New compound appears to play role in development of opioid tolerance

While opioids are a widely used treatment for pain, patients who take them on a regular basis can become tolerant, requiring a higher dose for continued pain relief. In a study published in Anesthesiology, the official medical journal of the American Society of Anesthesiologists® (ASA®), researchers identified a compound that appears to play a role in the development of opioid tolerance. It may be possible to lessen the development of opioid tolerance if that compound is neutralized or blocked in patients taking opioids chronically for severe pain.

"Opioid tolerance is a growing problem among chronic pain patients and cancer patients in particular," said Chih-Peng Lin, M.D., assistant professor, Department of Anesthesiology, National Taiwan University College of Medicine. "We found that CXCL1, a protein produced by spinal cord tissue, contributes to opioid tolerance. By neutralizing CXCL1 in patients, we might help solve the problem of opioid tolerance."

New compound appears to play role in development of opioid tolerance

Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis

Olopatadine hydrochloride is an antihistamine (as well as anticholinergic and mast cell stabilizer), sold as a prescription eye drop (0.2% solution, Pataday (or Patanol S in some countries), manufactured by Alcon). It is used to treat itching associated with allergic conjunctivitis (eye  allergies). Olopatadine hydrochloride 0.1% is sold as Patanol (or Opatanol in some countries). A decongestant nasal spray formulation is sold as Patanase, which was approved by the FDA on April 15, 2008.  It is also available as an oral tablet in Japan under the tradename Allelock, manufactured by Kyowa Hakko Kogyo.

Alcon, the global leader in eye care and a division of Novartis, has received approval from the U.S. Food and Drug Administration (FDA) of Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, for the treatment of ocular itching associated with allergic conjunctivitis. Pazeo solution is dosed one drop daily, and was approved with efficacy data at 24 hours, post dose.

Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis

Eliglustat drug improves liver, spleen size and hemoglobin level in adults with Gaucher disease type 1

In continuation of my update on eliglustat  

Among previously untreated adults with Gaucher disease type 1, a genetic disease in which there is improper metabolism due to a defect in an enzyme, treatment with the drug eliglustat resulted in significant improvements in liver and spleen size hemoglobin level, and platelet count, according to a study in the February 17 issue of JAMA.

Gaucher disease type 1 is characterized by enlargement of the spleen and liver, anemia, low blood platelets, chronic bone pain, and the failure to grow properly. Untreated Gaucher disease type 1 is a chronic and progressive disorder associated with disability, reduced life expectancy, and, in some patients, life-threatening complications. The current standard of care is enzyme replacement therapy, which requires lifelong intravenous infusions every other week. A safe, effective oral therapy is needed, according to background information in the article. 

Pramod K. Mistry, M.D., Ph.D., F.R.C.P., of the Yale University School of Medicine, New Haven, Conn., and colleagues randomly assigned 40 untreated adults with Gaucher disease type 1 to receive eliglustat (twice daily; n = 20) or placebo (n = 20) for 9 months. Eliglustat is a novel oral medication, which showed favorable results for patients with this disease in a phase 2 trial. This phase 3 trial was conducted at 18 sites in 12 countries.

The researchers found that administration of eliglustat resulted in a reduction in spleen volume of approximately 30 percent compared with placebo, as well as improvements in hemoglobin level, decreased liver volume (-6.6 percent), and increased platelet count (41 percent). No serious adverse events occurred. No patient discontinued treatment over the course of the 9-month study because of a treatment-emergent adverse event.

Eliglustat drug improves liver, spleen size and hemoglobin level in adults with Gaucher disease type 1

New molecule shows promise in controlling HIV without using daily antiretroviral drugs

Scientists have created a new molecule that shows promise for controlling HIV without daily antiretroviral drugs. The molecule foils a wider range of HIV strains in the laboratory than any known broadly neutralizing HIV antibody and is more powerful than some of the most potent of these antibodies. In addition, the molecule safely protected monkeys from infection with an HIV-like virus during a 40-week study period. Together, the data suggest that the molecule could, with further research, be used to subdue HIV in humans. The authors note that the molecule potentially could be used as both a preventative drug and as a treatment. The new findings appear in the February 18 issue of the journal Nature.

"This innovative research holds promise for moving us toward two important goals: achieving long-term protection from HIV infection, and putting HIV into sustained remission in chronically infected people," said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

Ref : http://www.nature.com/nature/journal/vaop/ncurrent/full/nature14264.html

New molecule shows promise in controlling HIV without using daily antiretroviral drugs

Eli Lilly accepts committee recommendation to extend evacetrapib Phase 3 trial

We know that, Evacetrapib  is a  drug under  development by  Eli Lilly  and  company (investigational   name   LY2484595)      that inhibits cholesterylester transfer protein (CETP), which  transfers and thereby increases high-density lipoprotein and     lowers   low-density lipoprotein. It is thought that modifying lipoprotein levels modifies the    risk     of     cardiovascular   disease.   The  first  CETP inhibitor, torcetrapib, was unsuccessful because it increased levels of the hormone aldosterone and increased blood pressure, which led to excess cardiac events when it was studied.  Evacetrapib does not have the same effect. When studied in a small clinical trial in people with elevated LDL and low HDL, significant improvements were noted in their lipid profile.

A recent report states that,  Eli Lilly and Company (NYSE: LLY) has accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, to extend the Phase 3 trial of the investigational medicine evacetrapib by approximately six months. The decision is not based on any data from ACCELERATE, as both the academic committee and the company remain blinded to efficacy results............

Eli Lilly accepts committee recommendation to extend evacetrapib Phase 3 trial

Palbociclib extends progression-free survival in advanced breast cancer patients

In continuation of my update on Palbociclib

Palbociclib, an investigational oral medication that works by blocking molecules responsible for cancer cell growth, is well tolerated and extends progression-free survival (PFS) in newly diagnosed, advanced breast cancer patients, including those whose disease has stopped responding to traditional endocrine treatments. Results of the phase II study, led by researchers in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania , were published this month in Clinical Cancer Research. Earlier phase I results by researchers at Penn Medicine contributed to the development of palbociclib, which was recently approved by the U.S. Food and Drug Administration (FDA) for metastatic breast cancer patients just beginning to undergo endocrine therapy.

"The FDA approval has expanded treatments options for many metastatic breast cancer patients, but these new results are showing how effective the drug can also be for breast cancer patients who have already tried endocrine therapies and may be running out of options," said lead investigator Angela DeMichele, MD, MSCE , associate professor in the division of Hematology/Oncology and Epidemiology and co-leader of the Breast Cancer Research Program at the Abramson Cancer Center. "Combined with the promising results from other trials looking at the effectiveness of this drug, our results indicate that palbociclib can extend the duration of disease control and produce tumor shrinkage in patients with estrogen-receptor positive (ER+) breast cancer, without the debilitating side effects of chemotherapy."

The newly-published phase II trial primarily sought to evaluate disease response and control, while monitoring for the presence of side effects such as neutropenia, an abnormally low white blood cell count. Patients enrolled in the trial had previously undergone several prior chemotherapy and hormonal regimens for metastatic disease. Palboclib was administered once daily for 21 days each month.

Overall, researchers noted a median PFS, the time before a tumor worsens or the patient dies, of 3.7 months for patients taking the drug. However, patients with hormone receptor-positive (HR+) breast cancer -where the breast cancer cells depend on the hormones estrogen and progesterone to grow - had significantly longer PFS (5.1 months) compared to that of the HR-negative group (84 percent and 11 percent of the enrolled population, respectively). And those who had previously progressed through at least two rounds of hormonal therapy saw significantly greater benefits, suggesting substantial activity in the setting of acquired endocrine resistance.

Palbociclib extends progression-free survival in advanced breast cancer patients

Mayo Clinic researchers identify molecule that lays groundwork for development of pancreatic cancer

A research team led by investigators from Mayo Clinic's campus in Jacksonville, Florida, and the University of Oslo, Norway, have identified a molecule that pushes normal pancreatic cells to transform their shape, laying the groundwork for development of pancreatic cancer -- one of the most difficult tumors to treat.

Their findings, reported in Nature Communications, suggest that inhibiting the gene, protein kinase D1 (PKD1), and its protein could halt progression and spread of this form of pancreatic cancer, and possibly even reverse the transformation.

"As soon as pancreatic cancer develops, it begins to spread, and PKD1 is key to both processes. Given this finding, we are busy developing a PKD1 inhibitor that we can test further," says the study's co-lead investigator, Peter Storz, Ph.D., a cancer researcher at Mayo Clinic.

http://www.nature.com/ncomms/2015/150220/ncomms7200/full/ncomms7200.html

Mayo Clinic researchers identify molecule that lays groundwork for development of pancreatic cancer

Lenvatinib trial offers hope for thyroid cancer patients

A new targeted therapy called lenvatinib has been shown to improve progression-free survival among patients with advanced thyroid cancer that is not responsive to iodine-131.

In a clinical trial of almost 400 patients from 21 different countries, patients who took lenvatinib survived for a median of 18.3 months without displaying any signs of disease progression, while those who were given placebo only had a median progression-free survival of 3.6 months.

"The median progression-free survival in the placebo group in this study was shorter than the 8 months expected, indicating that these patients had aggressive thyroid cancer," write the authors of the study, which was published in the New England Journal of Medicine.

Given the results of this trial, lenvatinib may become the standard treatment for patients resistant to idoine-131, says lead author Martin Schlumberger from the Department of Nuclear Medicine and Endocrine Oncology at Gustave Roussy in France.

Lenvatinib trial offers hope for thyroid cancer patients

New antibody shows promise in increasing survival for patients suffering from influenza, pneumonia

Scientists from NTU Singapore, the world's No. 1 young university, have developed an antibody which boosts the survival chances for patients suffering from influenza and pneumonia.

Proven effective in lab tests, the antibody is now being made suitable for use in humans. The scientists are also using the new antibody to develop a diagnostic kit which can help doctors accurately track the recovery progress of flu and pneumonia patients.

The patent-pending antibody has generated much interest globally. Two biotech multi-national corporations, Abcam based in the United Kingdom and Adipogen International based in the United States, have won the rights to license the antibody. The two multinational companies will produce the antibody for sale to global organisations doing research in vaccine and drug development.

The breakthrough finding was published in the latest issue of the prestigious international peer-reviewed journal Cell Reports.

Ref : http://www.cell.com/cell-reports/abstract/S2211-1247(15)00024-8

New antibody shows promise in increasing survival for patients suffering from influenza, pneumonia

Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the company's receptor tyrosine kinase inhibitor LENVIMA™ (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). LENVIMA was approved following a priority review by the FDA, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition. LENVIMA demonstrated a statistically significant progression-free survival (PFS) prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine (RAI) therapy.

"In the pivotal Phase 3 SELECT clinical trial, recently published in the New England Journal of Medicine, treatment with LENVIMA resulted in a highly statistically significant improvement in progression-free survival and a high overall response rate in patients with locally recurrent or metastatic, progressive, RAI-refractory DTC," said Lori J. Wirth, M.D., study investigator and medical director of the Center for Head and Neck Cancers at the Massachusetts General Hospital. "The thyroid cancer community welcomes an agent that offers a significant, effective option for the treatment of differentiated thyroid cancer in patients who have progressed after becoming refractory to RAI therapy."

Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC