PARIS–(EON: Enhanced Online News)–Regulatory News:

“given this substantial advantage in survival coupled with lower toxicity of masitinib as compared with Sutent®, we believe that masitinib is an important step forward in the treatment of GIST.”

AB Science SA (Paris:AB) (NYSE Euronext – FR0010557264 – AB) today announced encouraging results from a phase 2 study with its investigational drug, masitinib, in Gleevec®-resistant gastrointestinal stromal tumors (GIST). Masitinib significantly improved overall survival in patients with Gleevec®-resistant gastrointestinal stromal tumors (GIST) as compared to Sutent® (sunitinib) from Pfizer, a drug approved for second-line treatment of GIST, currently the standard of care for these patients. In this study, 44 patients with inoperable, locally advanced or metastatic GIST and showing disease progression while treated with Gleevec® (imatinib) (400 to 800 mg/day) received either masitinib (23 patients) at 12 mg/kg/day or Sutent® (21 patients) until progression. After a median follow-up of 14 months, median overall survival was not reached for masitinib versus 15 months for Sutent® (p=0.022 HR:3.2). After 18 months, 79% of patients treated with masitinib were still alive, versus 20% for patients treated with Sutent®. After 2 years, 53% of patients treated with masitinib were still alive, versus 0% for the patients treated with Sutent®.

The study also demonstrated that masitinib was significantly better tolerated than Sutent®. The safety profile of masitinib was better than that of sunitinib, with a significantly longer Safety Event Free Survival (p=0.002), and a lower occurrence of severe adverse events. In masitinib treated patients, nausea, diarrhea and asthenia were the most common related adverse events. full data has been submitted for publication to the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting.

Axel Le Cesne, MD (Institut Gustave Roussy, France), the principal investigator of this study declared: “Given this substantial advantage in survival coupled with lower toxicity of masitinib as compared with Sutent®, we believe that masitinib is an important step forward in the treatment of GIST.”

Olivier Hermine, MD, PhD, President of the Scientific Committee of AB Science commented: “Masitinib differs from Sutent® by its selectivity profile. unlike Sutent®, which targets a broad spectrum of protein kinases, masitinib is very selective, which brings better tolerability. Furthermore, in addition to killing cells that make up the tumors, masitinib has a complementary mode of action that may also kill cancer stem cells and trigger an immune response, which may further enhance its efficacy. these promising results in second line treatment of GIST, which correlate with the encouraging results previously reported in the first line treatment of GIST, tend to confirm that masitinib has an original mechanism of action that may translate into improved survival.”

About GIST

Gastrointential stromal tumor (GIST) is a sarcoma, which is a type of cancer that develops in the cells of the body’s connective or supportive tissues. GIST arises within the gastrointestinal tract. it is estimated that approximately 5,000 to 6,000 new patients are diagnosed with GIST each year in the United States. In 2010, the global GIST therapeutics market was valued at $920 million, and forecast to grow at a rate of 2% annually.

Masitinib received orphan drug designation in the treatment of GIST from both the FDA and EMA.

About masitinib

Masitinib is an investigational orally administered tyrosine kinase inhibitor that targets mast cells, important cells for immunity, as well as a limited number of kinases that play key roles in various cancers. Owing to its novel mechanism of action, masitinib can be developed in a large number of conditions in oncology, inflammatory diseases and certain diseases of the central nervous system. Through its activity of inhibiting certain kinases that are essential in some oncogenic processes, masitinib may have an effect on tumor regression, alone or in combination with chemotherapy. Through its activity on the mast cell and certain kinases essential to the activation of the inflammatory cells and fibrosing tissue remodeling, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases.

About AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of novel targeted therapies for patients with cancer and other significant unmet medical needs including inflammatory and central nervous system diseases. AB Science has developed a proprietary portfolio of protein kinase inhibitors (PKIs), a new class of targeted molecules whose action is to modify signaling pathways within cells. AB Science’s lead product, masitinib, has already been registered in veterinary medicine in Europe and the US, and is currently in 9 phase 3 human studies, including 8 studies on-going in pancreatic cancer, GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, mastocytosis, severe persistent asthma, rheumatoid arthritis, and progressive multiple sclerosis. The Company is headquartered in Paris, France, and is listed on Euronext Paris (Ticker: AB).

Further information is available on AB Science’s website: ab-science.com

This document contains prospective information. no guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present.

02.07.2011– February 7, 2011 (Cincinnati, Ohio) — Results of two Phase 1 clinical trials of S-equol (AUS-131) were published in the February issue of Menopause: The Journal of the North American Menopause Society. this first-in-class, nonsteroidal, nonhormonal estrogen receptor ? (ER?) agonist offers a potentially safer alternative to estrogen for the treatment of menopausal symptoms. As part of a drug development program, these studies were the first to investigate AUS-131 in humans. Results demonstrated a favorable safety and pharmacokinetic profile for AUS-131, and have allowed the company to proceed to Phase 2 clinical trials, which will be completed in Q3 2011. these studies evaluated the pharmacokinetics and tolerability of single and multiple oral doses of AUS-131 in healthy volunteers. these studies also established the doses for proof-of-concept Phase 2 studies investigating AUS-131 as a treatment for postmenopausal women with vasomotor symptoms (VMS), commonly referred to as hot flashes. Results also support Ausio’s development of AUS-131 as a treatment option to inhibit prostate cell growth in men with benign prostatic hyperplasia (BPH). The full paper is available at: journals.lww.com/menopausejournal/Abstract/2011/02000/Single_dose_and_steady_statepharmacokinetic.15.aspx “One of the compelling reasons for developing S-equol as a pharmaceutical product is that women are reluctant to take estrogens for their menopausal symptoms” said Richard Jackson, PhD, Ausio Pharmaceuticals, LLC, President and CEO, and the study’s lead author. “Based on the Phase 1 studies, AUS-131 offers an oral medication that safely delivers therapeutic levels of S-equol, which may benefit patients with a variety of diseases and conditions.” History of Treatment of Menopausal Symptoms and Significance of S-Equol whereas hormone therapy (HT) has been the therapy of choice for the management of menopausal symptoms in women, the Women’s Health Initiative has shown that HT has been associated with increased risk of invasive breast cancer, coronary heart disease, stroke, and deep vein thrombosis. this increased risk is associated with the abundance and prominent role of the estrogen receptor ? (ER?) in the breast, uterus, and endothelium in the cardiovascular system. Alternative treatments for VMS have included serotonin, norepinephrine, mixed reuptake inhibitors, and botanicals such as soy products and black cohosh, but these treatments have both efficacy and safety issues. beyond botanicals, purified, nonsteroidal isoflavones found in soy—genistein, daidzein, and glycitien—have been studied for the treatment of chronic diseases in the aging population, including, among others, VMS in postmenopausal women, with limited success. Daidzein is further biotransformed to the isoflavan S-equol by the intestinal bacteria flora of certain individuals, particularly Asians. Published reports show that patients who demonstrate the health benefits of soy are those who are equol producers. Cincinnati-based Ausio Pharmaceuticals, LLC has developed a patented chemical process for the synthesis of S-equol that allows for large-scale production of pure GMP-quality S-equol to conduct clinical trials. About the Studies two randomized, double-blind, placebo-controlled clinical trials were performed in healthy volunteers: a single-rising dose study in 61 participants and a 14-day repeat-dose study in 40 participants. Safety, tolerability, and pharmacokinetics of AUS-131 were assessed in both men and women. AUS-131 was well-tolerated by all participants with no significant drug-related adverse events at doses several-fold higher than the expected therapeutic range. Food decreased maximal plasma concentration but did not significantly affect overall exposure to the drug. AUS-131 was readily absorbed with a steady-state level of S-equol achieved after the first day of twice-daily dosing. The pharmacokinetics of the drug were linear with dose and showed that the drug was readily cleared from the body. Subjects receiving the lower doses of AUS-131 achieved plasma levels of S-equol equivalent to those that researchers have associated with the health benefits of ingestion of soy. these studies in healthy participants also provided the first report of plasma and urine levels of unconjugated S-equol after oral dosing using a recently published highly sensitive method. Results from Phase 1 studies provided dosing information for the ongoing international, multicenter Phase 2a efficacy trials in patients with VMS and BPH. About AUS-131 AUS-131 is a first-in-class, nonsteroidal, nonhormonal, selective ER? agonist that has the potential to provide the therapeutic benefits that researchers have attributed to soy ingestion. Importantly, results to date show that the compound has an excellent safety profile. AUS-131 is pure, synthetic S-equol, which is a soy isoflavone that is naturally produced in a small percent of individuals in the US after ingestion of soy. this molecule is being evaluated for a wide range of indications, including menopausal symptoms, BPH, osteoporosis, and topical applications. About Vasomotor Symptoms In the US, there are more than 40 million postmenopausal women. More than 70% of these women experience hot flashes. The major products available to treat these symptoms are estrogens, which have current US sales of $1.8 billion, despite the risks associated with their use. The results of the Women’s Health Initiative study showing increased risk of breast cancer, cardiovascular events, stroke, and venous thrombosis with long-term estrogen-progestin therapy have dramatically decreased the use of estrogen therapy and increased the market opportunity for new VMS therapy with an ER? agonist, such as the S-equol product, AUS-131. About Ausio Pharmaceuticals Ausio Pharmaceuticals, LLC, is a private biotechnology development company focused on the advancement of safe and effective medicines for the aging population. Ausio was founded in 2006 by Richard Jackson, PhD based on technologies licensed from the Australian Health and Nutrition Association Ltd, NSW, Australia, and Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio. The company has garnered a strong patent position for its lead compound, AUS 131. it has rapidly developed AUS-131 by working with excellent service providers. Ausio’s strategic goal is to collaborate with international pharmaceutical partners for AUS-131 in the US and other markets worldwide. for further information on Ausio, please visit the company’s website at ausiopharma.com. CONTACT: Iris Shaffer (708) 799-6284

We want to talk about several companies that are gaining some recent momentum. They all have catalysts that investors should be watching for.

With potential catalysts ahead that could easily transform their companies, money flow in these stocks should be relatively high. we feel that these all have potential for success over the coming months. these stocks were alerted to subscribers on Friday(11/19). (Relevant links for each stock can be found at the bottom.)Amarin Corporation (NASDAQ: AMRN) 

Cyclacel Pharmaceuticals Inc. (NASDAQ: CYCC) has had some interesting movement recently. in their 3rd quarter update, investors learned that they would present Phase 2 1-year survival data of sapacitabine in patients with MDS at American Society of Hematology(ASH) in December 2010(the 4th, to be specific). CYCC hopes that sapacitabine will eventually be used as a 2nd-line treatment in MDS. There needs to be >50% survival rate at 1-year for sapacitabine to be meaningful in this disorder. at ASCO 2010, they reported interim data on the overall response rate with 24 ? 35%. in mid-October they announced private placement to sell approximately $15.2M of its units to several institutional investors. we are still waiting on top line results from the APPRAISE NSCLC Phase 2b trial of seliciclib and interim Phase 2 data of sapacitabine in patients with NSCLC.

Inhibitex, Inc. (NASDAQ: INHX) shares were up 10+% today. Next month they are expected to announce results from their Phase 2 program in Shingles with FV-100. Investors should take note that this Phase 2 is evaluating FV-100 against an active control arm in Glaxo’s Valtrex. They also recently initiated a Phase 1b trial in Chronic Hepatitis C(HCV) and results should be expected sometime in early 2011. Both of these programs have substantial value if proven effective. INHX had around $25M in cash/cash eqiv. as of September 30th. Management has had some interest in both of these programs and potential partners could emerge sometime in 2011. Today, they filed a $20M shelf; they stated that they have no current plans to sell shares now, but may do so after top-line results from their trials.

Neoprobe Corporation (OTC: NEOP) is another company to keep your eyes on. after the recent mention by Uri Landesman, President of Platinum Partners, about Neoprobe being an interesting acquisition by Covidien or Cardinal Health sometime in 2011, assuming Lymphoseek Phase 3 trials are successful. They recently raised $6M in cash. Notably, insiders have been buying very recently. On 11/15, insiders collectively purchased 70K shares(about $120K) on the open market. last week they gave several Lymphoseek presentations at the International Sentinel Node Society (ISNS) Bi-Annual Meeting 2010.

“Lymphoseek presentations at ISNS 2010 signal an important step in the international clinical community’s interest in the technology’s potential to improve lymph node mapping and patient treatment and care, and the growing importance of accurate intra-operative identification of sentinel lymph nodes in surgical oncology,” said Dr. Frederick O. Cope, Senior Vice President of Pharmaceutical Research and Clinical Development of Neoprobe. Neoprobe has plans to investigate Lymphoseek’s clinical potential to help improve diagnosis in melanoma, breast, head and neck cancer and other solid tumor cancers.

Repligen Corporation (NASDAQ: RGEN) is another attractive biotech that has revenues, cash and data coming in 2011. RGEN is the world’s biggest supplier of Protein A, necessary for the production of monoclonal antibodies, which are important therapies for cancer, autoimmune diseases and osteoporosis. in terms of catalysts, they have 2 big Q1 2011 clinical catalysts: Phase 3 data for RG1068(pancreatic imaging agent) and Phase 2b data for their bipolar drug(RG2417). Phase 2a results demonstrated a statistically significant reduction in the symptoms of depression in patients receiving RG2417 (vs. placebo) on the MADRS and on the CGI-BP-C over the 6-week course of the study. RG2417 was safe and well tolerated. They have a great share structure(30M O/S), $55M in cash/cash equivalents and significant insider/institutional ownership.

Disclosure: Long AMRN, CYCC, INHX

AMRN appointment – aol.it/aqBLJI

CYCC 3Q 2010 results – bit.ly/akkdfQ

NEOP CNBC video – bit.ly/aKdHpcNEOP Insider buys – aol.it/97diHr

RGEN completes patient enrollment in Phase 2b Clinical Trial Of RG2417 for Bipolar Depression – bit.ly/ayr1V5RGEN institutional ownership – aol.it/ddgWHh

INHX Completes Enrollment in Phase II Clinical Trial of FV-100 – bit.ly/aYh3HpINHX Initiates Phase 1b Trial of INX-189 in Patients with Chronic Hepatitis C – bit.ly/9jKbak

Read the full report: biomedreports.com/2010112460547/5-small-cap-biotechs-that-investors-should-be-watching.html#ixzz16n3yUcn4