Researchers Investigate Whether Mammastatin Protein Can Help Identify Women at Risk of Breast Cancer (dateline May 22, 2001)

A protein called mammastatin is being studied to determine whether it can help predict which women are likely to develop breast cancer. First identified in 1986, mammastatin is thought to be produced naturally by breast cells. Research has shown that the mammastatin protein may be absent or present in significantly lower than average levels in many breast cancer patients. Genesis Bioventures has announced plans to receive FDA regulatory approval to make a Mammastatin Serum Assay (MSA) test available at select laboratories in the United States. The MSA test would measure levels of mammastatin in healthy women to determine whether the test is accurate in determining breast cancer risk.

Supporters of the MSA test have likened it to the PSA test that is used to determine a man’s risk of prostate cancer. Paul Ervin, Jr., PhD first discovered the mammastatin protein while conducting research at the University of Michigan’s Cancer Center. Although much of Dr. Ervin’s research has not been conducted in an official clinical trial setting, Dr. Ervin believes that women with low levels of the mammastatin protein are at higher than average risk of developing breast cancer. According to Dr. Ervin’s research:

• Mammastatin is a protein produced by healthy women
• Mammastatin is thought to block breast cell growth
• Mammastatin may be missing or present in low levels in approximately 75% of breast cancer patients
• Mammastatin is non-toxic and is thought to only affect breast cancer cells

According to Genesis Bioventures, early clinical studies suggest that more than 85% of healthy women have relatively high levels of mammastatin in the blood while more than 75% of breast cancer patients have low levels or an absence of mammastatin. Initial studies also show that measuring a woman’s level of mammastatin may help reduce her fears of developing breast cancer since high levels of mammastatin have been shown to be associated with a lower risk of breast cancer.

While introducing the MSA test into the U.S. healthcare market will help further research into the possible benefits of mammastatin, the current research on mammastatin is preliminary. Mammastatin would not be used in the primary screening of breast cancer unless further data proved that it accurately predicted which women are likely to develop breast cancer.

Researchers also hope to investigate more aspects of the mammastatin protein including:

• Determining the mechanism of action of mammastatin
• Cloning the gene for mammastatin
• Finding proteins related to mammastatin that might be effective
  in treating other cancers
• Determining other ways to administer mammastatin
• Using mammastatin to help treat women who already have breast cancer

Currently, mammography is the only exam approved by the U.S. Food and Drug Administration (FDA) to help screen for women with no signs of breast cancer (such as a lump). Mammography has been shown to detect approximately 85% of all breast cancers. Physician performed clinical breast exams and monthly breast self-exams are also important in helping to detect breast cancer in early stages, when the chances for successful treatment and survival are the greatest.

Guidelines for early breast cancer detection:

• All women between 20 and 39 years of age should practice monthly breast self-exams and have physician performed clinical breast exams at least every three years.
• All women 40 years of age and older should have annual screening mammograms, practice monthly breast self-exams, and have yearly clinical breast exams. The clinical breast exam should be conducted close to and preferably before the scheduled mammogram.
• Younger women with a family or personal history of breast cancer should talk to their physicians about beginning annual mammograms before age 40.

Additional Resources and References

• The May 3, 2001 Genesis Bioventures press release, "Launching Blood Test Technology for Breast Cancer Risk Assessment," is available at http://www.genesisbioventures.com/
• The March 23, 2000 Imaginis report, "Mammastatin Protein Studied As Breast Cancer Treatment and Predictor," is available at http://www.imaginis.com/breasthealth/news/news3.23.00.asp
• To learn more about the early detection of breast cancer, please visit http://www.imaginis.com/breasthealth/earlydetection.asp