Immunomedics Announces First Results of Labetuzumab-SN-38; ARIAD Announced the Presentation of Preclinical Data on Ponatinib Print E-mail
By Staff and Wire Reports   
Tuesday, 09 April 2013 19:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 9, 2013.

Immunomedics, Inc. (Nasdaq: IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that its proprietary antibody-drug conjugate (ADC), labetuzumab-SN-38, appears to be safe and reasonably well tolerated within a clinically effective dosage range in patients with advanced colorectal cancer. Results from this Phase I study were presented by Dr. Neil H. Segal from the Memorial Sloan Kettering Cancer Center, New York, NY.

Labetuzumab-SN-38 is one of three agents from the Company's robust ADC program that are in clinical development. Labetuzumab is a slowly-internalizing antibody that recognizes the carcinoembryonic antigen (CEA; CEACAM5 or CD66e), which is expressed in many solid cancers, including more than 80% of colorectal cancer. In prior clinical trials, the antibody was shown to be safe when administered unconjugated or bound to the radioisotope, iodine-131, for radioimmunotherapy.

SN-38 is the active metabolite of irinotecan, which is a standard therapy for patients with metastatic colorectal cancer, but has major gastrointestinal and hematologic toxicity. By targeting SN-38 directly to CEA-expressing tumors, delivery of SN-38 may be increased while mitigating systemic toxicity. Preclinical studies have shown that the antibody-drug linkage was susceptible to cleavage in serum, with 50% of SN-38 released in ~1.0 day, leading to a locally enhanced concentration within the tumor site. In animal models of human colorectal cancer, the ADC exhibited high anti-tumor activity.

The goal of this single-arm, dose-escalation study was to determine the maximum-tolerated dose of labetuzumab-SN-38 in patients with metastatic colorectal cancer. Patients who had previously been treated with at least one prior irinotecan-containing regimen were enrolled to receive 2 doses of the ADC separated by 14 days. In the absence of unacceptable toxicity or disease progression, treatment continues for at least 24 weeks for a total of 12 cycles. Treatment may continue past 24 weeks if the patient reports a partial response or stable disease, with no unacceptable toxicity.

At the time of reporting, 11 patients with a median of 5 prior therapies have been treated at the 2, 4, 8, and 16 mg/kg dose levels. The average number of doses given was 3.9, with 6 of 11 patients receiving 3 or more doses. Five patients received 2 or more doses of 16 mg/kg, of which 1 has currently received 18 doses and has a continuing partial response after 8 doses.

One dose-limiting toxicity was observed at 16 mg/kg. Otherwise, the ADC was well tolerated. No human anti-humanized antibodies have been detected to date. Analysis of serum samples showed the intact conjugate clears more quickly than the antibody, consistent with SN-38 being gradually released from the ADC.


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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
announced the presentation of preclinical data on ponatinib (Iclusig™) at the American Association for Cancer Research (AACR) Annual Meeting 2013, in Washington. The study, “Ponatinib, a pan-BCR-ABL inhibitor, potently inhibits key activating and drug-resistant KIT mutants found in GIST,” shows that ponatinib inhibits activated and mutated forms of KIT, a clinically proven oncogenic driver found in approximately 80 percent of patients with gastrointestinal stromal tumors (GIST).

According to the American Cancer Society, approximately 4,000 to 5,000 people develop GIST each year in the United States. Approved agents for the treatment of patients with GIST include imatinib for newly-diagnosed patients, sunitinib for patients in whom imatinib has failed, and regorafenib for patients who have failed imatinib and sunitinib. Patients can develop resistance to any of these therapies by acquiring secondary KIT mutations. ARIAD plans to begin a Phase 2 trial of Iclusig in patients with GIST in the second quarter of 2013.

“ARIAD's development program for Iclusig focuses on its continued evaluation in patients with CML and exploration of its activity against other clinically validated targets. For the first time we were able to solve the x-ray crystal structure of ponatinib bound to KIT, rationalizing its activity in advance of the Phase 2 trial,” said Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. “These data provide important support for the use of Iclusig in patients with GIST who have become resistant to prior tyrosine kinase inhibitor therapy.”

The research conducted by ARIAD scientists used a broad panel of cell lines harboring mutant forms of KIT. Ponatinib showed potent activity against activated forms of KIT and against a range of secondary mutations that confer resistance to imatinib and/or sunitinib. These include mutations at the T670I gatekeeper residue and mutations in the activation loop (A-loop), common mutations found in patients who have failed currently available therapies.


Also Tuesday:


Affymetrix, Inc. (Nasdaq: AFFX)
today reported that based on preliminary financial data, the Company expects total revenue of approximately $78 million for the first quarter of 2013, including revenue of approximately $19 million from eBioscience.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced the presentation of preclinical data on ponatinib (Iclusig™) at the American Association for Cancer Research (AACR) Annual Meeting 2013, in Washington.

Arrhythmia Research Technology Inc. (NYSE MKT: HRT)
announces today that it has appointed Salvatore Emma, Jr. to serve as its President and Chief Executive Officer.

BioRestorative Therapies, Inc. (OTCBB: BRTX)
, a life sciences company focused on adult stem cell based cellular therapies for various personal medical applications, announced today that Wayne Marasco, M.D., Ph.D., Chairman of BRT's Scientific Advisory Board, will be speaking at the Second International Vatican Adult Stem Cell Conference: Regenerative Medicine -- A Fundamental Shift in Science and Culture.

CryoLife, Inc. (NYSE: CRY)
, a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that 2013 first quarter financial results will be released on Tuesday, April 30, 2013.

Easton Pharmaceuticals (OTC: EAPH)
, a specialty pharmaceutical company that designs, develops, and markets a premium array of topically-delivered therapeutic healthcare products announces corporate changes to its management and business product strategy.

GE Healthcare (NYSE: GE)
and iBio, Inc. (NYSE MKT: IBIO), today announced GE Healthcare has signed a contract to design a new plant-based multipurpose manufacturing facility for Bio-Manguinhos/Fiocruz in Brazil.

Inova Translational Medicine Institute, a not-for-profit research initiative bringing personalized medicine to the public, has chosen a joint solution by Medidata Solutions (NASDAQ: MDSO) and Digital Infuzion to support a unique observational study involving the correlation between a child’s genetic profile, their development and their long-term health.

LabStyle Innovations Corp. (OTCQB: DRIO)
, developer of the Dario™ smartphone-based diabetes management system, announces that its common stock is now trading on the OTC Market’s OTCQB marketplace and the OTC Bulletin Board under the ticker symbol DRIO.

Manhattan Scientifics (MHTX: OTCQB)
announced today that it has received the initial $1 million of a $2.5 million commitment to build the first generation of its advanced cancer detection devices.

Medicago Inc. (TSX: MDG); (OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs) and, IDRI (Infectious Disease Research Institute), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, today announced that they will be presenting positive interim Phase I clinical results for their H5N1 Avian Influenza VLP vaccine candidate "H5N1 vaccine" at the World Vaccine Congress.

Medtronic, Inc. (NYSE:MDT)
today announced market release of the CardioGuide™ Implant System, a novel real-time navigation system for cardiac resynchronization therapy pacemakers and defibrillators (CRT-P and CRT-D), in the United States and Canada.

Nordion Inc. (TSX: NDN) (NYSE: NDZ)
, a leading provider of products and services for the prevention, diagnosis and treatment of disease, will host two upcoming educational and scientific meetings to support the growth and expansion of TheraSphere® treatment in Europe. On April 11 – 12, Nordion will host its 3rd European TheraSphere User Group Meeting in Vienna, Austria and on April 18, Nordion will offer a Satellite Symposium at the 3rd Interdisciplinary Treatment of Liver Tumors (ITLT) Meeting in Essen, Germany.

Shire plc (LSE: SHP, NASDAQ: SHPG)
today launched a Rare Disease Impact Report, which uncovers the health, psycho-social, and economic impact of rare diseases on patient and medical communities in the United States (US) and United Kingdom (UK).

Sigma-Aldrich Corporation (NASDAQ: SIAL)
announced today that Sigma Life Science, its innovative biological products and services business, has signed an agreement with the Culture Collections of Public Health England, curators for the European Collection of Cell Cultures (ECACC®).

Sionix Corporation (OTCQB: SINX)
announced today the appointment of Dr. Henry W. Sullivan as its Chief Executive Officer and Chairman of the Sionix Board of Directors.

TelVue® Corporation (PINKSHEETS: TEVE)
-- the innovation leader in Television and Internet Broadcasting for cable operators, media companies and communities -- today launched the newest version of its award-winning HyperCaster IP broadcast server -- now with integrated multi-format decoding for baseband outputs and on-air graphics features.



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