Phase 3 Elagolix Trial Begins | News | Drug Discovery and Development Magazine

Elagolix (see structure) is an oral gonadotropin-releasing hormone (GnRH) antagonist. "Endometriosis can be a debilitating disease that affects millions of women around the world and the exploration of new treatments could offer other options for women with this disease," said Dr. Hugh Taylor, M.D., Chief of Division of Reproductive Endocrinology and Infertility, Yale School of Medicine.

The Phase 3 trial (M12-665) is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate-to-severe endometriosis-associated pain. It will be conducted at approximately 160 sites in the United States, Puerto Rico and Canada.

"The investigation of elagolix for endometriosis is an important step in the exploration of potential treatments for this underserved patient population," said Rita Jain, M.D., divisional vice president, Pain, Respiratory and Metabolic Development, Global Pharmaceutical R&D, Abbott.

The trial has begun screening for enrollment. A second Phase 3 study is planned with an NDA filing targeted in 2016.

Phase 3 Elagolix Trial Begins | News | Drug Discovery and Development Magazine

Nicotinamide riboside can protect against obesity

A natural ingredient found in milk can protect against obesity even as mice continue to enjoy diets that are high in fat. 

The researchers identified this ingredient, known as nicotinamide riboside (see structure), as they were searching for alternative ways to boost the well-known gene SIRT1, which comes with benefits for both metabolism and longevity. One way to do that is to target SIRT1 directly, as the red wine ingredient resveratrol appears to do, at least at some doses.

Auwerx's team lead by Johan Auwerx, suspected there might be a simpler way to go about it, by boosting levels of one of SIRT1's molecular sidekicks, the cofactor NAD+. 

This milk ingredient does just that in a rather appealing way. Not only is it a natural product, but it also gets trapped within cells, where it can do its magic.

Mice that take nicotinamide riboside in fairly high doses along with their high-fat meals burn more fat and are protected from obesity. They also become better runners thanks to muscles that have greater endurance.

http://www.youtube.com/embed/5YwzyqXzntY

Nicotinamide riboside can protect against obesity

BioLineRx receives two U.S. patent allowances for BL-1021 to treat neuropathic pain

BioLineRx, a biopharmaceutical development company, announced today that two Notices of Allowance have been issued by the United States Patent and Trademark Office (USPTO) for BL-1021 (see structure), an orally available small molecule for treating neuropathic pain. The first has been issued for a patent application claiming BL-1021's composition, that when issued, will be valid until at least September 2022. Additional patents claiming BL-1021's composition are granted or pending in Europe, Japan, Canada, Korea, Mexico, Israel, India, China and Australia. The other Notice of Allowance is for a patent application claiming the use of BL-1021 for the treatment of pain, that when issued, will be valid until at least January 2028.

BioLineRx receives two U.S. patent allowances for BL-1021 to treat neuropathic pain: BioLineRx, a biopharmaceutical development company, announced today that two Notices of Allowance have been issued by the United States Patent and Trademark Office (USPTO) for BL-1021, an orally available small molecule for treating neuropathic pain.

Novel way to treat drug-resistant brain tumor cells

In continuation of my update on Lapatinib

Research by Dr. Paul Clark, a scientist in Kuo's lab and the study's lead author, shows why. When cetuximab treatment switches off EGFR activity and should inhibit cancer-cell growth, cancer stem cells compensate by turning on two other EGFR family receptors (ERBB2 and ERBB3) and continue to grow. One of these receptors, ERBB2, is implicated in certain types of chemotherapy-resistant breast cancer. Fortunately, another novel drug already approved by the FDA, lapatinib (see the structure), inhibits ERBB2 activity and signaling by multiple EGFR members.

This study shows that cancer stem-cell growth was markedly inhibited by lapatinib treatment, which results in combined knockout of multiple EGFR family members.

"This is good news, because these drugs target an important mechanism for the (GBM) cancer cells to grow so quickly and evade current therapies, and these molecularly targeted drugs are also well-tolerated by patients and have minimal side effects," Dr. Clark said.

Ref : http://www.med.wisc.edu/news-events/wisconsin-research-team-reveals-novel-way-to-treat-drug-resistant-brain-tumor-cells/37811

Novel way to treat drug-resistant brain tumor cells: New research explains why the incurable brain cancer, glioblastoma multiforme (GBM), is highly resistant to current chemotherapies.

Increased fiber intake associated with lower risk of dying over twelve year period - Life Extension Update

Fiber could promote health via several mechanisms, including helping to control weight, improving glycemic control, and aiding in the maintenance of a favorable intestinal environment. Fiber may help protect against circulatory diseases by lowering low density lipoprotein (LDL) cholesterol, which, when elevated, is a major risk factor for cardiovascular disease. Fiber intake has also been associated with a reduction in inflammatory markers including C-reactive protein, interleukin-6 and tumor necrosis factor-alpha. The authors note that greater total fiber intake could be a marker of an overall dietary pattern that benefits health.

"We observed inverse associations between total dietary fiber intake and mortality, and specifically mortality from circulatory, digestive, and non-cardiovascular disease, noncancer inflammatory diseases," the authors conclude. "These results show that high fiber intake, mainly from cereals and vegetables, may reduce the risk of death from these diseases." 

Increased fiber intake associated with lower risk of dying over twelve year period - Life Extension Update

Drug Combo Tackling Solid Tumors

Cancer Research UK's Drug Development Office has opened the first trial of a new drug combination in patients with advanced solid tumors and in a subset of patients who have non-small cell lung cancer. This trial will combine two compounds that aim to starve the tumors while simultaneously blocking cancer cell growth.

The study will take place across three UK hospitals. The Churchill Hospital, Oxford is the lead center. The trial of up to 48 patients will run in two stages. In the first stage patients with any solid tumor will each receive a drug called vandetanib (below left) and an investigational drug called selumetinib (right structure below)AZD6244, ARRY142886). In the second stage patients with non-small cell lung cancer (NSCLC) will receive the combination.

This is the first time the compounds have been trialled together. It is hoped that combining these treatments will increase the number of cancer ‘weakspots’ targeted at the same time.

Chief investigator, Dr. Denis Talbot, consultant medical oncologist at Oxford University Hospitals NHS Trust and Cancer Research UK clinician at The University of Oxford, said: “Therapies for lung cancer often become ineffective because the disease becomes resistant to treatment, so we’re delighted to launch this trial to test a new approach that we hope will help people with this common disease.

“There is progress being made in the treatment of lung cancer but survival rates still remain low. This is because the majority of patients – up to two thirds – are diagnosed once the cancer has already spread to other organs when it’s more difficult to treat successfully.

 “We hope that this new approach may eventually contribute to increased survival for lung cancer patients.”

Ref : http://cancerhelp.cancerresearchuk.org/trials/a-trial-of-vandetanib-and-selumetinib-for-solid-tumours-including-nsclc-vansel-1

Takeda announces updated results from orteronel phase 2 study on nmCRPC

Takeda announces updated results from orteronel phase 2 study on nmCRPC: Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced updated results from a phase 2 study of orteronel, a selective oral 17,20 lyase inhibitor, dosed without prednisone in patients with non-metastatic castration resistant prostate cancer (nmCRPC) and rising prostate-specific antigen.

Ref : http://investor.millennium.com/phoenix.zhtml?c=80159&p=irol-newsArticle&ID=1702187&highlight=

Antisense Pharma presents data from trabedersen Phase I/II cancer study at ASCO 2012

In continuation of my update on antisense drugs

Trabedersen, is an antisense compound that specifically inhibits expression of transforming growth factor beta 2 (TGF-β2) – a protein which is overexpressed in advanced tumors and which triggers key cancer pathomechanisms, i.e. suppression of antitumor immune response and metastasis. 

Antisense Pharma presents data from trabedersen Phase I/II cancer study at ASCO 2012: The biopharmaceutical company Antisense Pharma today presents trabedersen complete data from its clinical Phase I/II study in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer at the international cancer congress ASCO 2012 in Chicago, USA.

Ancient berry could protect against diabetic retinopathy

In continuation of my update on wolfberry

Ancient berry could protect against diabetic retinopathy: The ancient Tibetan goji berry could help fight blindness caused by long-term diabetes according to studies conducted by University of Sydney researchers.

Dapivirine Phase III trial now underway in Africa to treat HIV in women

Dapivirine Phase III trial now underway in Africa to treat HIV in women