Biotech Advancements in Innovative Cancer Therapy Reveal Developing Systemic Treatment Options - Company Receives Recommendation from World Health Organization for Lead Drug Candidate

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Sep 04, 2014, 08:15 ET

CORAL SPRINGS, Florida, September 4, 2014 /PRNewswire/ --

Biotech companies seeking to make progress with Hepatocellular Carcinoma (HCC) therapies and other cancer therapeutics: GenSpera Inc. (OTC: GNSZ), Roche Holding AG (OTC: RHHBY), Eli Lilly and Company (NYSE: LLY), Amgen Inc. (NASDAQ: AMGN), Johnson and Johnson (NYSE: JNJ) and Infinity Pharmaceuticals Inc. (NASDAQ: INFI)

GenSpera, Inc. (OTCQB: GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, today announced that the World Health Organization's (WHO) International Nonproprietary Name (INN) group has recommended the generic name "mipsagargin" (mip sa gar' jin) for its lead drug candidate, also known as G-202, currently in Phase II clinical trials for hepatocellular carcinoma (liver cancer) and glioblastoma (brain cancer). Mipsagargin was also recommended by the United States Adopted Names Council (USAN) of the American Medical Association.

Craig Dionne, PhD, GenSpera's CEO, spoke to the significance of this issuance, "We are pleased that the INN division of WHO and the USAN Council recognized the unique nature of mipsagargin by affording it the new suffix, or pre-stem, of "gargin." The WHO issues approximately 160 name recommendations per year with only 1-2% having new suffixes. New suffixes are generally given to compounds with a unique mechanism of action or structure and serve to define such compound as the first in a possible new class of pharmacological agents. We believe mipsagargin's name recommendation is the result of G-202's novel nature and our innovative approaches to cancer therapy."

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GenSpera recently released interim results from the Phase Ib and ongoing Phase II study in hepatocellular carcinoma (HCC) patients who had previously progressed on, or who were intolerant of sorafenib. Data showed 80% of patients treated with mipsagargin had stable disease (no tumor growth) at two months and 50% of patients exhibited stable disease at four months on study. In addition, imaging analysis demonstrated an impressive blockade of tumor blood flow in the single patient evaluated by this method to date.

Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world in terms of incidence, accounting for approximately 630 thousand new cases per year; in addition, HCC is the third most common cause of cancer death. Worldwide, the greatest risk factors for HCC are the infections caused by hepatitis B and C viruses, which increase the risk of developing the disease by about 20 times. The standard treatment in the early stages of the disease, such as surgical resection, local ablation and liver transplantation, are able to cure a proportion of patients, but most cases of HCC present in advanced stages, precluding the use of such treatments with curative intent. In these advanced stages, systemic treatments are commonly used. Unfortunately, chemotherapy with conventional cytotoxic agents is ineffective and does not seem to modify the natural history of disease. Treatment options for patients with advanced HCC are extremely limited, but the identification of signaling pathways, and the recognition of the role of these pathways in the pathogenesis of the disease resulted in the development of drugs directed at specific therapeutic targets

Roche Holding AG (OTCQX: RHHBY) Seragon Pharmaceuticals Inc., a leader in developing drugs for hormone dependent cancers, recently announced the closing of its acquisition by Genentech, a member of the Roche Group. Deal terms included $725 million in cash up front along with $1.0 billion in contingent development milestone payments for total transaction value up to $1.725 billion. The acquisition includes Seragon's entire selective estrogen receptor degrader (SERD) program, including its most advanced compound, ARN-810, a next generation SERD that is currently being evaluated in a Phase I trial in postmenopausal women with locally advanced or metastatic estrogen receptor positive (ER+) breast cancer.

Eli Lilly and Company (NYSE: LLY) will participate in the Morgan Stanley 2014 Global Healthcare Conference at the Grand Hyatt in New York, NY, on Monday, September 8, 2014. Derica Rice, Lilly's Executive Vice President, Global Services and Chief Financial Officer, will participate in a fireside chat at 12:50 p.m. EDT. A live audio webcast will be available on the Webcasts & Presentations section of Lilly's Investor website at http://investor.lilly.com/events.cfm. Subsequently, a replay of the fireside chat with Mr. Rice will be available on this same website for approximately 180 days.

Amgen Inc. (NASDAQ: AMGN) recently announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumor immune response. If approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies. The MAA for talimogene laherparepvec contains data from more than 400 patients and is based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of talimogene laherparepvec in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Johnson and Johnson (NYSE: JNJ) will participate in the 2014 Morgan Stanley Health Care Conference on Wednesday, Sept. 10, at the Grand Hyatt New York. Dominic Caruso, Vice President, Finance & Chief Financial Officer will represent the Company in a session scheduled at 9:45 a.m. (Eastern Time). This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com. A webcast and podcast replay will be available approximately two hours after the live webcast.

Infinity Pharmaceuticals Inc. (NASDAQ: INFI) and AbbVie Inc. (NYSE: ABBV) recently announced that they have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of patients with cancer. Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMO^TM, a Phase 2 study in patients with iNHL, and DUO^TM, a Phase 3 study in patients with CLL. Under the terms of the agreement, Infinity will receive an upfront payment of $275 million and is eligible to receive up to $530 million in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405 million for the achievement of milestones through the first commercial sale of duvelisib.

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