Call Us Today! 9837052040|[email protected]

Monthly Archives: March 2014

FDA allows Curis to resume testing cancer drug

(Reuters) – Curis Inc said the U.S. Food and Drug Administration allowed it to resume testing of its experimental cancer drug, lifting a November order halting enrolment in an early-stage trial.

The drugmaker’s shares rose as much as 13 percent in morning trading on the Nasdaq.

Enrolment for the study was halted after the death of a patient with advanced breast cancer, who experienced acute liver failure about a month after the drug, codenamed CUDC-427, was discontinued.

The trial began in the third quarter of 2013 in patients with advanced solid tumors or lymphomas.

The drug is designed to neutralize major inhibitors of apoptosis or programmed cell death – a process that ensures defective, damaged or superfluous cells are eliminated. Inhibition of apoptosis helps cancer cells persist and grow.

Many other cancer therapies, including chemotherapeutic agents, radiation and immunotherapy, also work by inducing apoptosis.

Curis acquired the license to develop and market the treatment from Genentech, a unit of the Roche Holding AG, for an upfront payment of $9.5 million in November 2012.

Curis said it intended to continue testing the drug as a monotherapy and evaluate its use in combination with chemotherapy drug, capecitabine, in patients of a type of advanced breast cancer.

Brean Capital analyst Daniel Brims said he expected the drug’s breast cancer study to begin in the second quarter of this year.

Other pharmaceutical companies, including Novartis AG and Ascenta Therapeutics Inc, are also developing therapies to regulate apoptosis.

Roth Capital Partners analyst Joseph Pantginis raised the […]

By |March 31st, 2014|blogs|0 Comments

Weight loss surgery helps reverse type 2 diabetes for some: study

By Bill Berkrot and Ransdell Pierson

WASHINGTON (Reuters) – Bariatric weight loss surgery on obese patients with type 2 diabetes helped many to get their blood sugar to healthy levels and to no longer require any diabetes medicines, including insulin, three years after the procedure, according to data presented at a major medical meeting on Monday.

The surgery also helped patients reduce the need for high blood pressure and cholesterol medicines and led to quality of life improvements compared with those who received medical weight-loss therapy, researchers found.

The study called Stampede, which involved 150 obese patients who had poorly controlled type 2 diabetes for at least eight years, was conducted by Cleveland Clinic researchers.

It compared two types of weight loss surgery against weight loss attained by diet and exercise along with nutrition counseling and, for some, additional diabetes medicines that can help promote weight loss, such as Victoza from Novo Nordisk. All patients were already taking at least three diabetes drugs and at least three heart medicines.

More than a third – 37.5 percent – of patients who underwent gastric bypass surgery and a quarter of those who had a sleeve gastrectomy procedure achieved blood sugar levels below the American Diabetes Association target and no longer needed diabetes medicines, researchers said. That compared with just 5 percent of patients in the medical therapy group who got their A1c blood sugar levels down to 6 percent or less. ADA recommendations call for A1c levels of 7 or less.

GSK pulls bid to extend use of kidney drug to ovarian cancer

LONDON (Reuters) – GlaxoSmithKline on Monday withdrew an application to use Votrient, a drug licensed for kidney cancer, to treat advanced ovarian cancer after analysis of data from a late-stage trial did not support the benefit-to-risk ratio.

The British company said it was disappointed by the findings of the further analysis, which came after it found the drug caused an improvement in progression-free survival in its Phase III study.

GSK, which had applied for approval in Europe, said it would also not continue to develop the drug for advanced ovarian cancer in other countries.

Votrient, which has the chemical name pazopanib, has been approved by many regulators as a treatment for advanced kidney cancer and some types of soft cell sarcomas.

(Reporting by Paul Sandle; Editing by David Goodman)

By |March 31st, 2014|blogs|0 Comments

Two Boston Hospitals Change Surgical Technique After Cancer Debate

Two Boston hospitals have made changes to a controversial surgical procedure after questions arose about its safety.

The technique, called morcellation, is characterized by a surgeon shredding tissue, usually fibroids or the uterus during a laparoscopic hysterectomy, that is then usually removed through a small incision in the abdomen.

Both Massachusetts General Hospital and Brigham and Women’s Hospital in Boston are changing guidelines about when to use morcellation just months after learning of at least two medical cases where women had undetected cancer spread into their abdomen following the procedure.

Read More About the Debate on Morcellation

The most high-profile case involved Dr. Amy Reed, an anesthesiologist at Beth-Israel Hospital in Boston, who had a laparoscopic hysterectomy with morcellation. Reed, 41, had undetected cancerous cells that were spread throughout her abdomen after the procedure. She is now being treated for Stage IV cancer.

Two medical articles questioning the safety of the technique were also published in the Journal of American Medical Association earlier this year.

After reviewing the cases, both Brigham and Women’s Hospital and Massachusetts General Hospital will allow morcellation only in cases where there is a very low chance of a cancer occurrence.

At Brigham and Women’s Hospital, no morcellation will be allowed without the tissue first being encased in a bag that will then be removed from the abdomen.

At Massachusetts General, only in very rare cases will morcellation be used without a containment system. Dr. Isaac Schiff, chief of Obstetrics and Gynecology at Massachusetts General Hospital, said there are some cases where a women […]

By |March 29th, 2014|blogs|0 Comments

FDA staff review raises questions about MannKind diabetes device

By Toni Clarke

WASHINGTON (Reuters) – A review of MannKind Corp’s experimental inhaled insulin device by U.S. Food and Drug Administration staff raised questions about its safety and effectiveness but was less damning than some investors had expected.

The company’s shares initially rose as much as 10.6 percent before falling back amid conflicting opinions from analysts on how the FDA will likely rule. The shares were down 3.3 percent at $5.03 in early afternoon trading.

The reviewers issued their report ahead of a meeting on Tuesday of outside advisers to the FDA, who will discuss clinical trial data and advise on whether the product, Afrezza, should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

Afrezza is a whistle-sized inhaler designed to deliver more effective, rapid-acting insulin than injectable products offered by Eli Lilly and Co and Denmark’s Novo Nordisk.

In early 2011, the FDA rejected Afrezza and asked for two more clinical trials, one for Type 1 diabetes and one for the more common Type II form of the disease. The FDA wanted MannKind to prove that a second-generation version of the device, known as the Dreamboat, was equivalent to a first-generation inhaler known as MedTone.

The FDA staff raised questions about dosing, missing data, bronchospasms, or constriction of the air passages of the lung, and Afrezza’s effect on lung function, but raised no major new safety concern.

“There do not appear to be any patterns suggesting a difference in […]

By |March 28th, 2014|blogs|0 Comments