Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDAs) for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen®, marketed by Eisai Pharmaceuticals. Lannett previously received and currently markets Pilocarpine HCI tablets, in the 5 mg strength. According to Wolters Kluwer, sales in 2008 of both generic and brand Pilocarpine HCI 7.5 mg tablets were $2.5 million at Average Wholesale Price.

Pilocarpine HCI tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.

“This approval adds an important dosage strength to our Pilocarpine product offering,” said Arthur Bedrosian, president and chief executive officer of Lannett. “We are now able to offer our customers one stop shopping for both strengths.”

Source
Lannett Company

Researchers at the Hebrew University of Jerusalem have discovered a method to potentially eliminate the tumor-risk factor in utilizing human embryonic stem cells. Their work paves the way for further progress in the promising field of stem cell therapy.

Human embryonic stem cells are theoretically capable of differentiation to all cells of the mature human body (and are hence defined as “pluripotent”). This ability, along with the ability to remain undifferentiated indefinitely in culture, make regenerative medicine using human embryonic stem cells a potentially unprecedented tool for the treatment of various diseases, including diabetes, Parkinson’s disease and heart failure.

A major drawback to the use of stem cells, however, remains the demonstrated tendency of such cells to grow into a specific kind of tumor, called teratoma, when they are implanted in laboratory experiments into mice. It is assumed that this tumorigenic feature will be manifested upon transplantation to human patients as well. The development of tumors from embryonic stem cells is especially puzzling given that these cells start out as completely normal cells.

A team of researchers at the Stem Cell Unit in the Department of Genetics at the Silberman Institute of Life Sciences at the Hebrew University has been working on various approaches to deal with this problem.

In their latest project, the researchers analyzed the genetic basis of tumor formation from human embryonic stem cells and identified a key gene that is involved in this unique tumorigenicity. This gene, called survivin, is expressed in most cancers and in early stage embryos, but it is almost completely absent from mature normal tissues.

The survivin gene is especially highly expressed in undifferentiated human embryonic stem cells and in their derived tumors. By neutralizing the activity of survivin in the undifferentiated cells as well as in the tumors, the researchers were able to initiate programmed cell death (apoptosis) in those cells.

This inhibition of this gene just before or after transplantation of the cells could minimize the chances of tumor formation, but the researchers caution that a combination of strategies may be needed to address the major safety concerns regarding tumor formation by human embryonic stem cells.

A report on this latest project of the Hebrew University stem cell researchers appeared in the online edition of Nature Biotechnology. The researchers are headed by Nissim Benvenisty, who is the Herbert Cohn Professor of Cancer Research, and Ph.D. student Barak Blum. Others working on the project are Ph.D. student Ori Bar-Nur and laboratory technician Tamar Golan-Lev.

Source:
Jerry Barach

The Hebrew University of Jerusalem

UroToday.com - In the Prostate Cancer Prevention Trial (PCPT), men randomized to 7 years of finasteride 5mg daily demonstrated a 24.8% reduction in the incidence of prostate cancer (CaP) relative to men on placebo. However, there was an increased prevalence of Gleason score 7-10 in the finasteride group compared to placebo (6.4% vs. 5.1%). In the online edition of Urology, Dr. Kaplan and associate investigators report on an analysis of the PCPT data, adjusted for prostate volume.

Men on finasteride had a 24% reduction in the prostate volume (PV) but the same number of biopsy cores taken. This computed to a 27% increase in the mean prostate biopsy sampling density for finasteride patients compared to placebo. Adjusting for biopsy sampling density, Cohen had reported that the CaP risk reduction was actually 45% relative to placebo and there was a significant reduction in the risk of low-grade cancer with no significant effect on the risk of high-grade cancer. However, these reports did not allow for determination of the individual Gleason scores for which finasteride had a beneficial effect on CAP risk after adjustment for the biopsy sampling density. This study used a post hoc generalization of the pre-specified biopsy sampling density-adjusted analysis to examine the effect of finasteride on CaP risk relative to placebo at each individual Gleason score in the PCPT.

Among the 8,827 men who had biopsy sampling density measurements, 1,739 had CaP diagnosed - 1,031 in the placebo group and 708 in the finasteride group. The most frequently detected CAP was Gleason score 5, 6, and 7 cancer. The mean PV was 33.5cc in the placebo group and 25.2cc in the finasteride group. Finasteride significantly reduced the risk of CaP relative to placebo across Gleason score groups 4 to 7 with a 64% reduction on Gleason score 4, 58% reduction for Gleason score 5, 52% reduction for Gleason score 6 and 22% reduction in Gleason score 7. Finasteride had no effect on the individual Gleason score 8 through 10 prostate cancers. Finasteride led to a significant reduction in the probability of detecting CAP with a clear separation at year 2 that continued to increase through year 7.

Kaplan SA, Roehrborn CG, Meehan AG, Liu KS, Carides AD, Binkowitz BS, Heyden NL, Vaughan ED Jr
Urology. 2009 Mar 26. Epub ahead of print.
doi:10.1016/j.urology.2008.09.079

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to:
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Copyright © 2009 - UroToday

The latest science-based guidelines on nutrition and exercise as they relate to prostate health and cancer prevention are now available in a new publication from The Prostate Cancer Foundation (PCF). The guide,Nutrition, Exercise and Prostate Cancer, is available in electronic form on the foundation’s website, http://www.pcf.org. Individuals can also order a printed copy of the booklet online.

The comprehensive guide covers a wide variety of topics including an easy-to-follow scientific discussion of specific diet and nutrition recommendations, the effects of obesity on cancer and other diseases, and a description of the benefits of regular exercise in maintaining a healthy lifestyle. Tips are also provided for implementing a plan for success. The 28-page guide is authored by four of America’s leading scientists and physicians working in the field of prostate cancer and nutrition research: David Heber, M.D., Ph.D., of the UCLA Center for Human Nutrition; Stephen J. Freedland, M.D., Duke Prostate Center at Duke University Medical Center; Lee. W, Jones, Ph.D., Duke University Medical Center; and William G. Nelson, M.D., Ph.D., of the Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins School of Medicine.

“Increasingly, scientific findings are indicating that changes in lifestyle-namely better nutrition and exercise routines-have an important effect on survivorship and prevention for many cancers. In some cases, it is now believed that intensive lifestyle intervention can provide a positive contribution to various medical interventions,” outlines Howard Soule, Ph.D., chief scientist for the Prostate Cancer Foundation. “We are grateful to Drs. Heber, Freedland, Jones and Nelson for their efforts in creating this publication. It provides important and useful information to prostate cancer patients and their families.”

The guide underscores the importance of a diet rich in fruits and vegetables and low in processed sugars and refined carbohydrates. It also calls for approximately 30 minutes of daily exercise. Healthier cooking techniques and hints for dining out are also provided.

Source
Prostate Cancer Foundation