REDONDO BEACH, CA / ACCESSWIRE / December 15, 2015 / As 2015 winds to a close, a little reflection shows it was a huge year for biotechnology. Of course, this year featured the biggest tax inversion deal ever with Pfizer (NYSE: PFE) and Allergan (NYSE: AGN) agreeing to combine companies in a whopping $160 billion deal. That mega-merger pushed the total for health and pharmaceutical mergers over $550 billion in 2015, up 17 percent from a year earlier, as big pharmas look to buy companies rather than risking resources on their own research and development. As with every year before it, 2015 was a time for new drugs to come to market, including Novartis' (NYSE: NVS) heart failure drug Entresto, and clinical trials advancing to offer hope for those in need in the future. Below are some companies that will be initiating key trials in 2016.
Synthetic Biologics, Inc. (NYSE MKT: SYN) recently provided encouraging topline data from its 63-patient phase 2 study using SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C). SYN-010 is a proprietary modified-release formulation of lovastatin lactone. In the short (4 week) trial, SYN-010 was shown to lower breath methane, which is thought to be a cause of constipation, in a dose-dependent fashion at both day 7 and day 28, in IBS-C patients, thus meeting the trial's primary objective. The treatment also improved stool frequency in IBS-C patients.
A second phase 2 trial in IBS-C is ongoing evaluating the 42 mg dose of SYN-010 during an eight-week period in patients carried forward from the first trial. Topline data from this study is expected in the first quarter of 2016 as Synthetic prepares a larger phase 3 trial. About 45 million people in the U.S. alone are affected by irritable bowel syndrome.
OncBioMune Pharmaceuticals, Inc. (OTCQB: OBMP) is aiming to wrap up a phase 1 study assessing its cancer vaccine ProscaVax for the treatment of prostate cancer and start a phase 2 trial in the first quarter of 2016. The phase 1 trial received substantial support from the U.S. government, with $5 billion in funding coming from the Department of Defense. The phase 2 trial, as described in the video below, will be hosted at "a major university" in the Northeast United States. Companies are often coy about using names of institutions in public statements, but a 10-Q filing with the Securities and Exchange Commission shows that "the lead site will be Harvard's Beth Israel Deaconess Medical Center, with additional other hospitals in the Harvard Health System." Harvard's health system is arguably one of the best in the world for cancer research and includes the venerable Dana-Farber Cancer Institute. The phase 2 trial will be under the direction of Dr. Glenn Bubley, who serves as an Associate Professor of Medicine at Harvard Medical School and Director, Genitourinary Medical Oncology, at Beth Israel.
With about 221,000 men estimated to be diagnosed with prostate cancer this year (and 27,500 deaths from it), there is a tremendous area of unmet medical need as effective drugs are scarce and accompanied by unpleasant side effects.
In-house clinical research and the phase 1 study have showed several important characteristics for ProscaVax. One, levels of PSA (prostate specific antigen, a protein produced by the prostate that's typically elevated in prostate cancer patients) were driven down in early stage patients with biopsy-confirmed prostate cancer and rising PSA levels without any other therapy. Long-term follow up and additional biopsies in four patients showed significant reduction in tumors following ProscaVax therapy. Further, the vaccine had almost no toxicity, a key in any monotherapy or those used in an adjuvant setting. In prostate cancer patients with advanced disease there was a significant decrease in the rise of the PSA for half the patients following ProscaVax therapy.
The phase 2 study will use ProscaVax alone to treat patients at presentation who are in active surveillance. This is an important distinction as most therapies are focused on late stages of the disease where prognosis is poor. There are currently no therapies available for treatment in the active surveillance period, a time when treating the disease could provide the greatest therapeutic benefit. Should ProscaVax reduce tumor volumes at this early stage without toxicity, OncBioMune will be in an enviable position to leverage accelerated FDA pathways in a bid to bring its product to market, as well as expanding its platform technology into other indications, such as ovarian cancer.
InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV), a company focused on treating traumatic acute spinal cord injuries (SCI), got some good news early this month when the FDA gave a conditional approval to a study protocol amendment that will convert an ongoing pilot study into a pivotal probable benefit study. The "conditional" approval only has to do with a slight change in the informed consent form, which has already been modified and sent to the FDA. Full approval is expected in the next few weeks. The five-patient feasibility pilot study is evaluating the company's Neuro-Spinal Scaffold (NSS) under an Investigational Device Exemption application for the treatment of complete traumatic acute spinal cord injury (SCI).
The NSS is an investigational bioresorbable polymer scaffold designed for implantation at the site of injury within a spinal cord contusion. It provides structural support to the spared spinal tissue and a supportive matrix to facilitate endogenous repair processes as it degrades over several weeks.
InVivo has provided compelling data so far showing NSS to have a positive safety profile and a meaningful effect on spinal cord injuries, injuries that have a long history of being notoriously difficult to treat. One patient in the trial with a high thoracic injury even had an AIS conversion (an improvement in the impairment scale of the American Spinal Injury Association) from AIS-A to AIS-B in one month, an occurrence that happens less than 4 percent of the time in patients with a T4 injury. Another patient has improved from AIS-A to AIS-C in one month, which happens in less than 5 percent of patients with a T10-T12 injury.
The pivotal probable benefit study, dubbed the INSPIRE study, is planned initially to enroll 12 patients, with expectations to be expanded to 20 patients after a review of 6-month safety data of the first five patients. The inclusion criteria are also being widened to a new range of injuries and the age criteria has been significantly expanded to people between the age of 16 and 70. The number of U.S. sites has been increased to 40 and InVivo further intends to initiate the study in Canada and the United Kingdom.
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