Monthly Archives: May 2003

Amgen Announces Positive Results Of Phase 3 Study For Treatment Of Severe Oral Mucositis

  • 5/28/2003
  • Thousand Oaks, Calif.
  • Amgen

Amgen (Nasdaq: AMGN), announced today that rHu-KGF decreased the duration and incidence of severe oral mucositis in a phase 3 study of patients undergoing bone marrow transplantation treatment for hematologic malignancies such as lymphoma, multiple myeloma, and leukemia. Natural keratinocyte growth factor stimulates the growth and development of epithelial cells, including the cells that line the gastrointestinal tract. Amgen is studying a recombinant human keratinocyte growth factor (rHu-KGF) to protect epithelial cells from injury caused by anti-tumor treatments such as radiation and chemotherapy. Mucositis is a painful and debilitating condition in which patients experience severe mouth ulcerations that can make swallowing difficult or impossible. Preliminary results from the Phase 3 randomized, double blind trial were positive on all end-points showing highly significant decrease in both the duration and incidence of severe mucositis. The trial also showed that KGF was well tolerated. Roger Perlmutter, Amgen’s executive vice president of research and development, said: There is no currently approved therapy to treat oral mucositis, a sometimes devastating complication of cancer chemotherapy. We are looking forward to discussing our phase 3 results that address this critical unmet medical need with regulatory agencies in the near future. Amgen will now investigate the efficacy and safety of KGF in other patient populations who suffer from high rates of mucositis associated with their anti-tumor treatments.

OCF NOTE: OCF is excited about Amgen bringing this product to market and investigating is efficacy in the treatment of oral mucositis, a considerable problem for patients undergoing radiation or chemotherapy for the treatment of oral cancer.

May, 2003|Archive|

Harbury Chef Beats The Odds With New Book

  • 5/27/2003
  • London, United Kingdom
  • CNN Europe

A renowned chef who was told by doctors to stop working and enjoy life after being diagnosed with secondary cancer is hoping his new recipe book will help others.

Guiseppe Iacaruso, known as Pino, went through major facial surgery in 1996 to beat a second attack of mouth cancer against all the odds and is still free of the disease seven years on.The esteemed Harbury chef has now combined his talents with food, words and watercolours in his first book, Flavours of Rosello, with a share of the profits going to the Get A-Head charity appeal. The 55-year-old of Penelope Close said: “It’s wonderful. I never expected it to look so lovely.”

Mr Iacaruso has cooked for several members of the royal family including the Queen, the late Princess Margaret and Prince and Princess Michael of Kent, has served in the kitchens of the Italian and Finnish Embassies and worked in some of the best hotels in the country during his career. The book is based on his childhood memories of the little Italian village of Rosello in the 1950s and 60s, and is introduced by Princess Michael of Kent. Packed with recipes and illustrated by Mr Iacaruso’s own watercolours and sketches by friend George Corbett, the enchanting book offers a month-by-month account of what life was like as he grew up in the Abruzzo region famed for its chefs. The idea for the memoirs came from his wife, Caroline, who he married in 1975. She suggested he write it as a record of his childhood memories to leave something for his son, Edilio. He began writing it 12 years ago as a hobby but progress juddered to a halt in 1995 when he was first diagnosed with cancer of the mouth. The tumour was removed and he got back to running his catering business Take Two Cooks with his wife, which recently branched out to include specialist wedding cake company As You Like It.

But months later, he felt a new growth develop. By an amazing coincidence, Mr and Mrs Iacaruso agreed to donate canapes for 250 people to a charity event organised by John Watkinson, a consultant surgeon of the Queen Elizabeth hospital cancer centre, for Get A-Head, who promised to see Mr Iacaruso that week. Mr Iacaruso lost his distinctive beard and had all his teeth removed for radiotherapy, but when that didn’t work, five consultants worked on him during a ten and a half hour marathon operation. It left him with severe scarring that robbed him of his looks but saved his life.
Since then, Mr and Mrs Iacaruso have raised more than £40,000 for Get A-Head through promise auctions, charity brunches, and auctioning off Mr Iacaruso’s watercolours – which have been exhibited at Walton Gallery and the Royal Academy.

May, 2003|Archive|

PET can assess efficacy of cancer treatment

  • 5/10/2003
  • New York
  • Karla Gale
  • Reuters Health News

British researchers report that positron emission tomography (PET) can measure levels of thymidine in tumors, an indicator of patient response to chemotherapy with agents that inhibit thymidylate synthase.

Their findings, published in the May 7th issue of the Journal of the National Cancer Institute, show that PET can be used broadly to “track cancer treatment efficacy without the need for repeated tissue biopsies,” coauthor Dr. Pat M. Price told Reuters Health. Not only will individual treatment assessment permit early recognition of treatment failure, such strategies should accelerate the rate at which clinical trials can be completed, she added.

Thymidylate synthase inhibitors such as 5-fluorouracil, 5-fluorodeoxyuridine and nolatrexed dihydrochloride (AG337; Agouron Pharmaceuticals, San Diego) target a key enzyme in the biosynthetic pathway of thymidine nucleotides used in the synthesis of DNA, Dr. Price and colleagues explain. Resistance to these agents involves a salvage pathway by which depleted thymidine levels are reversed by increasing exogenous thymidine uptake, which makes thymidine a valuable marker of tumor proliferation. Plasma levels of deoxyuridine, which increase following thymidylate synthase inhibition, do not reflect thymidylate synthase inhibition in specific tissues.

Dr. Price, of Christie Hospital NHS Trust in Manchester, UK, and her associates set out to evaluate PET scanning with radiolabeled thymidine as a means of measuring tumor thymidine incorporation, an indicator of thymidylate synthase inhibition. They conducted PET scanning in patients with advanced gastrointestinal cancer. Five patients enrolled in a phase I trial of AG337 were scanned 4 days before beginning treatment and then 1 hour after taking an oral dose. Radiolabeled thymidine was administered intravenously beginning 30 seconds after the start of PET scanning. Seven control patients were similarly evaluated.

The researchers observed an increase in tumor fractional retention of thymidine of 38% in the treated patients and a 3% increase in control patients, a significant difference (p = 0.028). Values for normal liver tissue did not differ significantly between groups. They also observed a strong correlation between tumor fractional retention of thymidine and plasma levels of deoxyuridine (p = 0.028).

Dr. Price told Reuters Health that PET technology has the potential for broad applicability apart from thymidylate synthase inhibitors and gastric cancers. Her group’s findings provide proof of principle that “this noninvasive strategy can also be used to evaluate cell apoptosis and drug transport, in addition to antiproliferative effects.”

“Now that the human genome is being mapped, we know far more about the specific molecules,” she added. “The challenge now is to know what happens when they are used to treat disease.”

J Natl Cancer Inst 2003;95:675-682.

May, 2003|Archive|