|Derma Science recieves BARDA grant. Delcath faces FDA setback. Gilead acquires Calistoga Pharma|
|By Staff and Wire Reports|
|Tuesday, 22 February 2011 19:38|
Derma Sciences, Inc. (Nasdaq:DSCI), a medical device and pharmaceutical company focused on advanced wound care, today announced that researchers who invented DSC127 have been awarded a $4.5 million,16-month grant by the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) to investigate preclinically the use of DSC127 in the treatment of skin injuries associated with acute radiation exposure. This contract, which is part of the HHS radiological and nuclear threats preparedness strategy, could be extended for a total of five years and up to a total of $14 million. Derma Sciences recently announced positive Phase 2 data in the use of DSC127 in diabetic foot ulcer healing, in which 54% of wounds healed completely in 12 weeks, compared with only 33% of wounds in patients receiving placebo and best standard of care in the intent to treat populations.
Shares of Derma gained 44 cents or 4.55% to $10.10.
Shares of Delcath Systems, Inc. (Nasdaq:DCTH) fell today after the company announced today that it has received a "refusal to file" letter from the FDA for the New Drug Application for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride. Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted. Based on management's current understanding of the information in the FDA's letter, the Company intends to resubmit the NDA by September 30, 2011.
Shares dropped $4.29 or 38% to $7.01.
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it will acquire Calistoga Pharmaceuticals, Inc., a privately-held biotechnology company focused on the development of medicines to treat cancer and inflammatory diseases, for $375 million. Calistoga could earn up to an additional $225 million if certain milestones are achieved. Calistoga focuses on the development of medicines to treat cancer and inflammatory diseases such as CAL-101, that may help fight non-Hodgkin's lymphoma and help treat elderly patients in a specific type of leukemia.
"Oncology remains an area of significant unmet medical need and our increased understanding of the genetic basis of cancer allows for the development of disease specific targeted therapies," said Gilead's Chief Scientific Officer Norbert W. Bischofberger. "We are very encouraged by emerging clinical data for CAL-101, and this compound could represent an advance for the treatment of certain hematological cancers."
Cannabis Science, Inc. (OTCBB:CBIS.ob) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana derivative) products, is pleased to announce that numerous patients are reporting that Cannabis Science extract treatments are killing cancer cells. Cannabis Science, in conjunction with Rockbrook, its Colorado-licensed dispensary, consulted with a variety of cancer patients who were seeking to inform themselves of the current peer reviewed scientific literature, regarding the historical use of cannabis to treat "tumors". Unlike most conventional cancer treatments, cannabis has an outstanding safety profile, and patients in states with medical marijuana laws are able to make an informed decision to legally try various cannabis preparations to determine what is most effective for their particular condition.
Some of these scientifically informed patients have chosen to self-administer Cannabis Science extracts supplied by Rockbrook to treat their own cancers. Cannabis Science is delighted that patients are reporting dramatic improvements in their conditions, including basal cell carcinoma, non-small cell lung cancer accompanied by COPD (chronic obstructive pulmonary disease), ovarian cancer, and glioma.
Shares jumped 3.5 cents or 103% to $0.068.
Vical Incorporated (Nasdaq:VICL) announced today that the company has extended its relationship with the U.S. Naval Medical Research Center (NMRC) to develop its platform technology for the rapid development and production of vaccines against emerging infectious diseases.
Vical received U.S. government funding from Defense Threat Reduction Agency and NMRC in 2010 to support development of its Vaxfectin-formulated DNA vaccine against H1N1 pandemic influenza, which is expected to complete Phase 1 testing in the first quarter of 2011. With additional funding under the extended relationship, Vical will work with NMRC under this contract to establish systems and procedures for the application of Vical's DNA delivery technology, with the goal of protecting military personnel from the threat of new pathogens in the early stages of outbreaks.
Shares rose 8 cents or 4.23% to $1.97.
Omeros Corporation (Nasdaq:OMER) today announced that its exclusive license to phosphodiesterase 7 (PDE7) inhibitors from Daiichi Sankyo Co., Ltd. has been amended to include addiction and compulsive disorders in the field of use. Omeros' PDE7 program was founded on the Company's discovery of a previously unknown link between PDE7 and any movement disorder, such as Parkinson's disease. Omeros believes that it also is the first to link PDE7 to any addiction or compulsive behavior, and is now advancing PDE7 inhibitors for the treatment of these as well as movement disorders. Omeros is collaborating on this program with both the National Institute on Drug Abuse (NIDA) and The Michael J. Fox Foundation.
OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug Administration for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.
Aeterna Zentaris Inc. (NASDAQ: AEZS) TSX: AEZ) a late-stage drug development company specialized in oncology and endocrinology, announced today that it has filed a prospectus supplement dated February 22, 2011 to its U.S. shelf prospectus, dated March 12, 2010, forming part of its U.S. registration statement on Form F-3 with the United States Securities and Exchange Commission as well as a prospectus supplement to its Canadian final base shelf prospectus dated March 12, 2010.