SciClone Pharmaceuticals Inc enrols first patient in Phase 2b trial of SCV-O7 for oral mucositis

Source: www.therapeuticsdaily.com Author: staff Specialist pharmaceutical company SciClone Pharmaceuticals Inc (NASDAQ:SCLN) revealed on Tuesday that the company has enrolled the first patient in its phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM), a painful, debilitating and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. The company said that the study will examine three doses of SCV-07, including two higher doses than those used in the recent phase 2a study, to assess the drug's impact on modifying the course of OM in patients with head and neck cancer. This multi-centre, randomised, double-blind, placebo-controlled study will enroll approximately 160 subjects who are receiving standard chemoradiation therapy for treatment of cancers of the head and neck. Subjects will be randomly assigned to one of the trial's four treatment arms: placebo and SCV-07 at doses of 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. According to the company, SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells.

Creating a killer pharmaceutical digital campaign begins with strategy

Source: blog.roskadigital.com Author: Kurt Mueller I’ve talked a lot recently about new technologies and even shown some examples of what I think are solid implementations in the pharmaceutical marketing and healthcare spaces. QR (quick response) codes, for example, are gaining traction. Nonprofit organizations like the American Cancer Society and the Oral Cancer Foundation have effectively used QR codes to promote disease awareness, and now other healthcare marketers are beginning to take note. We are even using them as part of branded product programs designed to engage young mothers and provide them with educational content served right to the device they use most…their smartphone. Now here’s the catch. All of these success cases began with a solid strategy, not with the technology. All too often marketers get caught up in the glitz and glam of the next hottest technology (or what they’ve heard from others) and then look for a product, brand or initiative in which to find it a home. This usually ends up with a campaign that’s a dud, get’s executive management upset, and usually reduces your budget the following year when you haven’t been able to deliver the goods in terms of ROI. I recently received an email as part of a product campaign I subscribe to (which shall remain nameless to spare them the shame), with a QR code at the bottom as a call to action. When I snapped the code it did nothing more than take me to an existing page on the product website [...]

Longitudinal changes over 2 years in parotid glands of patients treated with preoperative 30-Gy irradiation for oral cancer

Source: jjco.oxfordjournals.org Authors: Etsushi Tomitaka et al. Objective: To evaluate longitudinal changes in parotid volumes and saliva production over 2 years after 30 Gy irradiation. Methods: We retrospectively evaluated 15 assessable patients treated for advanced oral cancer. Eligibility criteria were a pathologic diagnosis of squamous cell carcinoma, preoperative radiation therapy with a total dose of 30 Gy delivered in 15 fractions, and the availability of longitudinal data of morphological assessments by computed tomography and functional assessments with the Saxon test spanning 2 years after radiation therapy. In the Saxon test, saliva production was measured by weighing a folded sterile gauze pad before and after chewing; the low-normal value is 2 g/2 min. Repeated-measures analysis of variance with Bonferroni adjustment for multiple comparisons was used to determine the longitudinal changes. Results: The normalized ipsilateral parotid volumes 2 weeks and 6-, 12- and 24 months after radiation therapy were found to be 72.5, 63.7, 66.9 and 78.1%, respectively; the normalized contralateral volumes were 69.8, 64.6, 72.2 and 82.0%, respectively. The bilateral parotid volumes were significantly decreased after radiation therapy (P

Three-drug combination shows long-lasting survival benefit in head and neck cancer patients

Source: www.medicalnewstoday.com Author: staff Adding a third drug (docetaxel) to a standard two-drug initial chemotherapy regimen significantly improves the long-term survival of patients with head and neck cancer, reducing the likelihood of dying by 26% over 6 years. The long-term results of the TAX 324 trial published Online First in The Lancet Oncology, confirm that this three-drug regimen should become the standard of care for patients who are suitable for induction therapy. Every year, cancers of the head and neck are diagnosed in more than 40 000 people in the USA. Standard treatment for these patients involves combining radiotherapy and chemotherapy with or without surgery, and the addition of induction chemotherapy has been shown to prolong survival. However, the best ways of combining these treatments remains unclear. In recent years, cisplatin plus fluorouracil (PF) has become a standard induction chemotherapy combination and has been shown to significantly prolong survival. The TAX 324 trial was designed to establish whether the addition of docetaxel to initial chemotherapy with cisplatin and fluorouracil (PF) might help patients with locally advanced head and neck cancer live longer. Between May 1999 and December 2003, 501 patients were recruited from 55 centres across the USA, Canada, Argentina, and Europe. In 2007, initial results (minimum follow-up 2 years) showed that induction chemotherapy with docetaxel, cisplatin, and fluorouracil (TPF) significantly improved survival compared with PF. To establish the durability of this survival benefit, Jochen Lorch from the Dana-Farber Cancer Institute, Boston, USA and colleagues evaluated the long-term follow-up of [...]

Victorian novel– Actress Colleen Zenk moves on & moves in

Source: NY Post By: Micki Siegel Right now, I’m starting everything over,” says actress Colleen Zenk. Zenk endured a series of terrible losses over the past year. In August, her 23-year marriage ended in divorce. A month later, “As the World Turns,” the CBS soap opera she’d worked on for 32 years (in the role of Barbara Ryan), went off the air. “I needed to start a new life with my kids,” Zenk, 57, says. So, she gathered up her 20-year-old-son, Morgan, and her 17-year-old daughter, Georgia (the last of her three children and three stepchildren who still live with her), four birds and two dogs and made a giant leap. They left behind the Redding, Conn., home Zenk had lived in throughout her marriage and moved about 20 minutes away, to Easton. And they did it fast; she barely gave herself time to think twice. “I saw this beautiful house and grabbed it quickly,” she says of the home she spotted last autumn. The 22-year-old reproduction of a Victorian house, which she rents, sits on 3 acres and measures about 4,000 square feet, and there’s an additional 1,000-square-foot suite over the garage. The house has a parlor, a family room, a dining room, a breakfast nook, four bedrooms, 4½ bathrooms and a home office. The over-the-garage suite boasts a bedroom, a dining area, an enormous bathroom and a walk-in closet bigger than the house’s living room. And though the house is relatively new, it’s full of classic details like [...]

The cost of living

Source: Author: Kathy Latour Cancer patients are living longer, but if radiation was part of their treatment, late effects may be a problem. Sam LaMonte, MD, knew he had cancer as soon as he touched the lump in his neck. It was 1991, and LaMonte, a head and neck surgeon in Pensacola, Florida, had just stepped down as the president of the Florida division of the American Cancer Society (ACS). “I told my partners I thought it was cancer, and they were in complete denial,” he recalls. “I wasn’t, because I had been feeling cancer in people’s necks my whole life.” LaMonte was right. A biopsy revealed cancer; the primary site was found at the base of his tongue. The diagnosis: stage 3 squamous cell head and neck cancer. The treatment: radiation twice a day for eight weeks. LaMonte, 50, resumed his career three months after he finished treatment. He picked up where he left off with the ACS, joining the national board and becoming the ACS poster boy for survivor issues even after he retired in 2002. Then in 2004, his doctor discovered from an X-ray that LaMonte’s left carotid artery was 100 percent blocked, and the right was 60 percent blocked. The damage, his doctor said, was the result of radiation that had saved his life 15 years earlier. LaMonte was a stroke waiting to happen. He had never had a symptom. “I was dumb as a door,” LaMonte says in retrospect. “So was my radiation oncologist about [...]

Finding survivor care

Source: www.curetoday.com Author: Kathy Latour In 2006, the Institute of Medicine and National Research Council released From Cancer Patient to Cancer Survivor: Lost in Transition. The goal of the study—the first of its kind—was to examine the range of medical and psychological issues faced by cancer survivors and to make recommendations to improve their health and quality of life. One such recommendation was to recognize that cancer survivors have unique medical needs and should have available, specialized follow-up care. Since then, clinicians and researchers have begun addressing the issues of who provides survivor care, how that care is delivered and what services should be available. Each year, an increasing number of cancer centers advertise the addition of survivorship programs. Some focus primarily on quality-of-life issues, while others offer a holistic approach of evaluation and recommendation for follow-up, says Linda Jacobs, PhD, RN, director of one of eight LIVESTRONG Survivorship Centers of Excellence, located at the University of Pennsylvania Abramson Cancer Center in Philadelphia. “Each emerging program is different,” Jacobs says. “They respond to regional needs as well as the population. Some only focus on one population of survivors, and some only provide services to their own patients.” This variation in services means survivors “have to have the knowledge to take care of themselves.” Jacobs says the first step is to document your treatment, either by calling the cancer center where you were treated or by completing a care plan using one of the available tools online, such as the LIVESTRONG [...]

Ban flavored tobacco products

Source: www.acscan.org Author: staff On 1/5/11, the Assembly introduced legislation banning the sale of flavored tobacco products. The American Cancer Society continues to be a strong advocate of this effort. Below is our memo of support: Memorandum In Support A. 288 An Act to amend the public health law, in relation to prohibiting the sale of flavored tobacco products. This measure prohibits the sale in New York of tobacco products, other than cigarettes, containing natural or artificial additives that impart to a tobacco product or its smoke flavors attractive to youth including, but not limited to, fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice flavoring. Menthol, mint and wintergreen flavors are excepted. In no event shall a tobacco product be construed as flavored based solely on the use of additives or flavorings in its manufacture, or their presence on an ingredient list. In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act granting the federal Food and Drug Administration authority to regulate tobacco products and banning the use of flavors other than menthol in cigarettes. However, other tobacco products, including "little cigars" (cigarettes wrapped in paper containing tobacco), cigars, snuff and other smokeless tobacco products were not included in the prohibition. This bill corrects that oversight. An important function of the flavorings affected by this legislation is to mask from tobacco product users, particularly new users, the harsh, toxic properties of tobacco smoke and spit tobacco. Tobacco industry internal documents uncovered during the course [...]

Radiation aids local control of head and neck mucosal melanoma

Source: www.oncolink.org ( from Reuters Health Information) Author: staff Radiotherapy after surgery for head and neck mucosal melanoma (HNMM) can help prevent local spread of the disease, according to a retrospective study from France. The study covered 160 patients treated over 28 years at 13 centers in the Groupe d'Etude des Tumeurs de la Tete et du Cou (GETTEC). It's the largest analysis to date of this rare cancer, according to lead author Dr. Adil Benlyazid of the Claudius Regaud Institute in Toulouse and colleagues. HNMM accounts for 3% of melanoma cases and 0.4% to 10% of melanomas of the head and neck, the researchers said in the December Archives of Otolaryngology and Head and Neck Surgery. Treatment typically involves surgery with or without postoperative radiotherapy, or radiotherapy alone if surgery is not feasible. Previous studies involving fewer subjects (i.e., 59 and 69 patients) found a benefit to adjuvant radiotherapy, but "there remains great skepticism, mostly among head and neck surgeons," according to Dr. Benlyazid and colleagues. Between 1980 and 2008, 82 HNMM patients had surgery at the GETTEC hospitals, and another 78 had surgery followed by radiotherapy. There was a nonsignificant trend toward more locally advanced tumor stage in patients who had adjuvant radiation. Overall and relapse-free survival didn't differ between the two groups. But the radiotherapy patients were significantly less likely to have locoregional recurrence as a first event, with a five-year cumulative rate of 55.6% with surgery alone vs 29.9% with surgery plus radiotherapy. After adjustment for [...]

Fraudulent autism vaccine study shows the flaws in medical journal system

Source: blogs.forbes.com Author: Robert Langreth The British Medical Journal’s conclusion that the original study that led to the autism vaccine scare was “an elaborate fraud” shows how flawed the current system for reviewing high-profile medical studies is. The study, by discredited British doctor Andrew Wakefield, was originally published in 1998 by the journal The Lancet, and was retracted last year. Now the BMJ has published an investigation by British journalist Brian Deer finding that the whole thing was a fraud. According to a BMJ editorial, “not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration…and that in no single case could the medical records be fully reconciled” with Lancet publication. The editorial concludes that there is “no doubt” that Wakefield was responsible. The study, with just 12 patients, was dubious from the beginning. Why did it take 12 astonishingly long years to find out the truth? Strict British libel laws may have had something to do with it. But the bigger problem is the limitations of the medical journal system. The Food and Drug Administration often examines much of the raw data when it analyzes whether to approve or restrict a drug. But medical journals rely more on the good faith of researchers and something called peer review, outside researchers who anonymously review papers. This is good at detecting conclusions that don’t match up with the data, flawed analysis, and and obviously faulty method. But it can leave them surprisingly vulnerable [...]

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