BioPharmArena.com

A new study released by Cutting Edge Information, available at http://www.PharmaPublicationStrategy.com, examines medical publication efforts of pharmaceutical companies across a wide range of therapeutic areas. The study finds that, in response to legislation and pressure from the general public, pharmaceutical companies are now more regularly releasing both positive and negative results of their trials.

Rather than toss out adverse trial outcomes, pharmaceutical companies make them public both through traditional academic journals and through other mediums, such as http://www.clinicaltrials.gov, an online registry for clinical trials. Although regulatory scrutiny plays a role in this publication practice, concerns from the general public — payers, physicians, and ultimately the patients themselves — especially encourage openness.

“Companies find it worthwhile to release complete trial results, whether positive or negative,” says Amanda Zuniga, a senior research analyst at Cutting Edge Information. “Doing so shows the public that a company is acting in an honest, transparent manner.” In addition, most companies adhere to one or more sets of publication guidelines that encourage frankness and full disclosure of clinical performance.

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Medicalnewstoday.com

Immtech Pharmaceuticals, Inc. (Amex: IMM) announced that it has completed its first malaria prevention (or “malaria challenge”) trial of pafuramidine, Immtech’s oral drug candidate. The exploratory study was designed to determine whether the Company should focus on commercializing a blood-stage or a liver-stage malaria prevention drug. The information obtained from this study is needed by Immtech in order to design the appropriate subsequent trials for pafuramidine’s registration to target malaria prevention, and by the Independent Ethics Committees and the regulatory agencies in order to review and approve subsequent studies for this indication.

Malaria prevention potentially represents a significant market opportunity for Immtech. Datamonitor estimates the market potential for a product with pafuramidine’s expected profile to exceed US $1.0 billion globally.

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Memory Pharmaceuticals Corp. (Nasdaq: MEMY) announced positive top-line data from the randomized, placebo-controlled, multi-center Phase 2a proof-of-concept trial of MEM 3454, the Company’s lead nicotinic alpha-7 receptor partial agonist, in 80 patients with mild to moderate Alzheimer’s disease over an eight week treatment period. The trial was an exploratory efficacy study to learn about MEM 3454 as a potential treatment for Alzheimer’s disease. The primary endpoint of the trial was the change from baseline in the Quality of Episodic Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR) battery. QESM is a composite score derived from memory tests in the CDR battery that measure the ability to store, hold and retrieve information. There were three oral daily doses of MEM 3454 tested in the trial, 5 mg, 15 mg and 50 mg. The CDR battery was administered at baseline and on six days during the treatment period, at four time points (pre-dosing and 2, 4 and 8 hours post-dosing) each day. For the eight hour post-dose time points over the treatment period, subjects receiving 5 mg and 15 mg of MEM 3454 demonstrated a statistically significant effect on the QESM compared to placebo (p=0.023 and p=0.050, respectively).

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Medicalnewstoday.com

Early screening for lung cancer using non-invasive, low-dose CT scanning detects early stage cancers long before symptoms ever appear, according to results of a clinical study with 1,000 high-risk Canadian smokers.

The findings of the study led by radiologist Heidi Roberts at Princess Margaret Hospital (PMH), University Health Network are published in the October issue of the Canadian Association of Radiologists Journal.

“It is often too late to save lives when people become aware of symptoms. This is why early detection is so important,” says Dr. Roberts. “The sooner lung cancer is detected, the easier it is to treat, often less invasively, and certainly more cost effectively.”

Beginning in 2003, the study enrolled 1,000 Canadian smokers aged 55 and older, who had smoked at least a pack a day for 10 years. The study found that 26% of participants needed further testing, and 2.2% had cancer, which was treated in the meantime. A total of 3,600 Canadians have now been screened at PMH, the only Canadian site involved in the International Early Lung Cancer Action Program. The study oversees more than 35,000 participants worldwide.

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Medicalnewstoday.com

Healthcare providers have observed it for years — patients who appear to have a better quality of life while battling their cancer live longer. Now, a prospective, multi-institutional study examining the quality of life of patients with locally advanced non-small cell lung backs that observation. In fact, quality of life is so important, it out-weighs other classic predictors of survival.

“In the past, we’ve consider the stage of disease or tumor size along with other empirical data to predict how long a patient will survive, but now we know quality of life is a critical factor in determining survival,” said Nicos Nicolaou, M.D., an attending physician in the radiation oncology department at Fox Chase Cancer Center in Philadelphia and lead author of the abstract.

The study included patients with locally advanced non-small cell lung cancer enrolled in a treatment trial (Radiation Therapy Oncology Group 9801 assessing the addition of amifostine to induction chemotherapy followed by concurrent chemoradiation). In addition to quality of life surveys, factors used to predict overall survival, included stage of disease, gender, age, race, marital status, type of tumor, tumor location in the lung, blood oxygen level, and type of treatment.

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Medicalnewstoday.com

Treatment with a derivative of vitamin A called retinoic acid was associated with reduced lung cell growth in a group of former heavy smokers, according to a study published online October 30 in the Journal of the National Cancer Institute.

Former smokers remain at elevated risk for lung cancer. According to one hypothesis, lung cells that were damaged during years of smoking may continue to grow and evolve into cancer even after that person has quit smoking. Previous studies have suggested that retinoids, a class of drugs related to vitamin A, may be effective for preventing lung cancer in former smokers. Retinoids have also been shown to slow the growth of cancer cells in laboratory experiments.

Investigators at the University of Texas M.D. Anderson Cancer Center in Houston previously conducted a double-blind lung cancer prevention trial among 225 former heavy smokers. The subjects were randomly assigned to receive a 3-month treatment of 13-cis-retinoic acid and vitamin E, or 9-cis-retinoic acid, or a placebo. Walter Hittelman, Ph.D., and colleagues later examined biopsy samples of participants’ lung tissue taken before and after treatment, then measured the proliferation of the cells using a biomarker called Ki-67.

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Medicalnewstoday.com

Merck’s new integrase inhibitor, Isentress, approved last week by the Food and Drug Administration, used Roche Diagnostics’ COBAS(R) HIV-1 AMPLICOR viral load test during its clinical trials.

The new HIV drug, generically known as Raltegravir, is an HIV integrase inhibitor. Integrase inhibitors prevent replication of the virus by blocking insertion of HIV genetic material into human DNA. There are several other HIV integrase inhibitor drugs under development.

Isentress clinical trials researchers followed patients’ progress by testing their viral loads with Roche’s COBAS(R)HIV-1 AMPLICOR viral load test, which targets the gag region of the HIV virus genome, a different area from the integrase region where many new drugs in the HIV pipeline are being developed. Viral load testing, which quantifies the amount of HIV RNA in a patient’s blood, is critical for evaluating response to therapy and as an aid to optimize patient treatment.

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Medicalnewstoday.com