Studies Address Presence Of More Lethal Breast Cancer Among Black Women, Diet-Cancer Link

Black women are more likely to develop breast cancer tumors that are more advanced and more aggressive than white women, and biology is thought to be a major factor behind the disparity, according to a study published in the journal Cancer, the Bloomberg/Bergen Record reports (Zimm, Bloomberg/Bergen Record, 7/10).

For the study, researchers Edith Mitchell and Gloria Morris from Thomas Jefferson University Hospital's Kimmel Cancer Center examined more than 2,200 medical records of cancer patients seen at the hospital between 1990 and 2002. According to the study, white women were more likely to have tumors that contained estrogen or progesterone receptors -- known as HER2 -- and could be treated with available drugs, but black women's tumors were less likely to carry the treatable estrogen receptor. Tumors without such HER2 receptors are called triple-negative and can only be treated with chemotherapy.

In addition, the new study found that black women's tumors were more likely to have two molecular markers of aggressive spread and growth. According to the Inquirer, the finding could lead researchers to develop new targets to attack the more-aggressive tumors (Flam, Philadelphia Inquirer, 7/10). Morris said the reason behind the findings is "not necessarily related to socioeconomic and demographic differences," adding, "Now there is a strongly emerging biological basis that African-Americans are more likely to have more-aggressive tumors" (Bloomberg/Bergen Record, 7/10). She suggested further research on triple-negative tumors and the development of drugs to treat them (Philadelphia Inquirer, 7/10).


An abstract of the study is available online.

Diet-Cancer Link
In related news, two separate studies recently examined the link between diet and cancer among minorities. Summaries of news coverage on the studies appear below.
Chinese women and breast cancer: Postmenopausal Chinese women who consume a "Western-style" diet have a greater risk of developing breast cancer than those who consume traditional Chinese diets, according to a study published on Tuesday in the journal Cancer Epidemiology, Biomarkers & Prevention, Reuters reports. For the study, researcher Marilyn Tseng of the Fox Chase Cancer Center and colleagues tracked about 3,000 women in Shanghai, about half of whom were diagnosed with breast cancer. They found that those who consumed a Western-style diet -- beef, pork, shrimp, chicken, candy, desserts and dairy products -- were 60% more likely to develop breast cancer than those who ate mostly vegetables and soy products, which is typical of a Chinese diet. In addition, postmenopausal women consuming a Western-style diet had a 90% increased risk of a type of breast cancer involving estrogen-receptor positive tumors. The study's findings suggest that the Western diet might increase Chinese women's risk for breast cancer because of the added risk of obesity, Reuters reports (Dunham, Reuters, 7/10).














Racial disparities and diet: Diet might contribute to racial disparities between whites and blacks in terms of breast and prostate cancers, according to study published in the journal Ethnicity and Disease, Reuters Health reports. Minorities are more likely than whites to have less nutritious diets and to be overweight or obese, according to Reuters. For the study, researchers Hope Ferdowsian and Neal Barnard of the Physicians Committee for Responsible Medicine -- which promotes vegetarian diets -- examined previously conducted research on diet and cancer. In one study of 2,400 women who had been treated for breast cancer, researchers found that those instructed to follow a low-fat diet were about 25% less likely than others to have a cancer recurrence. In another study, breast cancer survivors who consumed a diet low in fat and high in fiber, fruits and vegetables experienced a decline in estrogen, while women who maintained their normal eating habits experienced a rise in estrogen, which can fuel tumor growth. According to the researchers, there is evidence that black women have relatively higher average levels of estrogen than white women. The findings also might explain why black men are more likely than white men to develop and die from prostate cancer, which also is driven by hormones, according to the study (Reuters Health, 7/9).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Schering's Contraceptive YAZ Receives 'Approvable Letter' From FDA, Pending Review Of Recent Data

Schering on Wednesday announced that it received an "approvable letter" from FDA for its oral contraceptive pill YAZ to treat premenstrual dysphoric disorder, a severe form of premenstrual syndrome, on the condition that the agency positively review recently submitted data on the drug's efficacy, Reuters reports (Reuters, 1/25). YAZ, which is manufactured by the Schering subsidiary Berlex, is a low-dose version of Schering's FDA-approved contraceptive pill Yasmin. YAZ contains ethinyl estradiol and drospirenone and is taken once a day for 24 days followed by four days of placebo to induce a menstrual period. Most oral contraceptives are taken for 21 consecutive days followed by seven days of placebos. FDA in November 2004 sent an approvable letter to Berlex for YAZ to be used as a contraceptive, and the company expected to receive final approval for sales of the pill by the end of 2005 (Kaiser Daily Women's Health Policy Report, 12/12/05). According to Reuters, YAZ has not yet been approved by FDA for use as a contraceptive (Reuters, 1/25). The company in a release said FDA has not requested additional clinical studies on the drug for use to treat PMDD, adding that it expects final approval by the end of the first quarter of 2006 (Schering release, 1/25). "It is a message from the FDA saying that they need more time," a Schering spokesperson said (Reuters, 1/25).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


View drug information on Estradiol Transdermal System.

Fat Is The New Normal, FSU Researcher Says - Changing Perceptions Of Body Weight Feed Rise In Obesity

American women have gotten fatter as it has become more socially acceptable to carry a few extra pounds, according to a new study. Florida State University Assistant Professor of Economics Frank Heiland and Federal Reserve Bank of Boston Economist Mary Burke are the co-authors of a paper published in the academic journal Economic Inquiry that argues that the ballooning weight of the population has fed even more collective weight gain as our perception of what is considered a normal body size has changed.


? ? ? ? "This is a social force that we are trying to document because the rise in obesity has occurred so rapidly over the past 30 years," said Heiland, who also is affiliated with FSU's Center for Demography and Population Health. "Medically speaking, most agree that this trend is a dangerous one because of its connection to diabetes, cancer and other diseases. But psychologically, it may provide relief to know that you are not the only one packing on the pounds."


? ? ? ? The paper, "Social Dynamics of Obesity," is the first to provide a mathematical model of the impact of economic, biological and social factors on aggregate body weight distribution. It also is one of the first studies to suggest that weight norms may change and are not set standards based on beauty or medical ideals.


? ? ? ? Many economists believe that people eat more -- and thus gain weight -- when food prices drop, but that's just part of the story behind the nation's dramatic weight gain since the late 1970s, according to the researchers. The full price of a calorie has dropped by about 36 percent relative to the price of consumer goods since 1977, but prices leveled off in the mid-1990s. And yet American women continued to get bigger.



Heiland and Burke's "social multiplier" theory offers a potential reason why: As Americans continue to super-size their value meals, the average weight of the population increases and people slowly adjust their perceptions of appropriate body weight. Given that these changes in perception may come about gradually, Heiland and Burke suggest the nation's battle of the bulge may extend into the future.



Heiland and Burke studied body weights among American women in the 30- to 60-year-old age bracket from 1976 to 2000. Using data from the National Health and Nutrition Examination Survey, they found that the weight of the average woman increased by 20 pounds, or 13.5 percent, during that period. There was disproportionate growth among the most obese women as the 99th percentile weight increased a hefty 18.2 percent, from 258 to 305 pounds.



The researchers also looked at self-reports of women's real weights and desired weights. In 1994, the average woman said she weighed 147 pounds but wanted to weigh 132 pounds. By 2002, the average woman weighed 153 pounds but wanted the scales to register 135 pounds, according to data from the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System.



The fact that even the desired weight of women has increased suggests there is less social pressure to lose weight, Heiland said, citing a previous study that 87 percent of Americans, including 48 percent of obese Americans, believe that their body weight falls in the "socially acceptable" range.



While it seems thinness is increasingly idealized in popular culture -- images of waif-like models and stick-thin celebrities are everywhere -- there is a gap between the cultural imagery and the weights that most people consider acceptable for themselves and others, according to Heiland.



Biological forces also play a role in the rise of obesity. An additional pound of body weight is more likely to be fat, which does not metabolize calories nearly as well as muscle tissue, Heiland explained. Therefore, any increase in calorie consumption -- say, one more cookie each day -- leads to greater weight gain among an initially heavier person.



The researchers focused this study on women partly because their weight gains have been so dramatic, Heiland said, citing a whopper of a statistic: 33.2 percent of American women over age 20 are classified as obese, according to 2001-2004 National Health and Nutrition Examination Survey data. However, men also have become heavier, and the researchers believe the same economic, social and biological forces are to blame.



Florida State University

Callisto Announces Sponsored Laboratory Study Agreement With M. D. Anderson Cancer Center On Degrasyn Anticancer Agents

Pharmaceuticals,
Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fight
against cancer and other major health threats, announced today that a
sponsored laboratory study agreement has been executed with The University
of Texas M. D. Anderson Cancer Center to support development of the
Company's Degrasyn class of cancer-fighting compounds.


The two-year agreement is intended to support in-vitro and animal model
studies to be performed by a group of research scientists at M. D.
Anderson, who will focus on evaluating Degrasyn analogs being synthesized
under the auspices of a separate executed sponsored laboratory study
agreement with M. D. Anderson.


Callisto recently licensed the Degrasyn class of compounds, formerly
referred to as tyrphostins, from The University of Texas M. D. Anderson
Cancer Center, a leading center devoted to cancer patient care and
research. The novel anti-cancer activity of Degrasyns relates to their
ability to selectively promote degradation of key proteins involved in
tumor growth and survival.


"The planned research by M. D. Anderson scientists, where the Degrasyn
class of drugs was initially developed, provides an exciting opportunity to
advance the Degrasyn program towards the clinic," said Dr. Donald Picker,
Callisto's Executive Vice President of Research and Development. "This
program is a high priority activity at Callisto which we hope could yield
an important new tumor-fighting drug to treat a variety of cancers."


Dr. Nicholas J. Donato, associate professor in the Department of
Experimental Therapeutics, at M. D. Anderson will serve as principal
investigator on the program, formally titled, "Analysis of the Anti-Tumor
Activity and Mechanism of Action of WP1130 and its Analogs."


"We are working closely with Callisto and with my colleague at M. D.
Anderson, Dr. William Bornmann and his associates, to evaluate a library of
synthesized Degrasyn analogs utilizing state-of-the-art biological assays,"
said Dr. Donato. "We also are continuing to explore the unique
mechanism-of- action elicited by this interesting class of compounds."


About Callisto Pharmaceuticals, Inc.


Callisto is a biopharmaceutical company focused on the development of
new drugs to treat various forms of cancer and other serious afflictions.
Callisto's drug candidates in development currently include anti-cancer
agents in clinical development, in addition to drugs for other significant
health care markets, including ulcerative colitis and biodefense. One of
the Company's lead drug candidates, L-Annamycin, is being developed as a
treatment for forms of relapsed acute leukemia, a currently incurable blood
cancer. Callisto initiated a clinical trial of L-Annamycin in adult
relapsed acute lymphocytic leukemia patients in 4Q 2005. L-Annamycin, a new
compound from the anthracycline family of proven anti-cancer drugs, has a
novel therapeutic profile, including activity against resistant diseases
and significantly reduced cardiotoxicity, or damage to the heart, compared
to currently available drug alternatives. Another anti-cancer drug,
Atiprimod, is in development to treat relapsed multiple myeloma, a blood
cancer, and advanced carcinoid cancer. Atiprimod is presently in Phase
I/IIa human clinical trials in relapsed multiple myeloma patients, and
advanced cancer patients, respectively. Callisto also has drugs in
preclinical development for gastro- intestinal inflammation, and a program
focused on the development of a drug to protect against Staphylococcus and
Streptococcus biowarfare agents. Callisto has exclusive worldwide licenses
from AnorMED Inc. and The University of Texas M. D. Anderson Cancer Center
to develop, manufacture, use and sell Atiprimod and L-Annamycin,
respectively. Callisto is also listed on the Frankfurt Stock Exchange under
the ticker symbol CA4. For additional information, visit
callistopharma .















Forward-Looking Statements


Certain statements made in this press release are forward-looking. Such
statements are indicated by words such as "expect," "should," "anticipate"
and similar words indicating uncertainty in facts and figures. Although
Callisto believes that the expectations reflected in such forward-looking
statements are reasonable, it can give no assurance that such expectations
reflected in such forward-looking statements will prove to be correct. As
discussed in the Callisto Pharmaceuticals Annual Report on Form 10-K/A for
the year ended December 31, 2005, and other periodic reports, as filed with
the Securities and Exchange Commission, actual results could differ
materially from those projected in the forward-looking statements as a
result of the following factors, among others: uncertainties associated
with product development, the risk that products that appeared promising in
early clinical trials do not demonstrate efficacy in larger-scale clinical
trials, the risk that Callisto will not obtain approval to market its
products, the risks associated with dependence upon key personnel and the
need for additional financing.


Callisto Pharmaceuticals, Inc.

callistopharma

FDA Issues Approvable Letter To Cellegy Pharmaceuticals For Cellegesic(R)

Cellegy
Pharmaceuticals, Inc. (OTC Bulletin Board: CLGY.OB) announced that it
received late afternoon on Friday, July 7 a communication from the U.S.
Food and Drug Administration in the form of an Approvable Letter for its
product, Cellegesic(R) (nitroglycerin ointment). The letter stated,
however, that before the company's New Drug Application (NDA) may be
approved and the product approved for marketing, Cellegy must conduct
another clinical trial to demonstrate efficacy at a level deemed
statistically significant by the agency. The letter indicated that the
agency was requiring an additional study because it believed the results of
the three trials conducted to date did not provide substantial evidence
that the drug is effective, and provided a number of comments on the
results previously presented by Cellegy and recommendations concerning the
design and protocol of the additional required study. Cellegesic, for the
treatment of anal fissures, was the subject of an FDA Not Approvable letter
in December 2004. An amended NDA, containing new analyses, was resubmitted
to the FDA in April 2005, which resulted in a review by the FDA's
Cardio-Renal Advisory Committee in April 2006. As previously reported, the
Advisory Committee's final vote was six members of the Committee for
"Approval" of Cellegesic and six for "Approvable pending another study of
effectiveness." There were no votes for "Not Approvable." Cellegesic has
been under review at the FDA since then.


Richard C. Williams, Cellegy's Chairman and interim CEO, stated, "We
believe that we achieved the requirements for Cellegesic to be approved.
The FDA reached a different conclusion that the product was approvable, but
requires another trial to demonstrate efficacy. We are carefully
considering all of our options and will be scheduling a meeting with the
FDA."


Conference Call Information


Cellegy will be hosting a conference call beginning at 1:00 p.m.
Eastern Daylight Time (10:00 a.m. Pacific Daylight Time) today, Monday,
July 10, 2006. Richard C. Williams, Chairman and interim CEO, will provide
an update. To participate in the live call by telephone, please dial (866)
700-5192 from the United States, or for international callers, please dial
(617) 213-8833, entering the Passcode, 11193554.


A replay will be available on Cellegy's website for one week. A
telephone replay will be available for one week by dialing (888) 286-8010
from the United States, or (617) 801-6888 for international callers, and
entering Passcode 30080567.



About Cellegy


Cellegy Pharmaceuticals is a specialty biopharmaceutical company that
develops and commercializes prescription drugs for the treatment of women's
health care conditions, including sexual dysfunction, HIV prevention and
gastrointestinal disorders. Savvy(R) (C31G vaginal gel), a novel
microbicide gel product for contraception and the reduction in transmission
of HIV in women, is currently undergoing Phase 3 clinical studies in the
United States and Africa.


Forward Looking Statements


This press release contains forward-looking statements. Investors are
cautioned that these forward-looking statements are subject to numerous
risks and uncertainties, known and unknown, which could cause actual
results and developments to differ materially from those expressed or
implied in such statements. Such risks and uncertainties relate to, among
other factors: the company's cash position and need and ability to complete
corporate partnerships and additional financings; market acceptance and the
level of future sales of Rectogesic(R) markets outside the United States;
and completion, timing and outcome of clinical trials, including primarily
the Savvy prevention and contraceptive Phase 3 studies. For more
information regarding risk factors, refer to the Company's Annual Report on
Form 10-K for the year ended December 31, 2005 and other filings with the
Securities and Exchange Commission.


Cellegy Pharmaceuticals, Inc.

cellegy