Tarix Pharmaceuticals : TXA127 Granted Orphan Drug Status for Treatment of Pulmonary Arterial Hypertension

September 27, 2011 – Tarix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted TXA127, the Company’s lead peptide drug candidate, orphan drug status for the treatment of pulmonary arterial hypertension (PAH). Emerging science has demonstrated that the naturally occurring peptide angiotensin (1-7), the pharmaceutical ingredient in TXA127, exhibits a protective effect in animal models of PAH, suggesting a potentially beneficial role for TXA127 against this disease.

 Rick Franklin, M.D., Ph.D., Chief Executive Officer of Tarix, commented, “We are extremely pleased that TXA127 has been granted orphan drug status for this indication by the FDA. This is an important development for Tarix and is part of our strategy to build a portfolio of products using TXA127 and our synthetic peptide PanCyte to treat a variety of serious pulmonary diseases.”

 Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation and acute respiratory distress syndrome (ARDS). In 2010, TXA127 was granted Orphan Drug designation as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS)... Tarix Pharmaceuticals' Press Release -

ABI (Akers Biosciences, Inc.) Starts Clinical Trials for Breath PulmoHealth “Check” Rapid Assay

24 August 2011 - Akers Biosciences, Inc. (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce that clinical trials (the “Trials”) have commenced for the COPD version of the Company’s Breath PulmoHealth Check suite of rapid testing products. The Trials, which are being conducted in Clearwater, Florida (USA), will comprise at least 200 subjects with early- and late-stage chronic obstructive pulmonary disease (COPD), and the individuals will vary in the level of control of their disease. The protocol is designed to provide the clinical data needed to support regulatory submissions in the USA and EU in H1 2012.

 The Breath PulmoHealth “Check” COPD detector (“COPD detector”) identifies biomarkers that signal the breakdown of lung tissue in patients with COPD. Smoking is the leading cause of COPD, but exposure to second-hand smoke, pollution, and certain gases or fumes can also be causative factors leading to this chronic pulmonary condition. Globally, approximately 210 million individuals are being treated for COPD, but each of the 1 billion smokers is at risk for the disease... [PDF] Akers Biosciences' Press Release -

Aethlon Medical : Sarcoma, Lung Cancer, Prostate Cancer, Metastatic Melanoma, and Head and Neck Cancer Studies

Aug. 24, 2011 -- Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that it has entered into an agreement with the Sarcoma Oncology Center to study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. Exosomes released by cancer have recently emerged as a novel therapeutic target in cancer care, as they have been implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes may assist tumors in evading the response of the immune system. At present, there is no therapeutic drug candidate to inhibit the deleterious roles of cancer-released exosomes. The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including HIV and Hepatitis C virus. The device has also demonstrated the ability to capture cancer-released exosomes from cell culture and human ascites fluids [...]

 "The opportunity to test the ability of our Hemopurifier® to remove exosomes from the blood of cancer patients represents an important step in our effort to improve cancer care," stated Aethlon Chairman and CEO, Jim Joyce. "Additionally, we will have the privilege of working with Dr. Sant Chawla, a leading authority in the sarcoma oncology field and his team at the Sarcoma Oncology Center."

 The study will be conducted in collaboration with The Sarcoma Oncology Center based in Santa Monica, California. The Sarcoma Oncology Center is one of the most sought after research centers for the clinical testing of new therapeutic candidates against sarcomas and other forms of cancer. [...] The lead investigator of the study is Dr. Sant P. Chawla (About Dr. Chawla). Dr. Chawla noted, "This clinical histological study is a critical validation step in Aethlon's Hemopurifier® strategy for cancer that we hope will set the stage for planned therapeutic trials in cancer patients. The concept of 'subtractive therapy', eliminating a major mechanism of tumor progression and resistance to drugs, represents a potential breakout solution that needs to be tested in the clinic." The initial study will quantitate and capture exosomes ex-vivo, from blood samples of patients with advanced cancers. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma... Aethlon Medical's Press Release -

Helsinn : Global Pivotal Phase III Clinical Program to Evaluate Anamorelin in Non-Small Cell Lung Cancer-Associated Anorexia/Cachexia

Aug. 23, 2011 -- Helsinn, a Swiss-based pharmaceutical company, announced that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).

The anamorelin clinical program includes two pivotal Phase III studies to be run in parallel, named ROMANA-1 and ROMANA-2. Each is a randomized, double-blind, placebo controlled, multicenter global trial that is expected to enroll up to 477 patients. In addition, patients will have the option of continuing treatment in a 12-week safety extension study called ROMANA-3. The primary efficacy endpoints of ROMANA-1 and 2 include a measure of difference in the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss. Pharmacokinetic and additional safety measures will also be evaluated... [PDF] Helsinn's Press Release -