Agios Pharma Reports Initiation of Phase 1/2 Clinical Trial of AG-221; Pluristem Advances its Second Major Cell Therapy Product Line Print
By Mary Davila   
Tuesday, 21 October 2014 18:35

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 21, 2014.

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, announced the initiation of a Phase 1/2 multicenter study of AG-221 in patients with advanced solid tumors, including gliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry an isocitrate dehydrogenase-2 (IDH2) mutation. The study will enroll patients who have recurred or progressed following standard therapy or have not responded to prior standard therapy. This is the second trial to be initiated in patients with cancer as part of AG-221's clinical development program, which includes the ongoing Phase 1 trial with four expansion cohorts in patients with hematologic malignancies.

Preclinical evidence shows that mutant IDH2 enzyme, the target of AG-221, produces 2-hydroxyglutarate (2HG), which blocks the normal maturation of progenitor cells. In solid tumor cells expressing the IDH2 mutation, AG-221 inhibited the production of 2HG, which has the potential to affect differentiation and cell proliferation in patients with solid tumors. In addition, AG-221 has demonstrated an acceptable safety profile and evidence of antitumor activity in the ongoing Phase I trial of AG-221 in patients with advanced hematologic malignancies that carry an IDH2 mutation.

"Evaluating AG-221 in patients with advanced solid tumors is an important next step in our efforts to understand the potential of this investigational medicine to treat a broad range of cancers with the IDH2 mutation," said Chris Bowden M.D., chief medical officer at Agios. "The safety, pharmacokinetics, clinical activity, and effect on the biomarker 2HG we have observed from the different dose levels studied in the Phase 1 trial for advanced hematologic malignancies give us insights into the potential to fight cancer in patients with advanced solid tumors. AG-221 will only be evaluated in prospectively defined patients whose cancers carry an IDH2 mutation, and who we believe have the greatest potential to benefit from treatment."

 


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Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR)
, a leading developer of placenta-based cell therapy products, announced it has completed development of its second major product line, and can now begin manufacturing the cells on a large-scale at its state-of-the art facility in order to meet demand for anticipated studies in a range of hematologic conditions.

This second cell product candidate, called PLX-RAD, was created using Pluristem’s proprietary three dimensional cell expansion technology platform. The Company’s first product, PLX-PAD, is already in clinical trials for the treatment of peripheral artery disease, muscle injury and pulmonary arterial hypertension.

Pluristem’s development plan for the PLX-RAD cells considers numerous potential clinical indications such as: 1) enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of  bone marrow deficiency, which can result from immune system disorders, genetic diseases, and treatment of leukemia and other blood cancers; 2) treatment of bone marrow deficiency in patients who have undergone chemotherapy; 3) treatment of acute radiation syndrome (ARS) in conjunction with the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

“We’ve just completed a two-year development cycle for our PLX-RAD cells, and have also developed new manufacturing equipment, methods and

know-how. We believe that our state-of-the-art technology platform can be used to create additional cell products from the placenta, tailored to potentially deliver targeted treatments for a variety of new indications,” stated Zami Aberman, Chairman and

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CEO of Pluristem.

“Our technology platform, robust manufacturing capabilities and

broad IP portfolio open the door for potential institutional and commercial partners, and we’re pleased with the level of interest we have received in our technology platform. Pluristem is in a unique position to be a leader in the cell therapy industry,” Aberman concluded.

Data from a study of PLX-RAD cells conducted at Hadassah Medical Center were published in the peer-reviewed journal, PLOS ONE.


 
Also Tuesday:


 
Agios Pharmaceuticals, Inc. (Nasdaq:AGIO)
, a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced the initiation of a Phase 1/2 multicenter study of AG-221 in patients with advanced solid tumors, including gliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry an isocitrate dehydrogenase-2 (IDH2) mutation.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based diagnostics, announced today that it has received a formal Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its genomic probe set used to detect biomarkers indicative of HPV-associated precancer and cancer of the cervix, anus, vulva, vagina, penis, oropharynx, and pharynx.

Cellular Dynamics International, Inc. (Nasdaq:ICEL)
today announced that Chief Executive Officer Bob Palay will present at the Cleveland Clinic's 2014 Medical Innovation Summit to be held October 27-29 in Cleveland.

ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced Phase I data with CCX507, a next-generation potent and specific inhibitor of the chemokine receptor known as CCR9.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced it will report third quarter financial results after the close of market on November 4, followed at 4:30 p.m. Eastern Time by a conference call and audio webcast at www.codexis.com.

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX)
announced today that it will release third quarter 2014 financial results after the market closes on Tuesday, November 4, 2014. 

EDAP TMS SA (Nasdaq:EDAP)
, the global leader in therapeutic ultrasound, today announced the sale of a Focal One system to Nantes-Atlantis urology clinic, the top-ranked private prostate cancer clinic in France, and the country's only private clinic exclusively dedicated to urology.

Intuitive Surgical, Inc. (Nasdaq:ISRG)
, the industry leader in robotic-assisted surgery, today announced financial results for the quarter ended September 30, 2014.

Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that it has released to market its innovative home oxygen concentrator called the Inogen At Home™.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
, announced today that it will release its third quarter 2014 financial results on October 28, 2014, after the market close.

LHC Group, Inc. (Nasdaq:LHCG)
, a national provider of home health, hospice and comprehensive post-acute healthcare services, today announced that a total of 124 LHC Group home health locations have been ranked among the nation's best in an independent rating of home health quality and performance.

Macrocure Ltd. (Nasdaq:MCUR)
, a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, will announce financial results for the third quarter ended September 30, 2014 after the close of the U.S. financial markets on Monday, November 3, 2014.

Materialise NV (Nasdaq:MTLS)
today announced the acquisition of UK-based OrthoView Holdings Limited, the world's leading provider of 2D digital pre-operative planning and templating solutions for orthopedic surgeons. Materialise acquired OrthoView for a cash payment of £8.47 million, and a possible additional earn out payment of up to £0.36 million.

MELA Sciences, Inc. (Nasdaq:MELA)
, developer of MelaFind®, a non-invasive software-driven image analysis device intended to provide a dermatologist with objective data of clinically irregular pigmented moles when they choose to obtain additional info to help them decide whether or not to biopsy (at the most curable and cost-effective stage), today announced that highly favorable results were obtained in a study using MelaFind to assess lesions in patients at risk for melanoma.

mCig®, Inc. (OTCQB:MCIG)
, a technology company that owns, manufactures, and distributes the mCig®, VitaCig®, and Vapolution products, is pleased to announce that the company's wholly owned subsidiary: VitaCig, Inc. has executed a historic distribution agreement awarding San Francisco based Omnicam and its Korean partner Kooleever Inc. with exclusive rights to distribute VitaCig® products in the Republic of Korea in territories covering a population of 50 million people.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that it will issue financial results for the fiscal first quarter 2015 following the close of market on Tuesday, November 4, 2014.

Nanosphere, Inc. (Nasdaq:NSPH)
, a company enhancing medicine through targeted molecular diagnostics, today announced that it has commenced an underwritten public offering of its common stock.

Novadaq® Technologies Inc. (Nasdaq:NVDQ) (TSX:NDQ)
, the leading developer and provider of clinically relevant fluorescence imaging solutions for use in surgical and diagnostic procedures, today announced that it has entered into an exclusive 5-year agreement with Mizuho Medical Corporation for distribution of the PINPOINT® Endoscopic Fluorescence Imaging System in Japan.

Otonomy, Inc. (Nasdaq:OTIC)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the appointment of Anthony J. Yost as chief commercial officer.

Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today financial results for the third quarter ended September 30, 2014.

Quotient Limited (Nasdaq:QTNT)
, a commercial-stage diagnostics company, today announced that financial results for its fiscal second quarter ending September 30, 2014 will be released after market close on Monday, November 3rd, 2014.

Radius Health (Nasdaq:RDUS)
announced today that it will release its third quarter 2014 financial results on Tuesday, November 11, 2014.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today reported results from a large, controlled, long-term safety study comparing Androxal® to a placebo. In this study of Androxal®, ZA-303, no new safety signals were identified, including no evidence of negative effects on bone mineral density.

Sanomedics International Holdings, Inc. (OTCQB:SIMH)
, a medical technology and services holding company that focuses on providing game changing products, services and ideas, is pleased to announce that, through an acceleration of previously disclosed rights by Redwood Management, LLC, the Company has satisfied all outstanding debt obligations owned to TCA Global Credit Master Fund LP and all litigation with TCA has been dismissed.

Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP)
, a global biopharmaceutical company, and Takeda Pharmaceutical Company Limited (Takeda) today announced that on October 17, 2014, they entered into a global license, development, commercialization and supply agreement for AMITIZA® (lubiprostone).

Therapix Bio (TASE:TRPX) (OTCQB:THXBY)
announces that it recently entered into a Term Sheet for the acquisition of Dekel Pharmaceuticals Ltd., a privately-held company engaged in the research and development of drug therapies based on synthetic cannabinoid substances.

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP)
announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to study TNX-201 for the treatment of episodic tension-type headache.

Vascular Solutions, Inc. (Nasdaq:VASC)
today reported financial results for the third quarter ended September 30, 2014.




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