|Ariad Able to Continue Its EU Iclusig Sales; Threshold Reports New Clinical Data on TH-302|
|By Staff and Wire Reports|
|Friday, 22 November 2013 20:16|
Shares of Ariad Pharmaceuticals (NASDAQ: ARIA) surged Friday, after the company revealed advisors to European Union regulators believe the company's Iclusig cancer drug should stay on the European market. Iclusig is used to treat two rare types of leukemia.
Iclusig is Ariad's only product and was approved by both the FDA and the European Medicines Agency in 2012.
On Oct. 31, however, the Food and Drug Adminstration asked the company to suspend marketing and sales of Iclusig. The watchdog group issued a warning to the company on Oct. 11 after discovering around 24 percent of patients using the drug had heart attacks, strokes and other serious vascular events.
Prior to that, on Oct. 9, shares of Ariad plunged 66 percent, after the company was forced to roll out a lower dosing schedule for patients. The roll out came after investigators discovered a rising rate of blood clots among patients taking the treatment. Shares declined a further 28 percent over the two next two days.
Shares lost an additional 40 percent on Oct. 18, after the company said it will shut down its pivotal EPIC 3 clinical study of Iclusig, before hitting multi-year lows of $2.15 in late October.
On Friday Oppenheimer released a company update report, urging investors to exercise caution.
“While this is a positive outcome for Ariad, we remain cautious as the EMA's in-depth investigation of Iclusig is still ongoing," noted David Ferreiro, a senior analyst and research director with the research firm, "and further changes to the label or a recall are still possible depending on the outcome of the investigation."
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD), announced early data from the Phase 1 portion of an investigator-sponsored Phase 1/2 trial of its investigational hypoxia-targeted drug TH-302 in combination with Avastin(R) (bevacizumab) in patients with recurrent glioblastoma following bevacizumab failure (Study 4003). No dose-limiting toxicity has been reported to date at doses of TH-302 up to 670 mg/m2 plus bevacizumab at 10 mg/m2 every two weeks. Preliminary data in 14 patients showed TH-302 in combination with bevacizumab was associated with a median time to progression of 2.8 months. One patient achieved a complete response and two patients achieved partial responses. The data will be presented this evening from 7 p.m. to 9 p.m. at the 4th Quadrennial World Federation of Neuro-Oncology (WFNO) meeting held in conjunction with the 18th annual 2013 Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), San Francisco, CA.
Chemotherapy with radiotherapy is standard care for newly diagnosed glioblastoma. Bevacizumab is approved in the U.S. for progressive disease following prior therapy. After disease progression on bevacizumab, patients may start a subsequent bevacizumab-containing regimen. These patients typically progress in 5 to 8 weeks.(1,2) Three-month progression-free survival is approximately 15%.
Adherex Technologies Inc. (TSX:AXH) (OTCQB:ADHXF), announced today that it has completed the previously-announced non-brokered private placement (the "Offering") of 4,000,000 units for gross proceeds of US$1,600,000.
Alcobra Ltd. (Nasdaq:ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Metadoxine extended-release), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, announced today the results from a preclinical abuse liability study that evaluated the potential reinforcing effects of Metadoxine (i.e. its ability to produce psychological dependence or craving) using a well-established self-administration procedure in methylphenidate-trained rats.
Cancer Genetics, Inc. (Nasdaq:CGIX) is jointly hosting an event today with the Mayo Clinic announcing the first projects to be pursued by their joint venture, which is set to develop targeted diagnostic panels that leverage next generation sequencing ("NGS").
iMedicor, Inc. (OTC Pink: VMCI), a Nevada corporation, formerly known as Vemics, Inc. (the "Company"), a builder of portal-based, virtual work and learning environments for the healthcare and related industries, announced the departure of Fred H. Zolla as Executive Chairman of the Board of Directors, effective as of the close of business on November 18, 2013.
Landec Corporation (Nasdaq:LNDC), a materials science company that develops and markets innovative and patented products for healthy living applications in food and biomedical markets, announced that it expects second quarter of fiscal 2014 net income to be approximately $0.13 per diluted share due to severe shortages of produce resulting in much higher than projected costs for raw materials in the Company's value-added vegetable business.
LifeVantage Corporation (Nasdaq:LFVN), a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically-validated products, introduced David Phelps as its first-ever Chief Sales Officer on Tuesday, and already Phelps is speaking out.
OmniComm Systems, Inc. (OTC:OMCM), one of the fastest growing companies in the Electronic Data Capture (EDC) marketplace, celebrated innovation and excellence at their annual Innovation Forum in Ft. Lauderdale last week.
Regenerative medicine company Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) announced that it was today awarded the 'Financing Deal of the Year' at the 9th Annual 2013 SCRIP Awards in London, adjudicated by an independent panel of 15 judges who acknowledged corporate accomplishments in the pharmaceutical industry.
Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that clinical trial results of a synthetic peptide vaccine for brain cancer, now being developed as SL-701, will be presented by investigators from the University of Pittsburgh at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) being held in conjunction with the 18th Annual Society for Neuro-Oncology (SNO) meeting in San Francisco, California on November 21-24, 2013. SL-701 is a subcutaneously-administered cancer vaccine comprised of multiple synthetic peptides corresponding to targets on tumor bulk and cancer stem cells (CSCs).
Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR® (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment.