Article Date: 06 Dec 2006 - 0:00am (PST) A new study in British Medical

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Purewire Launches Web Security-as-a-Service for Businesses
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?Today?s dynamic and interactive Web environment is the new threat vector of choice, and the security industry as a whole is a decade late in innovating ...
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Pharmalot

FDA advisers must abide by new financial limits
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Consumer Reports Investigation Reveals Government Among Biggest ...
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Sonnenschein Rebuilds Its IT Data Model
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Microsoft: Instant Messengers Connected by Less Than Seven People
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[PDF] Web 2.0: A New Wave of Innovation for Teaching and Learning? -
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Wikis, blogs and podcasts: a new generation of Web-based tools for virtual collaborative clinical … -
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Take Heart: Study Validates Folic Acid Decreases Risk Of Heart Disease And Stroke, Reinforces Animi-3 Formula

Article Date: 06 Dec 2006 - 0:00am (PST)
A new study in British Medical Journal reviews the scientific evidence published in previous studies that supports the use of folic acid as a way of reducing the risk of heart disease and strokes. Lead author and heart expert Dr. David Wald and colleagues clarify existing debate over the relationship between elevated homocysteine levels, a risk factor for heart disease, and folic acid supplementation:

"Since folic acid reduces homocysteine concentrations, to an extent dependent on background folate levels, it follows that increasing folic acid consumption will reduce the risk of heart attack and stroke by an amount related to the homocysteine reduction achieved. We therefore take the view that the evidence is now sufficient to justify action on lowering homocysteine concentrations."

Studies published in peer-reviewed journals have reported that patients with cardiovascular disease, diabetes, rheumatoid arthritis, and depression may be deficient in vital nutrients:

-- DHA (Omega-3)

-- Folic acid

-- Vitamin B6 and B12

Article continues below and (thank you)

Addressing these deficiencies may reduce cardiovascular risk.

"Animi-3 contains 1 mg of folic acid and 500 mcg of B12 which together have been associated with lowering homocysteine levels," said PBM Pharmaceuticals EVP Jack Schramm, inventor of the Animi-3 product. "Dr. Wald provides an encompassing review of studies and randomized trials that seem to show that folic acid consumption has a protective effect against heart disease. A cardiovascular risk reduction effect has also been previously attributed to omega-3 fatty acid consumption from marine sources, such as the omega-3 in Animi-3."

Animi-3 (http://www.animi-3.com) is a prescription product that contains highly refined DHA (omega-3), folic acid, vitamins B6 and B12. Animi-3 is indicated for improving nutritional status in conditions requiring DHA, (omega-3), folic acid, Vitamin B12, or B6 supplementation. Animi-3 is not intended to diagnose, treat, or cure any disease.

BMJ 2006;333;1114-1117

FDA "Qualified Health Claims" B vitamins & Vascular Disease. As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease. FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive. Docket No. 99P-3029.

PBM Pharmaceuticals, Inc.
http://www.animi-3.com

Semafore Granted Nearly One Million Dollars To Study SF1126 In Multiple Myeloma Patients

Semafore Pharmaceuticals, Inc. today announced receipt of a grant award from the Multiple Myeloma Research Foundation (MMRF) for a Phase l trial evaluating its Pl3K inhibitor SF1126 in multiple myeloma. This is the second clinical trial grant awarded to Semafore-last week the company announced receipt of a grant from Cancer Treatment Research Foundation (CTRF) to help fund a Phase l trial of SF1126 in solid cancers. Both Phase l trials are expected to commence in 2007. Separately, Semafore announced that multiple myeloma preclinical studies sponsored by the company and its collaborators at Emory University have been selected for an oral presentation at the upcoming 48th Annual Meeting of the American Society of Hematology (ASH.)

"This generous grant from the MMRF will enable us to rapidly initiate a clinical trial of SF1126 in multiple myeloma," said Dr. Joseph Garlich, president and chief scientist of Semafore. "The MMRF has an outstanding track record of funding innovative research that has significantly increased the treatment options available to myeloma patients. The PI3 kinase pathway plays a key role in the signaling processes that are vital to cancer cell proliferation, invasion and metastasis, yet there currently are no PI3K inhibitors in clinical trials. We are therefore delighted that both the MMRF and the CTRF have chosen to support cancer trials of our lead Pl3K inhibitor scheduled to begin in the new year."

The MMRF has awarded Semafore a $996,380 grant to help fund both the drug manufacturing and the patient costs of a Phase l trial in relapsed and refractory multiple myeloma patients. The grant award is from the new MMRF LEAD program designed to encourage myeloma clinical trials for promising new drugs being developed by young companies.

MMRF founder and chief executive officer Kathy Giusti noted, "Our mission is to accelerate the development of promising new drugs for myeloma, and Semafore's innovative approach that targets the Pl3 kinase pathway has shown significant promise in preclinical studies. There currently are no Pl3K inhibitors in clinical trials, so it is fitting that this promising new approach is one of the first recipients of our new LEAD clinical awards program."

The MMRF's LEAD program is a multi-year research grant commitment intended to drive and accelerate the development of innovative and effective multiple myeloma treatments by funding the development of lead compounds through the early stage drug development process that could have a significant impact on existing or future myeloma treatments.

Dr Garlich concluded, "The growing interest in the anti-cancer potential of our Pl3K approach is also highlighted by the fact that data from preclinical studies of SF1126 in myeloma were selected for an oral presentation at the upcoming ASH meeting, a noteworthy occurrence for a preclinical study."

SF1126 Oral Presentation at ASH: "A vascular targeted pan PI-3 kinase inhibitor, SF1126, with activity against multiple myeloma in vivo"

At the 48th Annual Meeting of the American Society for Hematology in Orlando, Florida, Dr. Donald L. Durden** will give an oral presentation of in vitro and in vivo preclinical data on SF1126 in multiple myeloma. Semafore has collaborated with Emory University to conduct these studies, with the financial support of the Multiple Myeloma Research Consortium (MMRC). The presentation is abstract # 244 scheduled for December 11, 2006 at 8:15 am EST in Chapin Theater (Level III).

Authors of the study include Pradip De, Qiong Peng, Nandini Dey, Breanne McDermitt, Sagar Lonial and Donald L. Durden from Emory University, and Xiaodong Peng and Joseph Garlich from Semafore Pharmaceuticals.

Professor of pediatric oncology and hematology at Emory University School of Medicine, scientific director of basic and translational research at the AFLAC Institute for Cancer and Blood Disorders, and chairman of Semafore's Scientific Advisory Board.

About Multiple Myeloma

Multiple myeloma is an incurable cancer of the blood plasma cell. The availability of a number of new drugs to treat myeloma is thought to be extending the lives of many patients, but the historical five-year survival rate for myeloma patients is only 32 percent. Approximately 50,000 people in the United States are living with multiple myeloma and an estimated 16,000 new cases are diagnosed each year. Although the peak age of onset of multiple myeloma is 65 to 70 years of age, recent statistics suggest that incidence is increasing and is also occurring at an earlier age.

About the Multiple Myeloma Research Foundation

The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)3 non-profit organization by twin sisters Karen Andrews and Kathy Giusti, a newly diagnosed multiple myeloma patient, with the unique mission of accelerating the search for a cure for multiple myeloma. Today, the MMRF is the largest non-profit foundation dedicated to the single mission of accelerating the search for a cure for multiple myeloma. As the world's number one funder of myeloma research, the MMRF has raised more than $70 million to fund more than 200 research grants at more than 70 research institutions around the globe. Currently, the MMRF is funding more than 30 new compounds and approaches -- in pre-clinical testing and Phase I, II and III clinical trials -- that show promise in treating patients at all stages of the disease. For more information about the MMRF, please visit http://www.multiplemyeloma.org.

About SF1126

SF1126 is a small molecule that selectively inhibits PI3K Class IA isoforms and other key members of the PI3K pathway such as DNA-PK and mTOR. Recent advances indicate that these targets play a critical role in the progression of cancer and many groups are searching for effective safe inhibitors of these targets. In preclinical studies, SF1126 has been shown to be a key regulator of many of the processes involved in tumor growth and dissemination. Preclinically, SF1126 inhibits angiogenesis, induces apoptosis, controls upstream and downstream signaling and produces synergistic anti-tumor effects in combination with chemotherapy and radiation. SF1126 has demonstrated promising activity in a variety of preclinical cancer models, including prostate, breast, lung, leukemia, multiple myeloma, brain and other cancers.

About Semafore

Semafore is an Indianapolis-based drug discovery and development company focused on small molecule modulators of the PI3 kinase (PI3K) and PTEN cell signaling pathway, one of the most promising target pathways for multiple disorders, including the company's focus, cancer. Semafore is one of the first biopharmaceutical companies to focus on both PI3K and PTEN and has successfully discovered and is developing a portfolio of drug candidates. The company expects to file an IND for its lead clinical candidate, PI3K inhibitor SF1126, in December of 2006. Semafore has also discovered the first drug-like small molecule PTEN modulators for cancer therapy, cell protection and therapeutic angiogenesis. For more information see the company's website at http://www.semaforepharma.com.

Semafore Pharmaceuticals
http://www.semaforepharma.com

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