Phase I trial of novel HER2/neu Antigens will Start at Mayo; Isis Initiates Phase 2 Study of ISIS-APOCIIIRx Print E-mail
By Staff and Wire Reports   
Friday, 04 May 2012 18:39
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 4, 2012.

TapImmune Inc. (OTCBB: TPIV)
has announced that following recent IRB approval a Phase I Clinical Trial on a novel set of HER2/neu Class II antigens will start at Mayo Clinic, Rochester MN.  Mayo Clinic received IND allowance from the FDA for this trial in 2011.  TapImmune is sponsoring the Phase I study and has an Exclusive Option to License the antigen technology at the end of Phase I.  Following an overwhelming response from breast cancer patients wishing to be part of this trial, Mayo anticipates the initial patient recruitment to be fully subscribed. The study will have an interim safety analysis that will examine safety after 5 patients have been enrolled and received a single cycle of treatments.

These proprietary antigens were discovered by Keith Knutson Ph.D. and colleagues using a series of computer based predictions followed by testing of breast cancer patient responses to the predicted target peptides.  Importantly this immune response data indicates that these antigens are naturally processed and that tolerance to these self-antigens is not a limiting factor. The peptides show high affinity binding to human MHC proteins for 84% of the population, making this potentially applicable to a wider spectrum of patients when compared to other HER-2/neu vaccine compositions.

The Phase I trial will be carried out in breast cancer patients who finished standard Herceptin(r)- based therapy and are at a high risk of disease recurrence.

The primary endpoints of the study will be safety and immunogenicity.  This study represents the first step in the clinical development of TapImmune's HER-2/neu vaccine program, with follow on studies adding TAP expression and additional class I target peptides in a 'prime and boost' approach being the ultimate goal.  It is, therefore, a major milestone for
the Company.


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Isis Pharmaceuticals, Inc. (NASDAQ: ISIS)
announced the initiation of a Phase 2 study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia. Hypertriglyceridemia, a condition characterized by high levels of triglycerides, is often associated with premature coronary artery disease and pancreatitis. Patients with severe hypertriglyceridemia often cannot control their triglyceride levels with existing medicines. ISIS-APOCIIIRx lowers triglycerides by reducing the protein, apoC-III. Both triglycerides and apoC-III are independent risk factors for cardiovascular disease.

Isis is pursuing a staged development plan for ISIS-APOCIIIRx designed to shorten the time to bring this medicine to patients at high-risk of cardiovascular disease and pancreatitis. ISIS-APOCIIIRx is the third drug to advance into Phase 2 clinical studies from Isis' cardiovascular franchise. In this franchise, Isis is creating a suite of drugs targeting each of the atherogenic lipid components of cardiovascular disease to allow lipidologists to tailor treatment for the particular combination of lipid disorders that affect each individual patient.



Also Friday:



Accentia Biopharmaceuticals, Inc. (OTCQB:ABPI)
today announced that the Company and leading physicians from Johns Hopkins University co-hosted a meeting with prospective clinical trial investigators at the recent American Academy of Neurology (AAN) Annual Meeting in New Orleans.

At the 2012 Thrombosis and Hemostasis Summit of North America, Alere Inc. (NYSE: ALR) announced preliminary results from the largest study to date comparing warfarin (Coumadin®) and dabigatran (Pradaxa®) therapies administered in a real-world setting.

Anacor Pharmaceuticals (NASDAQ:ANAC)
will release its financial results for the quarter ended March 31, 2012, on Thursday, May 10, 2012 at approximately 4:00 p.m. ET / 1:00 p.m. PT.

Cannabis Science, Inc. (OTCBB: CBIS.ob)
, a pioneering U.S. biotech company developing pharmaceutical cannabis products, supports House Minority Leader Nancy Pelosi D-San Francisco Historic Statement to President Obama supporting Medical Cannabis and the Fight for Patient Rights.

Columbia Laboratories, Inc. (Nasdaq: CBRX)
today reported financial results for the three-month period ended March 31, 2012.

Forest Laboratories, Inc. (NYSE: FRX)
today announced it will be presenting data on two late-stage development products, cariprazine and levomilnacipran, at the American Psychiatric Association (APA) Annual Meeting scheduled May 5-9, 2012 in Philadelphia, PA.

iCAD, Inc. (Nasdaq: ICAD)
, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, and Breastlink Medical Group in Southern California, today announced an agreement that will make the Xoft® Axxent® Electronic Brachytherapy System® available to breast cancer patients treated at Breastlink.

IGI Laboratories, Inc. (NYSE Amex: IG), a New Jersey based topical generic drug development and manufacturing company, will hold a conference call at 4:15 pm ET on Tuesday, May 15, 2012 to discuss 1st quarter 2012 results.

Origin Agritech Limited (NASDAQ: SEED) (“Origin” or the “Company”), a technology-focused supplier of hybrid and genetically modified crop seeds in China, today announced that the Company will report results for its fiscal year 2012 second quarter ended March 31, 2012, before the market opens on Tuesday, May 8, 2012.

Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 randomized withdrawal design study for Lyrica (pregabalin) in patients with inadequately treated painful diabetic peripheral neuropathy (pDPN) did not meet its primary efficacy endpoint, change in endpoint mean pain score relative to baseline.

PURE Bioscience, Inc. (NASDAQ:PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that Intercon Chemical Company is showcasing the PURE Complete System in conjunction with its Clearly Better Solutions product line at this year’s National Restaurant Association Show, May 5-8 at McCormick Place in Chicago (booth number 1085).

SDIX (Nasdaq: SDIX)
- a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, expects to release its first quarter 2012 results at approximately 4 p.m. ET on Thursday, May 10, 2012.



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