Lipocine Submits New Drug Application to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021

SALT LAKE CITY, Aug. 31, 2015  -- Lipocine Inc. (LPCN), a specialty pharmaceutical company, today announced that it has submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone ("hypogonadism").

"Filing of the NDA for LPCN 1021 is a significant achievement for Lipocine and a major milestone toward bringing this potential testosterone replacement therapy option to patients. LPCN 1021 has the potential both to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. "We look forward to working closely with the FDA during the review process."

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Vital Therapies Announces Additional Data From VTI-208 Presented at Rostock Conference

SAN DIEGO, Aug. 31, 2015  -- Vital Therapies, Inc. (VTL), a biotherapeutic company developing ELAD(R), a cell-based therapy targeting the treatment of liver failure, today announced that additional data from its VTI-208 clinical trial were presented by two principal investigators of the study at the 16th International Symposium on Albumin Dialysis in Liver Disease on Saturday, August 29, 2015 in Rostock-Warnemunde, Germany. The conference's focus this year is: "Artificial and Bio-artificial Liver Support-Mechanisms of Action and Clinical Effects." Topline data from the VTI-208 clinical trial, which failed to reach its primary or secondary endpoints, was disclosed on August 21, 2015.

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Ceapro Inc. Reports Second Quarter 2015 Financial and Operations Results

EDMONTON, ALBERTA- - Ceapro Inc. (TSX VENTURE:CZO) ("Ceapro" or the "Company"), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today its financial results for the three-month and six-month periods ended June 30, 2015 and provided an overview of recent operational highlights.

Financial Highlights for the Second Quarter of 2015

  • Total sales of $2,439,000 in 2Q 2015 vs. $2,432,000 in 2Q 2014
  • Income from operations of $843,000 in 2Q 2015 vs. $727,000 in 2Q 2014
  • Gross margin of $1,749,000 in 2Q 2015 vs. $1,444,000 in 2Q 2014
  • Net profit of $658,000 in 2Q 2015 vs. $630,000 in 2Q 2014
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Oncolytics Biotech® Inc. Announces Completion of Enrollment in Randomized Phase II Non-Small Cell Lung Cancer Study

CALGARY, Aug. 26, 2015  Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that enrollment has been completed in a randomized Phase II study of REOLYSIN® in patients with previously treated advanced or metastatic non-small cell lung cancer ("NSCLC") (IND 211). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen's University in Kingston, Ontario.

"Non-small cell lung cancer continues to present a significant health risk for patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We would like to thank our colleagues at the NCIC CTG for completing enrolment in this study."

The study is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN® as a treatment for advanced or metastatic non-small cell lung cancer patients who have received previous chemotherapy.

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Ocata Therapeutics Receives SBIR Grant from NIH to Develop Proprietary Hemangio-derived Mesenchymal Cell Therapy for Lupus Nephritis

MARLBOROUGH, Mass.-- Ocata Therapeutics, Inc. (OCAT), a leader in the field of Regenerative Ophthalmology™, today announced that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to fund further preclinical development of Ocata’s proprietary Hemangio-derived Mesenchymal Cell (HMC™) product for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN).

“Ocata has demonstrated potential therapeutic activity of a pluripotent stem cell-derived product for the treatment of autoimmune diseases such as lupus nephritis and Crohn's disease,” said Robert Lanza, M.D., Chief Scientific Officer at Ocata, and Principle Investigator of the grant. “Our studies in highly regarded pre-clinical models of lupus nephritis provided proof of concept that our HMC’s increased the lifespan of the lupus-prone mice and inhibited the progression of otherwise fatal glomerulonephritis.”

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