|Santarus Announces Positive Top-Line Phase III Results for Rifamycin SV MMX; Cell Therapeutics Announces European Launch Of Pixuvri®|
|By Staff and Wire Reports|
|Tuesday, 11 September 2012 19:43|
Santarus, Inc. (NASDAQ:SNTS) announced its Phase III clinical study to evaluate the safety and efficacy of the investigational drug, rifamycin SV MMX®, met the primary endpoint of reducing time to last unformed stool (TLUS) in patients with travelers diarrhea.
In the intent-to-treat (ITT) population (n=264), the median TLUS was 46.0 hours for rifamycin SV MMX (n=199) compared with 68.0 hours for placebo (n=65), p = 0.0008. Results in the per protocol population (n=240) were similar to the ITT population.
Rifamycin SV MMX was generally well tolerated in this Phase III clinical study and the frequency of treatment emergent adverse events was similar to placebo. The most frequent treatment emergent adverse events experienced by e 2% of patients in either treatment group were: headache (8.0% in active arm and 9.2% in the placebo arm), diarrhea (5.0% in the active arm and 9.2% in the placebo arm), infectious diarrhea (5.0% in the active arm and 7.7% in the placebo arm), constipation (3.5% in the active arm and 1.5% in the placebo arm), amoebic dysentery (0% in the active arm and 3.1% in the placebo arm) and gastrointestinal infection (0% in the active arm versus 3.1% in the placebo arm). There were three patients who experienced serious adverse events, all of which were assessed by the investigator as not related to the study drug. One patient in the placebo group developed clostridium difficile colitis and two patients in the rifamycin SV MMX group experienced a total of three adverse events: neuroblastoma, abdominal pain and vomiting. Santarus expects additional data from this clinical study will be presented at an appropriate medical meeting in 2013.
Santarus licensed rights to develop and commercialize rifamycin SV MMX in the U.S. from Cosmo Technologies Limited. Dr. Falk Pharma GmbH, Cosmos European development partner, is conducting a second Phase III clinical study to evaluate the efficacy of rifamycin SV MMX versus ciprofloxacin with the primary endpoint of TLUS in patients with travelers diarrhea. This non-inferiority study is expected to enroll approximately 1,000 patients and to be completed in mid-2013. Assuming positive results in the second Phase III clinical study, Santarus and Dr. Falk plan to share the clinical data from their respective Phase III studies for inclusion in each companys regulatory submissions.
These favorable Phase III results in travelers diarrhea represent a significant positive milestone in the clinical development of rifamycin SV MMX for the U.S. market. Rifamycin SV is an investigational broad spectrum, non-systemic antibiotic that has been used for more than 20 years in Europe in both intravenous and intramuscular forms, but is considered a new chemical entity in the U.S., said Wendell Wierenga, Ph.D., executive vice president, research and development of Santarus. As we wait for completion of the second ongoing Phase III study being conducted by Dr. Falk Pharma, we plan to assess our options to evaluate rifamycin SV MMX in other indications where a non-systemic antibiotic with a broad spectrum of activity may offer a clinical benefit.
Cell Therapeutics, Inc. (CTIC) (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, announced the initiation of the commercial launch of Pixuvri® in the European Union ("E.U.") with entry into Sweden, Denmark and Finland in September, to be followed by Austria and Norway in early October 2012 and Germany, United Kingdom and the Netherlands in November 2012. CTI plans to expand availability to France, Italy and Spain as well as other European countries in 2013. Pixuvri was granted conditional marketing authorization by the European Commission in May 2012 and is the first medicinal product licensed in the E.U. to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin Lymphoma ("NHL"). In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL every year.1,2
"Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," commented Dr. Ruth Pettengell, Consultant Hemato-Oncologist at St George's Hospital, London and principal investigator of the Phase III EXTEND study. "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."
In the EXTEND (Expanding the reach of anthracyclines with piXanTronE in relapsed or refractory aggressive NHL Disease) study for Pixuvri, when compared with other active single-agent treatments, more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed.3 Prior to the approval of Pixuvri there was no standard of care for treating patients who failed front line and second line therapy for aggressive B cell NHL. The EXTEND trial is the only randomized controlled clinical study in this patient population establishing the standard of care for this patient population.
"We are pleased to be able to offer the first meaningful treatment option for physicians treating those patients with multiply relapsed and refractory aggressive NHL," stated James A. Bianco, M.D., President and CEO of CTI. "CTI looks forward to making this innovative product available to healthcare providers across the European Union."
Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) announces launch of new line of products and services in the Healthcare Business Process Outsourcing (BPO) industry.
Dehaier Medical Systems Ltd. (NASDAQ: DHRM) ("Dehaier"), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it has obtained State Food and Drug Administration approval for DHR-CPAP-C5, one of Dehaier's major proprietary homecare medical devices. The period of validity for the SFDA approval is four years.
FluoroPharma Medical, Inc. (OTCBB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today confirmed that FluoroPharma diagnostic products were included in presentations at two significant Scientific forums.
Hydromer, Inc. (OTCQB: HYDI) (PINKSHEETS: HYDI) announced that during August of its first fiscal quarter, it had entered into two royalty bearing License Agreements, one with a US-based medical device company, and one with a China-based medical device company.
Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced financial results for the first quarter ended July 31, 2012 of fiscal year (FY) 2013 and provided an update on its advancing clinical pipeline and other corporate developments.
Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) today provided highlights and excerpts from the panel discussion, entitled 'Alzheimer's and Other Issues of Aging,' which took place on Sunday, September 9th at the Celebration of Science Conference in Washington, D.C. Freda Lewis-Hall, Executive Vice President and Chief Medical Officer of Pfizer, moderated the panel.
RepliCel Life Sciences Inc.'s (OTCBB:REPCF) today announces that David Hall, CEO and President, will be presenting at the Rodman & Renshaw Global Investment Conference.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of pediatric Crohn's disease. Soligenix has previously received Orphan Drug Designation for oral BDP as a treatment for pediatric Crohn's Disease.
TNI BioTech, Inc., (PINKSHEETS: TNIB), a public company operating in the biotech sector, announced today the signing of a Memorandum of Agreement between the company and MOV-FAS S.A. to open a pharmaceutical plant in Managua, Nicaragua.