This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study. The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year. Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk ...

Genomic Health Inc. (GHDX) suffered a third quarter loss of 2 cents per share, which was better than the Zacks Consensus Estimate of a loss of 9 cents. The company suffered a loss of 11 cents in the prior-year period.   Total revenues for the quarter came in at $39.5 million, compared with $28.1 million in the third quarter of 2008, up 40.6%. Product revenues from the Oncotype DX breast cancer test increased 39% to $38.9 million, compared with $28.1 million in the comparable quarter of 2008. Contract revenues accounted for the balance. In the third quarter, Genomic Health delivered in excess of 12,600 test results, compared with more than 10,220 test results in the comparable period of 2008, representing approximately a 23% year-over-year growth.   Research and development spend for the third quarter increased 31.9% to $9.1 million, compared to $6.9 million in the same period in ...

Rosetta Genomics (NASDAQ:ROSG) today announced an update regarding their colon cancer diagnostic program and said that Ayelet Chajut, Executive Vice President, R&D, Head of Molecular Biology will speak more about this program at the 6th International Conference on Circulating Nucleic Acids in Plasma and Serum (CNAPS-VI). The conference will held from November 9 to November 11 in Hong Kong where they will present a new generation of molecular diagnostic markers that will help in the treatment and diagnosis of colon cancer. Rosetta Genomics is one of the leading molecular diagnostics companies that develops and commercializes molecular diagnostic products based on its proprietary microRNAs. The company is also developing and discovering early detection cancer screening products, including a colon cancer screening test. Rosetta Genomics have their labs in Philadelphia where they perform commercial molecular diagnostics tests in order to discover and develop new diagnostics markers.

During the update, Rosetta Genomics pointed

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BEVERLY, Mass., Oct. 19, 2009 (GLOBE NEWSWIRE) — Cellceutix Corporation (OTCBB:CTIX) today announced that data recently presented by the Company at the American Association for Cancer Research (AACR) along with other data developed by the Company indicate that Kevetrin is selectively targeting very specific anti-tumor pathways, such as AKT and p38 MAP kinase. The data presented at the AACR showed that Kevetrin was less cytotoxic than paclitaxel, cisplatin and 5FU while having better anti-tumor activity in two multi-drug resistant lung cancer cell lines. This indicates that Kevetrin is not acting primarily as a cytotoxic agent but may be targeting specific components of the signal transduction pathway, such as AKT and p38 MAP kinase. The Company is continuing to explore other potential targets.

Other data developed by the Company indicate that Kevetrin has potent anti-tumor activity in one cell line (MDA-MB–231) despite only partially inhibiting AKT in that cell line.

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Recently, Genomic Health Inc. (GHDX) announced data which confirmed that manual micro dissection (dissection of tissue or cells under the microscope) of biopsy cavities is essential for the accurate assessment of recurrence risk in patients with early-stage breast cancer.  Genomic Health's Oncotype DX is the only commercially available breast cancer test that makes use of manual microdissection following review by a board certified surgical pathologist with expertise in breast cancer to predict a patient's benefit from chemotherapy and risk of disease recurrence.  The results from the study revealed that the inclusion of biopsy cavities in breast cancer specimens is associated with significant changes in the expression of individual genes. Consequently, it was found that biopsy cavities had high-risk Recurrence Scores.  Genomic also presented results which demonstrated ability of Oncotype DX breast cancer test to predict the likelihood of disease recurrence in Japanese women with estrogen ...

Kevetrin(TM) Shows Excellent Activity in Animal Models of Drug Resistant Lung Cancer With Less Cytotoxicity Than Paclitaxel

Cellceutix of Beverly, MA, to Pursue Development for Drug-Resistant Lung Cancer

BEVERLY, Mass., Oct. 13, 2009 (GLOBE NEWSWIRE) — Cellceutix Corporation (OTCBB:CTIX) today announced that it presented a poster and its Chief Scientific Officer, Dr. Krishna Menon, was one of only four individuals selected to participate in an expert panel discussion of the abstract at the American Association for Cancer Research (AACR) meeting “Frontiers in Basic Cancer Research” in Boston, MA on October 10, 2009. The Company’s poster describes in vitro and in vivo research on its lead compound, Kevetrin(TM), which is being developed for drug resistant cancers. The three day AACR meeting featured presentations on the latest advances in basic cancer research from around the world. The AACR issued a press release on October 10, 2009 which featured the abstract submitted

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Companies featured in this edition of the newsletter: ACTC, CHIP, CUR, CVM, ENZ, IMUC, IWEB, SRCO, SVUL, XSNX

Markets finally snapped their winning streak last week, as weakness in housing markets and durable goods orders led to broad-based declines in all of the major indices. All told, the Dow surrendered 155 points on the week to close at 9665, down 1.6% on the week but up 10.1% on the year. The Nasdaq lost 2.0% on the week to close at 2090, up 32.6% on the year, while the S&P 500 and Russell 2000 posted losses of 2.2% and 3.1% respectively, paring their yearly gains to 15.6% and 19.9%.

Unexpectedly poor data from the housing sector was the big economic story on the week as both new and existing August home sales failed to live up to expectations. New home sales increased modestly to 429,000, falling short of estimates calling

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Yesterday, Bristol-Myers Squibb (BMY) released inconsistent results for its colon cancer drug Erbitux (cetuximab) from two late-stage studies. Among the two retrospective analyses of the pivotal phase III studies, CRYSTAL and COIN, one reported positive results while the other failed to meet its primary end point. Erbitux is sold by Merck KGaA, Eli Lilly (LLY) and Bristol-Myers Squibb.

CRYSTAL is a multi-national study conducted by Merck KGaA. Erbitux, when added to Folfiri (a chemotherapy regimen) increased median overall survival to 19.9 months in an intent-to-treat population of first-line metastatic colorectal cancer (mCRC) patients compared to 18.6 months in the recipients of Folfiri only.

Moreover, when studied in a subset of mCRC patients with normal or wild-type version of a gene called KRAS, the median overall survival increased to 23.5 months in patients who received Erbitux plus Folfiri as against 20 months for those who took Folfiri alone.

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Yesterday, Genomic Health, Inc. (GHDX) announced that a number of leading U.S. surgeons ask for Genomic Health's Oncotype DX breast cancer assay at the time of surgery or biopsy, in an effort to provide patients with prompt, critical information about treatment options available at their maiden visit to an oncologist. Oncotype DX, the growth engine of the company, was launched in 2004. It is the first and only multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In late May 2009, Genomic Health announced that more than 100,000 test results have been delivered in over 40 countries worldwide since the commercial launch of Oncotype DX. The assay analyzes the activity of 21 genes within a breast cancer patient's tumor to calculate an individualized result (Recurrence Score). Upon ...

Yesterday, patient enrollment (1200) for a phase III trial of ASA404, jointly developed by Novartis (NVS) and Antisoma for the treatment of non small-cell lung cancer (NSCLC) was completed. Novartis is conducting the trial as the development and commercialization partner (for ASA404) of Antisoma. The trial will be conducted to test the effectiveness of the drug as a first-line treatment for squamous and non-squamous NSCLC with results due in 2010 or early 2011. The company expects to file for approval in 2011 if the trial results are positive. In addition to this, Novartis will be conducting another study of the drug in previously treated patients. Lung cancer kills 1.3 million people a year and is one of the leading causes of cancer death across the world. NSCLC accounting for about 87% of all lung cancer patients is one of the leading causes of death. Survival rates ...