Biotech R&D and Clinical Trials Lead To Potential Revenue Growth - Company's Data of Phase l & Phase ll For HCC Patients Highly Suggestive of Positive Clinical Activity

CORAL SPRINGS, Florida, June 25, 2014 /PRNewswire/ --

Biotech sector sees progress as companies develop advanced cancer therapeutics resulting in significant clinical data; company reaches agreement to develop drug aiding cancer treatment:  GenSpera, Inc. (OTC: GNSZ), Seattle Genetics Inc. (NASDAQ: SGEN), (Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), OXiGENE, Inc. (NASDAQ: OXGN) and MerriMack Pharmaceuticals, Inc. (NASDAQ: MACK)

GenSpera, Inc. (OTCQB: GNSZ), a leader in developing prodrug therapeutics for the treatment of cancer, releases the 2014 BIO International corporate presentation. Chairman and CEO, Craig Dionne, PhD, presented the company overview and clinical trial updates for G-202 at the 2014 BIO International Convention yesterday in San Diego, CA.

Dr. Dionne presented interim results from the Phase Ib and ongoing Phase II study in hepatocellular (HCC) patients who had previously progressed on, or who were intolerant of, sorafenib. Historically, this patient population has a median time to progression of only two months when they enter subsequent clinical trials. Impressively, 80% of patients treated with G-202 had stable disease (no tumor growth) at two months and 50% of patients exhibited stable disease at 4 months on study.

To read the full GNSZ press release, please click here: http://www.fnmprofiles.com/profiles-gnsz.html

Commenting on the Phase I and II data of G-202 in HCC Patients, Dr. Dionne stated, "Our lead candidate, G-202, is demonstrating better than expected clinical results and safety profile. These data are strongly encouraging and highly suggestive of clinical activity in this very challenging patient population. Relative to other drugs currently in advanced trials in HCC patients, G-202 appears to exhibit a better tolerated side effect profile and a larger subset of patients who experience disease stabilization of at least six months. Remarkably, one patient remains on treatment 22 months after initiation of treatment and another patient experienced complete remission of bone pain due to a metastatic lesion to the spinal column. As a result of these data, we  are designing a randomized study as the next step toward United States Food and Drug Administration approval of G-202."  

Seattle Genetics Inc. (NASDAQ: SGEN) recently presented interim phase 1 clinical data from SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies. "We continue to make strong progress advancing our proprietary pipeline programs, with SGN-CD19A representing one of five ADCs in clinical development. SGN-CD19A targets a promising cancer marker expressed in a variety of hematologic malignancies," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "These interim phase 1 data in aggressive non-Hodgkin lymphomas presented at ASCO, along with previous phase 1 data in acute lymphoblastic leukemia, demonstrate that SGN-CD19A has encouraging antitumor activity with multiple complete remissions in a patient population with significant unmet needs. The safety profile of SGN-CD19A is generally manageable with a notable absence of significant neuropathy or bone marrow suppression, which may enable future clinical trials with novel combination regimens. We look forward to final results from this ongoing phase 1 clinical trial to inform future SGN-CD19A program development plans."

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV₁) in people ages 12 and older with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. All four 24-week combination treatment arms in the studies, known as TRAFFIC and TRANSPORT, met their primary endpoint of mean absolute improvement in ppFEV₁ from baseline compared to placebo at the end of treatment. Mean absolute improvements in ppFEV₁ of between 2.6 and 4.0 percentage points from baseline compared to placebo were observed across the studies (p≤0.0004), with mean relative improvements of 4.3 percent to 6.7 percent (p≤0.0007).

OXiGENE, Inc. (NASDAQ: OXGN)  a clinical-stage biopharmaceutical company, develops therapeutics primarily to treat cancer. The company focuses on developing vascular disrupting agents (VDAs) that disrupt abnormal blood vessels associated with solid tumor progression. Its principal clinical product candidate is ZYBRESTAT, which is in development as a treatment for solid tumors. The company is also developing OXi4503, a second-generation product candidate for acute myeloid leukemia. On Tuesday, OXGN closed down .38% on over 1.2 million shares traded.

MerriMack Pharmaceuticals, Inc. (NASDAQ: MACK) recently announced that it has reached an agreement with Sanofi to regain worldwide rights to develop and commercialize MM-121, a monoclonal antibody designed to block ErbB3 (HER3) activation in patients with heregulin-positive tumors and improve response to standard of care treatments. In partnership with Sanofi, Merrimack completed an extensive Phase 2 program for MM-121 which was designed to assess the role of ErbB3 in a number of cancer indications in both the metastatic and neoadjuvant settings. In advanced settings of ovarian cancer, ER/PR+ HER2 negative breast cancer and non-small cell lung cancer, Merrimack was able to identify that heregulin, the principal ligand that binds to and activates the ErbB3 receptor, is associated with poor response to standard of care therapy and that adding MM-121 may restore sensitivity in these most at-risk patients.

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