|Cara Announces Positive Top-Line Data from Phase 1b Trial of IV CR845; Provectus To Sponsor American Association Of Physicians Of Indian Origin|
|By Marilyn Mullen|
|Wednesday, 17 December 2014 19:46|
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the successful completion of a Phase 1a / 1b clinical trial of an oral tablet formulation of its peripherally-selective kappa opioid agonist, CR845, for the treatment of acute and chronic pain.
The double-blind, randomized, placebo-controlled trial evaluated the pharmacokinetic and safety profile of single and multiple escalating doses of Oral CR845 in 150 healthy volunteers at a single U.S. site. The single ascending dose study, which included six tablet strengths ranging from 0.1 mg to 10 mg, demonstrated a mean oral bioavailability of 10% across all dose groups under fasting conditions, with a range of maximum plasma concentrations of CR845 bracketing the concentrations seen in previously successful Phase 2 trials with I.V. CR845. All tested dose strengths were also shown to be active at the kappa opioid receptor, as assessed by statistically significant (p<0.0001) acute changes in blood measurements of an established neuroendocrine biomarker.
The multiple ascending dose study, which used repeat dose studies of the 0.1 mg, 1 mg and 5 mg tablets, administered twice a day (b.i.d.) for one week, demonstrated that all tablet doses were well tolerated with no serious adverse events (SAEs) reported and all adverse events (AEs) were mild and generally similar to those reported with I.V. CR845. Additionally, clinical safety laboratory measurements were normal across all tablet strengths after single or repeat dosing.
"Successful completion of this Phase 1 trial of the tablet formulation of Oral CR845 represents a key milestone for Cara as we look to expand the clinical development of CR845 beyond the treatment of acute pain in a hospital setting," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We are very encouraged that the plasma levels of CR845 attained within this tablet strength range equaled or exceeded those previously associated with clinical analgesic effects seen in acute post-operative pain models with I.V. CR845."
Dr. Chalmers also noted, "These findings complement our recently successful human abuse liability study of I.V. CR845, as well as our recently completed quantitative primary research study indicating that Oral CR845 has the potential to meet a significant physician demand for a safer, non-abusable alternative to narcotic opioids and NSAIDs for the treatment of moderate-to-severe acute and chronic pain."
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced it has agreed to sponsor the activities of the American Association of Physicians of Indian Origin (AAPI). In addition, Provectus will participate at AAPI's 2015 Global Healthcare Summit in Mumbai, India, running from January 2-4, 2015, as well as at the Annual AAPI Conference in Orlando, Florida, running from June 17-21, 2015.
Peter Culpepper, COO and CFO of Provectus, said, “We are very pleased to be sponsoring AAPI in the coming year, and we believe the relationship will benefit both AAPI and our shareholders. One of the benefits to Provectus will be engaging the Indian market through trusted physicians for PV-10, our novel investigational cancer treatment. We expect this will not only assist us in gaining regulatory approval in India but also will support our patient recruitment efforts as we embark on our phase 3 clinical trial of PV-10 for the treatment of melanoma.”
He continued, “AAPI is the umbrella organization representing the interests of over 60,000 doctors of Indian origin in the USA, and there are over 25,000 medical residents and fellows currently in USA. This gives us tremendous reach in America as well as on the subcontinent. One in every seven American patients is seen by an Indian doctor, and this ratio is even higher in the smaller towns and underserved areas due to the larger proportion of Indian doctors in more remote locations. As a result, the Indian doctor also serves the most diverse group of patients in the USA including Caucasians, African Americans, Hispanics and other groups, which is important for clinical research and trials.”
Mr. Culpepper concluded, “We will hit the ground running with AAPI by attending their Global Healthcare Summit (GHS) in Mumbai, India, starting January 2, 2015. At this GHS, we expect around 800 delegates to attend. Between 150 and 200 will be from the USA, and some from the United Kingdom, Canada, Middle East and Australia. In addition, AAPI will have a live extension to its members in the USA who are unable to attend, as well a live telecast to an estimated 50,000 doctors around India. We will inform this huge group of doctors from around the globe about the progress we have made with PV-10 to date, what we are planning in the anticipated phase 3 clinical trial, and what we have learned about PV-10 for indications other than melanoma.”
Dr. Ravi Jahagirdar, MD, President of AAPI, said, “We are very happy to have Provectus as an official sponsor of AAPI and to enjoy their participation at our coming meetings in Mumbai and Orlando in 2015. The Indian diaspora offers a unique, global network of physicians who can increase the communication of medical developments like the clinical results shown thus far for PV-10. Moreover, we have close professional, educational and family ties to India itself, a nation of 1 billion. We believe this introduction of Provectus to the healthcare industry in India will be well received, since PV-10 has many features that make it well suited for local conditions.”
Provectus has also expanded the membership of its Strategic Advisory Board with the addition of Deanna Angello, Director, Commercial Strategy and New Business Planning for the Global Established Pharma business at Pfizer Inc. In this role, she is focused on new business opportunities for the US region, notably in areas such as licensing of new assets, mergers and acquisitions, and strategic partnerships. She was promoted to this position from her role as Senior Manager, Marketing, Lyrica, a product approved for fibomyalgia, diabetic peripheral neuropathy and other pain-related conditions. Prior to that she was in Strategy & Analytics, where she worked on diabetes and Alzheimer’s disease products. Before joining Pfizer, Deanna was a management consultant at Booz Allen and Bearing Point where her efforts concentrated on strategic planning, organizational effectiveness and business process improvement. Ms. Angello holds a B.S. in Psychology from the University of Pittsburgh and a Masters in Business Administration from the Kelley School of Business at Indiana University. As part of her graduate studies, she studied for a semester at St. Gallen University in Switzerland. Ms. Angello also serves as a Board Member of the Association for Frontotemporal Degeneration (AFTD), a national and dynamic 501(c)(3) healthcare non-profit dedicated to raising awareness and ultimately finding a cure for frontotemproal degeneration (FTD), a rare neurodegenerative disease.
Dr. Craig Dees, Ph.D., CEO of Provectus, said, “We are delighted to have Deanna join our Strategic Advisory Board. She is a highly experienced, forward-thinking healthcare and pharmaceutical strategist, with commercial experience in marketing and business development and we look forward to working with her in the coming months.”
Ms. Angello stated, “I am very pleased to be joining the Provectus Strategic Advisory Board just as they are beginning their phase 3 clinical trial of Intralesional PV-10 for the treatment of melanoma. It is a very exciting time for the Company both scientifically and commercially, and I look forward to contributing to its success.”
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