Zetiq, a subsidiary of Bio-Light Ltd. (TASE:BOLT), reports the successful completion of a clinical trial to validate feasibility of early identification of cervical cancer.

The trial was conducted on cervical smears collected from 74 subjects at Meir MC and Macabbi health services in Israel. The collected samples were processed with the advanced liquid based cytology method, and examined using 3 methods: staining with the traditional widely used Pap method, testing to identify the presence of the HPV virus that causes the disease, and staining with the Zetiq method. The analysis of the specimens was conducted by the company’s team as well as by an independent professional.

According to the results of the trial, the testing utilizing company’s CellDetect™ technology has an average sensitivity of 90% to track and identify pre cancerous (dysplastic) cells, and a specificity of 74%. This mentioned sensitivity was found to be higher then the sensitivity of the traditional Pap test, routinely used today with over 300 million tests conducted world wide, and similar to that of the test for HPV, the virus that can under certain circumstances cause the disease. The specificity of the company’s test was similar to that of the Pap test and significantly higher then that of the HPV test.

Dr. Adi Elkeles, CEO of Zetiq Technologies Ltd says: “we have successfully completed this important milestone which demonstrates the company’s ability to develop a simple and effective diagnostic tool for early identification of cervical cancer.”

“The results of this trial complement the previous successful trial completed earlier this year for the identification of cervical cancer in Biopsies. The combined results show that Zetiq has complementary products able to screen as well as diagnose cervical cancer, offering high detection accuracy with a cost effective process. These clinical findings attest to the range of applications for the company’s technology,” adds Dr. Elkeles.

Cervical cancer is the second leading cause of cancer in women world wide. Early identification of the disease greatly increases the survival rate.

The screening methods currently available for the disease have succeeded in reducing mortality rate in the Western world, where performed, but their error rate is high and the cost of follow up tests is substantial. To note, the error rates of the Pap test in screening reach 30-50%.

There are also tests currently available to identify the HPV virus, which can cause the disease. These tests are not specific as most women that carry the virus do not develop cervical cancer, thus tests that identify the virus do not solve the need for a reliable screen test.

Screen tests for cervical cancer are performed routinely in the western world, and in spite of their draw backs have a large market that in the US alone reaches above 1.5 Billion dollars. In developing countries there is no effective screening test available today to identify cervical cancer.

Dr. Ami Eyal - CEO of Bio-Light: “The results of this trial confirm that Zetiq has the potential to develop novel and effective products for early diagnosis of cervical cancer and probably other indications. The company plans to complete the development of its product for screening to early identify cervical cancers, and to proceed towards international collaborations and product commercialization.”

Source
Zetiq Technologies Ltd.

Affymax, Inc. (Nasdaq:AFFY) today announced data from a post hoc analysis of 120 patients in a Phase 2 clinical trial of Hematide™ in non-dialysis chronic kidney disease (CKD) patients. The data suggest that there is no major impact of baseline renal function as measured by Estimated Glomerular Filtration Rate (eGFR) on the monthly Hematide dose required to increase and maintain hemoglobin (Hgb) values within target range in non-dialysis CKD patients. The data were presented by Iain C. Macdougall, M.D. at the World Congress of Nephrology meeting being held in Milan, Italy.

“As Hematide is partially excreted by the kidneys, it was imperative to evaluate whether renal function affected the product’s ability to achieve hemoglobin target ranges,” said Dr. Macdougall, consultant nephrologist in the Department of Renal Medicine at King’s College Hospital in London. “These data suggest that Hematide results in appropriate management of hemoglobin levels in a broad spectrum of patients with CKD, regardless of baseline renal function. Anemia is a pervasive problem in the chronic kidney disease patient population. Being able to manage and control anemia allows treating physicians to focus attention on management of the patient’s underlying renal disease.”

The post-hoc analysis included data from an open-label Phase 2 study of 120 patients with stage 3, 4 or 5 CKD. The analysis suggests that mean Hgb increased approximately 2 g/dL by three months (from approximately 10 g/dL to approximately 12 g/dL) and remained stable for five months across all CKD groups, regardless of baseline eGFR. In addition, Hematide doses were similar across all CKD groups regardless of baseline eGFR. Twelve patients (10%) reported an adverse event considered possibly related to treatment. Adverse events occurring in more than one patient included arthritis (2), headache (2), and hypertension (7). One serious adverse event, an embolic cerebral infarction, was considered possibly related to study drug. The study was not specifically designed to evaluate the effect of renal function on Hematide dose and therefore caution should be exercised in the interpretation of results.

Anne-Marie Duliege, M.D., chief medical officer for Affymax added, “This is an encouraging post hoc analysis that warrants further evaluation. Hematide’s ability to increase hemoglobin in a broad spectrum of chronic renal failure patients is the subject of our ongoing Phase 3 clinical trials. We will continue to generate data which we believe will assist physicians in optimizing anemia management in their patients.”

About Hematide

Hematide is a synthetic, peptidic erythropoiesis stimulating agent (ESA) linked to polyethylene glycol (PEG) that is being developed for the treatment of anemia associated with chronic renal failure.

Affymax and Takeda are collaborating on the development of Hematide and plan to co-commercialize the product in the United States. The product, upon approval, will be commercialized in the European Union by Takeda. Affymax is conducting Phase 3 clinical trials for Hematide to treat anemia associated with chronic renal failure.

Source
Affymax, Inc.

Synergy Pharmaceuticals, Inc. (OTC BB: SGYP.OB SGY PNews), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that clinical data from the Phase I healthy volunteer study of SP-304, a new member of a class of investigational drugs for the treatment of irritable bowel syndrome with constipation (IBS-C), and chronic idiopathic constipation (CIC), will be presented at the Digestive Disease Week (DDW) annual meeting to be held in Chicago, IL from May 30 through June 4, 2009.

The poster presentation entitled: “A Randomized, Double-blind, Placebo-Controlled, Single-, Ascending-, Oral-Dose Safety, Tolerability and Pharmacokinetic Study of SP-304 in Healthy Adult Human Male and Female Volunteers” by Kunwar Shailubhai, Ph.D., William A. Gerson, D.O., Craig Talluto, Ph.D. and G.S. Jacob, Ph.D. will be on Wednesday, June 3 from 8:00 am to 5:00 pm in the South Hall (McCormick Place).

About SP-304

SP-304 is a member of a new class of non-systemic drugs for treatment of chronic constipation (CC), irritable bowel syndrome with constipation (IBS-C) and other GI diseases. SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered SP-304 binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut, facilitating bowel movement. In animal models, oral administration of SP-304 promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.

About Irritable Bowel Syndrome

Up to one sixth of adults experience inflammatory bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The split in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 million people in the US and an additional 10 million people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.

About Chronic Constipation

Chronic constipation is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating relief. The prevalence of the disorder is similar in other developed countries. Patients with chronic constipation often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.

Source
Synergy Pharmaceuticals, Inc.