV) associated cervical cancer model. In the therapeutic C3 tumor challenge model, DepoVax(TM) eliminated 100% of established cancerous tumors after a single dose. In contrast, tumors remained intact when treated with a placebo vaccine. The effect of the vaccine is linked to the activation of a potent and specific cellular immune response.

Read more ….

MedicalNewsToday.com

High-dose injections of vitamin C, also known as ascorbate or ascorbic acid, reduced tumor weight and growth rate by about 50 percent in mouse models of brain, ovarian, and pancreatic cancers, researchers from the National Institutes of Health (NIH) report in the August 5, 2008, issue of the Proceedings of the National Academy of Sciences. The researchers traced ascorbate’s anti-cancer effect to the formation of hydrogen peroxide in the extracellular fluid surrounding the tumors. Normal cells were unaffected.

Natural physiologic controls precisely regulate the amount of ascorbate absorbed by the body when it is taken orally. “When you eat foods containing more than 200 milligrams of vitamin C a day–for example, 2 oranges and a serving of broccoli–your body prevents blood levels of ascorbate from exceeding a narrow range,” says Mark Levine, M.D., the study’s lead author and chief of the Molecular and Clinical Nutrition Section of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the NIH. To bypass these normal controls, NIH scientists injected ascorbate into the veins or abdominal cavities of rodents with aggressive brain, ovarian, and pancreatic tumors. By doing so, they were able to deliver high doses of ascorbate, up to 4 grams per kilogram of body weight daily. “At these high injected doses, we hoped to see drug-like activity that might be useful in cancer treatment,” said Levine.

Read more ….

MedicalNewsToday.com

Researchers have developed what they believe is the first new mechanism in nearly 20 years for inhibiting a common target used to treat all HIV patients, which could eventually lead to a new class of AIDS drugs.

Researchers at the University of Michigan used computer models to develop the inhibiting compound, and then confirmed in the lab that the compound does indeed inhibit HIV protease, which is an established target for AIDS treatment. The protease is necessary to replicate the virus, says Heather Carlson, U-M professor of medicinal chemistry in the College of Pharmacy, and principal investigator of the study.

Carlson stresses this is a preliminary step, but still significant.

“It’s very easy to make an inhibitor, (but) it’s very hard to make a drug,” said Carlson, who also has an appointment in chemistry. “This compound is too weak to work in the human body. The key is to find more compounds that will work by the same mechanism.”

What’s so exciting is how differently that mechanism works from the current drugs used to keep the HIV from maturing and replicating, she says. Current drugs called protease inhibitors work by debilitating the HIV-1 protease. This does the same, but in a different way, Carlson says.

A protease is an enzyme that clips apart proteins, and in the case of HIV drugs, when the HIV-1 protease is inhibited it cannot process the proteins required to assemble an active virus. In existing treatments, a larger molecule binds to the center of the protease, freezing it closed.

The new mechanism targets a different area of the HIV-1 protease, called the flap recognition pocket, and actually holds the protease open. Scientists knew the flaps opened and closed, but didn’t know how to target that as a mechanism, Carlson says.

Carlson’s group discovered that this flap, when held open by a very small molecule—half the size of the ones used in current drug treatments—also inhibits the protease.

In addition to a new class of drugs, the compound is key because smaller molecules have better drug-like properties and are absorbed much more easily.

“This new class of smaller molecules could have better drug properties (and) could get around current side effects,” Carlson said. “HIV dosing regimes are really difficult. You have to take medicine several times in the day. Maybe you wouldn’t have to do that with these smaller molecules because they would be absorbed differently.”

Kelly Damm, a former student and now at Johnson & Johnson, initially had the idea to target the flaps in this new way, Carlson says.

“In a way, this works like a door jam. If you looked only at the door when it’s shut, you’d not know you could put a jam in it,” she said. “We saw a spot where we could block the closing event, but because everyone else was working with the closed form, they couldn’t see it.”

For more information on Carlson, click here.

College of Pharmacy: http://www.umich.edu/~pharmacy/

Source: Laura Bailey
University of Michigan

Eli Lilly and Company (NYSE: LLY) has announced the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer’s disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer’s disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer’s disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial - Interrupting Alzheimer’s Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a “randomized delayed start” design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

Read more ….

MedicalNewsToday.com

GlaxoSmithKline (NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Rotarix® [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants. Rotarix will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Since rotavirus disproportionately affects young children — severe rotavirus diarrhea and dehydration can occur as young as three months of age — Rotarix could help prevent many of the 55,000-70,000 hospitalizations of young children that result from rotavirus in the U.S. each year.

“Among children less than five years of age in the U.S. who are hospitalised due to rotavirus symptoms, approximately one in five is younger than six months of age,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “With only two doses, Rotarix allows infants to complete the vaccination series against rotavirus earlier than ever before, which may prevent many of the emergency department visits and hospitalizations that are a burden on families and the healthcare system.”

Read more ….

MedicalNewsToday.com

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today released clinical study results from the Phase I trial of EPC2407, which provided visible evidence of vascular disruptive activity. EPC2407 is EpiCept’s novel small molecule vascular disruption agent (VDA) and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas.

EpiCept has recently analyzed the imaging data from the first eight patients enrolled in the study who had measurable Computed Tomography (CT) perfusion scans. These patients received doses of EPC2407 ranging from 4mg/kg to 13mg/kg in three different cohorts. The results indicated that the disease had stabilized in seven of the eight patients studied. The CT perfusion scan measurements indicated that overall blood perfusion in the tumor decreased with EPC2407 treatment in the second and third cohorts, indicating an effective VDA dose had been reached. These data were measured five days after the last dose in a cycle, suggesting a sustained effect after dosing. In addition, the patients with stable disease over several treatment cycles had the greatest decreases in tumor perfusion as well as results indicative of decreased blood flow and decreased blood volume to the tumor, all suggesting a potential anti-tumor response.

The anti-cancer effect of EPC2407 was seen across a wide variety of advanced tumor types including patients with: pancreatic, non-small cell lung cancer, colon, prostate, gastrointestinal, metastatic melanoma, and parotid carcinoma. Patients were treated with up to five cycles of EPC2407.

Jack Talley, President and CEO of EpiCept Corporation, stated, “These data are strong evidence of VDA activity in patients enrolled in the trial and confirm previously published animal data that demonstrated the ability of EPC2407 to inhibit tumor growth in various cancers. We look forward to sharing these data more fully at upcoming cancer meetings later this year. We also are continuing our preparations for a Phase Ib trial for EPC2407 in combination with other chemotherapeutic agents, which we anticipate will commence later this year.”

EPC2407 has shown promising vascular targeting activity with potent anti-tumor activity in pre-clinical in vitro and in vivo studies. The molecule has been shown to induce tumor cell apoptosis and selectively inhibit growth of proliferating cell lines, including multi-drug resistant cell lines. Murine models of human tumor xenografts demonstrated EPC2407 inhibits growth of established tumors of a number of different cancer types.

In October 2007, EpiCept announced the successful completion of the Phase I clinical trial for EPC2407, with all of the trial’s objectives having been met. The Company has since decided to further enroll additional patients with an extended infusion time for the drug in order to determine whether higher doses can be tolerated.

EPC2407 is one of two compounds currently in clinical trials discovered through EpiCept’s Anti-cancer Screening Apoptosis Program (ASAP). The second compound, MPC-6827, is part of the EP90745 series of apoptosis inducers licensed by EpiCept to Myriad Genetics, Inc. as part of an exclusive, worldwide development and commercialization agreement. Myriad previously announced that MPC-6827, developed under the trademark Azixa™, has a second mode of action due to vascular disruption activity. The compound is currently being evaluated in three Phase II human clinical trials, one in patients with primary brain cancer and the others in brain metastases due to melanoma and in non-small cell lung cancer. EpiCept’s licensing agreement with Myriad for Azixa includes milestone payments, and sublicensing income as well as future royalties in the event Myriad’s development of Azixa continues to progress successfully.

About EpiCept’s ASAP Technology

Cancer cells often exhibit unchecked growth caused by the disabling or absence of the natural process of programmed cell death, which is called apoptosis. Apoptosis is normally triggered to destroy a cell from within when it outlives its purpose or it is seriously damaged. One of the most promising approaches in the fight against cancer is to selectively induce apoptosis in cancer cells, thereby checking, and perhaps reversing, the improper cell growth.

EpiCept’s proprietary apoptosis screening technology can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells through the use of chemical genetics and its proprietary live cell high-throughput caspase-3 screening technology. Chemical genetics is a research approach investigating the effect of small molecule drug candidates on the cellular activity of a protein, enabling researchers to determine the protein’s function. Using this approach with its proprietary caspase-3 screening technology, EpiCept researchers can focus their investigation on the cellular activity of small molecule drug candidates and their relationship to apoptosis.

This combination of chemical genetics and caspase-3 screening technology allows EpiCept’s researchers to discover and rapidly test the effect of small molecules on pathways and molecular targets crucial to apoptosis, and gain insights into their potential as new anticancer agents. ASAP technology is particularly versatile and can be adapted for almost any cell type that can be cultured, as well as measure caspase activation inside multiple cell types e.g., cancer cells, immune cells, or cell lines from different organ systems or genetically engineered cells. This allows researchers to find potential drug candidates that are selective for specific cancer types, which may help identify candidates that provide increased therapeutic benefit and reduced toxicity.

EpiCept has identified several families of compounds with potentially novel mechanisms that induce apoptosis in cancer cells. Several compounds from within these families have progressed to lead drug candidate status with proven pre-clinical efficacies in tumor models and identified molecular targets.

About EpiCept Corporation

EpiCept is focused on unmet needs in the treatment of pain and cancer. The Company’s broad portfolio of pharmaceutical product candidates includes several pain therapies in clinical development and a lead oncology compound for AML with demonstrated efficacy in a Phase III trial; a marketing authorization application for this compound is being re-examined in Europe following a negative opinion. In addition, EpiCept’s ASAP technology, a proprietary live cell high-throughput caspase-3 screening technology, can efficiently identify new cancer drug candidates and molecular targets that selectively induce apoptosis in cancer cells. Two oncology drug candidates currently in clinical development that were discovered using this technology have also been shown to act as vascular disruption agents in a variety of solid tumors.

Forward-Looking Statements

This news release and any oral statements made with respect to the information contained in this news release, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements which express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on EpiCept’s current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risks associated with our need to raise additional financing to continue to meet our capital needs and our ability to continue as a going concern, the risk that Ceplene® will not receive regulatory approval or marketing authorization in the EU or that any appeal of an adverse decision will not be successful, the risk that Ceplene®, if approved, will not achieve significant commercial success, the risk that Myriad’s development of Azixa™ will not be successful, the risk that Azixa™ will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myriad, the risk that the development of our other apoptosis product candidates will not be successful, the risk that our ASAP technology will not yield any successful product candidates, the risk that clinical trials for NP-1 or EPC2407 will not be successful, the risk that NP-1 or EPC2407 will not receive regulatory approval or achieve significant commercial success, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; risks associated with prior material weaknesses in our internal controls; and risks associated with our ability to protect our intellectual property.

These factors and other material risks are more fully discussed in EpiCept’s periodic reports, including its reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in EpiCept’s filings which are available at http://www.sec.gov or at http://www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.

EpiCept

Synvista Therapeutics, Inc. (Amex: SYI) announces data from a study of diabetic mice with the Haptoglobin 2-2 genotype that show impairment in the clearance of the Haptoglobin (Hp)-Hemoglobin (Hb) complex may result in a modification of high-density lipoprotein (HDL) structure and defective reverse cholesterol transport. These findings, which were presented at the 57th Annual Scientific Sessions of the American College of Cardiology in Chicago, suggest the value of Haptoglobin testing in people with diabetes in order to ensure more successful treatment in the prevention of cardiovascular events (such as heart attack and stroke).

“These data from a validated animal model support our belief that Haptoglobin testing may help physicians tailor optimal therapy for patients with diabetes who may be at risk for cardiovascular events. The transport of cholesterol out of atherosclerotic plaque may be an important mechanism of stroke and heart attack prevention. Characterizing the functional impairment of HDL may help us understand how to intervene in Hp2-2 diabetic patients,” said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer of Synvista Therapeutics, which is developing a diagnostic product to identify Haptoglobin types. “As with previous studies of diabetic patients exhibiting markedly elevated cardiovascular risk, we believe that these findings support the notion of testing for Haptoglobin and treating the appropriate diabetic patients (Hp2-2) with vitamin E.”

In the study, researchers assessed clearance of Hb by Hp in diabetic mice that were also tested for Hp type. The study showed that in these mice, the combination of diabetes and the Hp2-2 genotype was associated with a two-to-three-fold increase in the half-life of the Hp-Hb complex compared to other Hp types. Further, a greater than 10-fold increase was found in the association of Hp-2-Hb and HDL in these mice. The study also demonstrated that vitamin E supplementation prevented the impairment of reverse cholesterol transport in diabetic mice with the Hp2-2 genotype.

About Haptoglobin 2-2

The Hp protein is polymorphic in humans, occurring with two alleles, 1 and 2, existing at the Hp genetic locus. Three phenotypes linked to the three genotypes, Hp 1-1, Hp 1-2 and Hp 2-2, can be identified using an ELISA assay. In multiple independent prospective longitudinal studies of more than 20,000 individuals, it has been established that the Haptoglobin genotype is an independent risk factor for cardiovascular disease, with a specific relationship to patients with diabetes mellitus. After accounting for conventional cardiovascular risk factors and diabetes characteristics in these studies, research has demonstrated that there is a 2-5 fold increased risk of cardiovascular disease in people with both diabetes and the Hp 2-2 genotype (approximately 40 percent of all diabetes patients).

About Synvista Therapeutics

Synvista Therapeutics is a biopharmaceutical company developing drugs to treat and prevent cardiovascular disease and nephropathy in people with diabetes. The Company believes it has identified several product candidates that represent novel approaches to some of the largest pharmaceutical markets. The Company’s portfolio includes orally bioavailable, organoselenium mimics of glutathione peroxidase. These compounds metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. The Company is developing a clinical diagnostic test, based on cardiovascular risk assessment, using Haptoglobin characterization, to identify patients at high risk for cardiovascular complications of diabetes.

Synvista Therapeutics also is developing alagebrium, a proposed breaker of AGEs for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, allowing Synvista Therapeutics to assemble a sizeable human safety database. For more information, please visit the Company’s website at http://www.synvista.com.

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, the risks associated with the events described in this press release, future clinical development of Synvista Therapeutics’ product candidates, and other risks identified in Synvista Therapeutics’ filings with the Securities and Exchange Commission. Further information on risks faced by Synvista are detailed under the caption “Risk Factors” in Synvista Therapeutics’ Annual Report on Form 10-K for the year ended December 31, 2006. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Synvista Therapeutics undertakes no obligation to publicly release the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Synvista Therapeutics, Inc.
http://www.synvista.com

Artemisinins in Malaria Therapy, written by WRAIR researchers Dr. Qugui Li, Dr. Wilbur K. Milhous, and Dr. (COL) Peter J. Weina (Division of Experimental Therapeutics at the WRAIR, Silver Spring, MD) provides a fascinating overview of the historical use and recent developments in the treatment of one of the oldest and still one of the most prevalent scourges of mankind - malaria.

WRAIR, initially known as the Army Medical School, was founded in 1893 by then U.S. Army Surgeon General George Sternberg. In 1900 General Sternberg sent the newly appointed U.S. Army Yellow Fever Commission to Cuba headed by Major Walter Reed. Major Reed and his team became the first to confirm the theory that yellow fever was transmitted by a mosquito vector. Since this historic discovery, WRAIR’s many contributions to mankind in its 100 plus year history includes the discovery of the etiology and treatment of many of mankind’s leading killers.

More than half of the routine vaccines given to service members were co-developed by the military. Development of other licensed vaccines was supervised by investigators who began their careers at military research centers (e.g. yellow fever vaccine by former Army Surgeon General William Gorgas, mumps, measles, and varicella vaccines by Maurice Hilleman, and oral polio vaccine by Albert Sabin). Vaccines currently in advanced development stages include new adenovirus vaccines, and vaccines for malaria, dengue, and hepatitis E.

The history of using artemisinins for malarial like conditions dates back more than 2000 years to when it was a part of the herbal arsenal utilized in Traditional Chinese Medicine as a treatment for malarial like conditions. Artemisinins are derived from the sweet wormwood plant Artemisia annua which not only grows in China but also just down the road from WRAIR along the Potomac River. Revival of the use of artemisinins in the era of modern medicine began in China in the 1970’s with the first purified crystalline artemisinins produced in Shandon Province in 1972.

Although lead author Dr. Qigui Li received his MD and pharmacology degrees in China in the early 1980s, he did not become aware of artemisinins until the late 1980s, while a Post-doctoral Fellow at the Free University of Berlin, Germany. Dr. Li stated that “the Chinese had first published their findings in the Chinese Medical Journal in 1979, but when the WHO approached Chinese scientists for samples of the plant so they could conduct their own assays they were rebuffed. In retrospect, we can appreciate that this was just after the Nixon era, Mao Tse-tung was still in power, and the Chinese were very skeptical about sharing information for fear it would be utilized by the commercial pharmaceutical companies in the West for monetary gain.” Since joining the WRAIR team in 1991, Dr. Li has performed or supervised the majority of the pharmacodynamics and pharmacokinetics on all of the artemisinin derivatives.

In December of 2005, the World Health Organization stated, for the first time, artemisinins are the first line of therapy for most cases of malarial illnesses. Artemisinins are also being investigated as antiviral and anticancer agents.

—————————-
Dr. Dr. Qigui Li is currently the senior staff Pharmacologist and Section Chief of Pharmacokinetics/Pharmacodynamics in the Department of Pharmacology, Division of Experimental Therapeutics at the Walter Reed Army Institute of Research. He has received the WHO Research Fellowship Award, the NRC Research Associate Fellowship Award, and Best Investigator/PhD. Candidate from Schering Pharmaceuticals. Dr. Li received his Pharmacology/MD degree from Tongji Medical University, Wuhan, PR China in 1983 and his PhD in pharmacokinetics from the Free University of Berlin, West Berlin, FR Germany in 1989. Following the PhD in pharmacokinetics, Dr. Li completed a Postdoctoral Fellowship at the Free University of Berlin in 1991. He joined WRAIR in 1991.

Dr. Wilbur K. Milhous is currently a Professor of Global Health & Internal Medicine and serves as the Associate Dean for Research at the College of Public Health, University of South Florida (USF) in Tampa. He gained his 28 years of experience as a small molecule drug developer in numerous assignments at the WRAIR serving more recently as Chief Science Officer for Therapeutics and the Research Coordinator for the MIDRP. Under the mentorship of former WRAIR scientists Bob Desjardins and Craig Canfield, Dr. Milhous underwent his infectious disease chemotherapy training in a combined doctoral (University of North Carolina) and training with industry (GlaxoSmithKline) program prior to arriving at WRAIR in 1983. He was the first scientist to conduct in vitro testing of artemisinin extracts and has since been totally fascinated with the molecule resulting in numerous publications and patents. Dr. Milhous, along with former WRAIR colleague, Dennis Kyle, is currently teaching Critical Path Method as an academic discipline in the Global Health Infectious Diseases Research Program at USF Health.

Dr. (COL) Peter J. Weina is currently Chief, Pharmacology, , and Medical/Laboratory Director, Leishmaniasis Diagnostics Laboratory with the Division of Experimental Therapeutics at the Walter Reed Army Institute of Research, Silver Spring, MD. He is also Chair, Integrated Product Team for the Development of Intravenous Artesunate, Military Infectious Diseases Research Program and Medical Research and Material Command, Fort Detrick, MD. He received a PhD (Zoology & Pathology) from the University of Wisconsin-Madison in 1988 and completed his MD degree from the Uniformed Services University of Health Sciences in 1996. He completed a residency in Internal Medicine in 1999 and a Fellowship in Infectious Disease in 2002. Dr. Weina is currently a Fellow with the American College of Physicians and has been awarded one of America’s Top Physicians - Infectious Diseases (2004-2005).

Ardea Biosciences, Inc. (Nasdaq: RDEA) announced that data will be presented on its second generation non-nucleoside reverse transcriptase inhibitors (NNRTIs), at the 21st International Conference on Antiviral Research (ICAR). Additionally, data on two of the Company’s mitogen-activated ERK kinase (MEK) inhibitors, RDEA119 and RDEA436, will be presented at the American Association for Cancer Research (AACR) annual meeting.

The presentation details are as follows:

– 21st ICAR in Montreal, Quebec, Canada

Date/Time: Monday, April 14, 2008 at 4:00 p.m. Eastern Time
Title: A Novel NNRTI Class with Potent Anti-HIV Activity against
NNRTI-Resistant Viruses

Location: Poster Session 1 (Poster #80)

- AACR Annual Meeting in San Diego, California

Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA119, a Potent and Highly Specific MEK Inhibitor is
Efficacious in Mouse Tumor Xenograft Studies
Location: Poster Session 32 (Poster #4878), Exhibit Hall B-F

Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA436, a Novel MEK Inhibitor with Favorable
Pharmacokinetic Properties
Location: Poster Session 32 (Poster #4895), Exhibit Hall B-F

The possibility of having a kidney transplant without spending a lifetime on immunosuppressive drugs has come a step or two closer with the announcement this week of two studies using two new techniques to discourage rejection of the donor organ.

The studies are published in today’s issue of the New England Journal of Medicine (NEJM), 24th January.

In the first study which was carried out by researchers at Massachusetts General Hospital and Harvard Medical School in Boston, five patients with end stage kidney disease received combined bone marrow and kidney transplants from relatives that did not match. This was done in three stages. First their immune system was partly inactivated, then they were given a bone marrow graft from the donor, and then they received the donor’s kidney.

 Read more …….

MedicalNewsToday.com

By Alexis Madrigal

UroToday.com- Resiniferatoxin (RTX) and botulinum toxin type A (BTX-A) have drawn increasing attention in recent years as potential treatments for lower urinary tract symptoms (luts), including overactive bladder (OAB). RTX acts by desensitizing the transient receptor potential vanilloid type 1 (TRPV1) a non-specific Ca2+ channel previously known as vanilloid receptor. BTX-A is used in purified form as a medication for disorders involving involuntary muscle contractions including blepharospasm and strabismus. It acts by inhibiting the fusion of neurotransmitter-containing synaptic vesicles with the neuronal membrane an event essential for the release of neurotransmitters. It also reduces the release of glutamate and substance P from sensory neurons thus reducing the transmission of sensory input by these cells. Both drugs have been used in patients with bladder pain syndrome / interstitial cystitis. Cruz and Dinis from Porto, Portugal present an interesting review of the use of these compounds for the treatment of urinary disorders.

A role for intravesical RTX and BTX-A in the treatment of inflammatory bladder pain and frequency is strongly supported from data collected from animal models of chronic cystitis. Studies of RTX in humans for bladder pain syndrome are conflicting. A small randomized and placebo controlled trial of 18 patients showed good results at one month with no significant benefit at 3 months. A large pharmaceutical trial with 163 patients and several different doses of RTX compared to placebo showed no efficacy or even a potential signal of efficacy. For BTX-A, the results have also been contradictory in clinical trials. Not only is efficacy in question, but it carries risks of urinary retention that are not insignificant.

Read more ……

Medicalnewstoday.com

Studies published in the Jan. 10 edition of the New England Journal of Medicine (NEJM) are providing clues into the treatment and diagnosis of LAM, or lymphangioleiomyomatosis, a progressive and deadly lung disease that affects women in their childbearing years. There currently are no treatments for LAM and scientists estimate as many as 250,000 women may be going misdiagnosed or undiagnosed.

Researchers from Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine reported on a study testing the drug sirolimus in patients with LAM or tuberous sclerosis complex (TSC) with angiomyolipomas, benign kidney tumors common to both diseases. Approved to help transplant patients fight organ rejection, sirolimus treatment resulted in a 50 percent reduction in tumor growth; a significant improvement in lung function was observed in LAM patients. In addition, a letter published in the same issue of NEJM reports on preliminary data to support the use of a serum marker test to confirm a diagnosis of LAM. The disease has traditionally required a lung biopsy or CT scan for confirmation of diagnosis, contributing to diagnosis complications.

“These studies represent significant advances for LAM patients,” said Leslie Sullivan-Stacey, J.D., President and CEO of The LAM Foundation, a supporter of both studies. “The LAM Foundation has been the driving force behind major breakthroughs in LAM research over just the last decade, and we now have scientific evidence to support further study of treatments and diagnostic tools. The sirolimus study already is serving as the basis for other studies in TSC and LAM, including the first-ever LAM treatment trial, now enrolling patients.”

Read more ……

Medicalnewstoday.com

Emergent BioSolutions Inc. (NYSE: EBS) announced that the final analysis from a recently completed, randomized, placebo-controlled, blinded Phase II clinical study reaffirmed that its single-dose, drinkable typhoid vaccine candidate was highly immunogenic and well-tolerated with an acceptable safety profile in the population studied. For the study, a total of 151 Vietnamese children between 5 and 14 years of age were enrolled. A total of 101 children received the vaccine candidate and 50 children received placebo. This clinical study is the first trial involving a pediatric population and was performed in collaboration with the Wellcome Trust, Oxford University and the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.

Study Results

- 97% of the children dosed developed an immune response, which was defined as an increase in Salmonella typhi LPS-specific IgG antibody levels and/or Salmonella typhi LPS-specific IgA antibody levels in the blood, suggestive of systemic and mucosal protective immunity, respectively. This represented a statistically significant difference from the placebo group.

- 93% of the children developed responses as measured by increases in Salmonella typhi LPS-specific IgG antibody levels suggestive of systemic protective immunity and 94% developed an immune response as measured by increase in Salmonella typhi LPS-specific IgA antibody levels suggestive of mucosal protective immunity.

- There were no safety concerns following administration of a single dose of the drinkable typhoid vaccine candidate. The proportion of subjects reporting adverse events was similar for the vaccinated group (26%) and placebo group (22%); this difference was not statistically significant.

- There were no serious adverse events reported, no deaths and no subjects withdrew due to adverse events. There were small differences in specific adverse events with more gastrointestinal symptoms and headaches reported in the vaccinated group and more respiratory symptoms in the placebo group.

Read more ……

Medicalnewstoday.com

The first clinical studies of an experimental drug have revealed that obese people who take it for 12 weeks lose weight, even at very low doses. Short-term studies also suggest that the drug, called taranabant - the second drug designed to fight obesity by blocking cannabinoid receptors in the brain - causes people to consume fewer calories and burn more, researchers report in the January issue of Cell Metabolism, a publication of Cell Press. Cannabinoid receptors are responsible for the psychological effects of marijuana (Cannabis sativa), and natural “endocannabinoids” are important regulators of energy balance.

“The effects of marijuana on appetite have been known for millennia from its medicinal and recreational use,” said study author Steven Heymsfield of Merck Research Laboratories. “The ingredient responsible stimulates cannabinoid receptors. When you block the cannabinoid system with an antagonist like taranabant, you suppress appetite.” However, the drug, developed by Merck, also comes with an increased risk of adverse side effects at higher doses, the study shows, including mild to moderate gastrointestinal and psychiatric effects.

The first proof of concept that so-called cannabinoid 1 receptor (CB1R) inverse agonists might offer an obesity therapy came from studies of another drug, developed by Sanofi-Aventis, called rimonabant. That drug is now in use for weight loss in several European countries as an adjunct to diet and exercise but has not received FDA approval for use in the United States.

Read more ……

Medicalnewstoday.com

Researchers have developed a new method for presenting clinical trial survival data that includes data from all trial participants unlike the standard method, according to a commentary published online January 8 in the Journal of the National Cancer Institute.

In clinical studies, “time-to-event” data represents the time from the start of a study to an event, such as disease recurrence or death. But often many participants in a study do not experience an event before the study is over, so their survival time is not known. To overcome this data gap, the standard statistical method for presenting time-to-event results, known as the Kaplan-Meier survival curve, involves plotting the proportion of individuals surviving without an event over the period of the study. Using this method, researchers get an estimate of the median survival times. However, these plots also tend to make differences in survival between groups visually appear larger than they actually are.

To address this problem, Patrick Royston, D.Sc., of the Medical Research Council Clinical Trials Unit in London and colleagues developed a new method for plotting survival as a bar graph and tested it on data from a kidney cancer trial. In cases where a participant had not experienced an event, the researchers estimated that person’s survival by using their prognosis and length of time in the trial.

Read more ……

Medicalnewstoday.com

BIOVEN, a biotechnology company specializing in therapeutic vaccines for cancer, is targeting to raise US$16million to fund its clinical trials and fast track the commercialization of its three breakthrough therapeutic cancer vaccine products and a therapeutic hepatitis B vaccine.

The company secured ownership and rights to market the Cuban technology globally for US$32 million.

“We are looking for investors to come into the project,” said Chairman Mukhriz Mahathir. He said that the funds raised will be used for Phase II and III clinical trials for its EGF cancer vaccine and hepatitis B therapeutic vaccine in Asian and European sites. The monies will also be used for listing the company in 2 years time.

The company has embarked on Phase II/III clinical trials on the breakthrough cancer vaccine products, the most developed of which is the Epidermal Growth Factor (EGF) cancer vaccine on terminally ill, late stage non-small cell lung cancer (NSCLC) patients.

The head of the project, Dr Gisela Gonzalez Marinello, notes that the EGF is not a prophylactic vaccine but fights the regeneration of carcinogenic cells. It is injected once a month as a complement to traditional treatments such as chemotherapy and radiotherapy.

Read more ……

Medicalnewstoday.com

Surface Logix announced positive results in the Company’s Phase 2a clinical trial of SLx-2101 in hypertension. The randomized, double-blind, placebo-controlled crossover Phase 2a study in 60 patients with uncontrolled hypertension demonstrated that SLx-2101 caused clinically significant reductions in blood pressure and was well tolerated. The trial was designed to examine the safety, tolerability and effect on blood pressure in patients of repeat oral doses of SLx-2101 once daily for up to 14 days.

“These data confirm the promise of efficacy seen in earlier clinical trials, and we plan to initiate a Phase 2b study of SLx-2101 in hypertension in the third quarter of 2008,” said Jim Mahoney, President and CEO of Surface Logix. “We believe that with our demonstrated 24-hour coverage from once daily dosing and excellent tolerability profile, we will be able to uniquely position SLx-2101 in several segments of the hypertension market.”

SLx-2101 is an oral, potent, selective, fast-onset, long-acting PDE5 inhibitor. Other PDE5 inhibitors have traditionally been used to treat erectile dysfunction (ED). SLx-2101 was designed specifically to expand the therapeutic potential of PDE5 inhibition beyond ED into larger cardiovascular markets such as hypertension. SLx-2101 is uniquely positioned among the known PDE5 inhibitors to address cardiovascular disease because, compared to currently marketed PDE5 drugs, SLx-2101 preferentially distributes into cardiovascular tissue. With its large volume of distribution, SLx-2101 achieves sustained plasma levels and a long duration of action, without showing accumulation upon repeat dosing. This allows for daily or on demand dosing with a predictable response in a number of cardiovascular disorders that currently marketed PDE5 therapies cannot adequately address.

Read more ……

Medicalnewstoday.com

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cialis(R) (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses.

Currently available in parts of Europe, this low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity (e.g. twice weekly). For other men, Cialis taken as needed - the previously approved dosing regimen - may be most appropriate.

In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy.

“ED can be a chronic condition like diabetes or high blood pressure,” said Ridwan Shabsigh, M.D., Director of the Division of Urology at Maimonides Medical Center in New York. “As a urologist, I know couples like to have choices and will appreciate the availability of Cialis for once daily use.”

Cialis for use as needed transformed the U.S. ED market when it was approved in 2003 as the first and only PDE5 inhibitor clinically proven to provide sustained efficacy for up to 36 hours. Cialis for once daily use provides a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity. In consultation with their physician, patients now have the freedom to choose the dosing regimen that is appropriate for them.

Read more ……

Medicalnewstoday.com