Novoteris LLC in Garden Grove will proceed with another phase two trial in both the U.S. and Canada for its drug-device product designed to treat cystic fibrosis.
The medical device and drug developer focuses on expanding nitric oxide gas applications—an inhalable gas used to relax muscles, in particular to widen blood vessels in the lungs. The multicenter, 60-subject randomized trial will test the product for cystic fibrosis, a rare inherited disorder that damages the lungs and digestive system. It affects the lungs most critically, resulting in frequent lung infections and breathing difficulty. Patients are often treated with a life-long inhaled antibiotic.
“The treatment takes 7.5 days, and [while] we don’t know if it will be a one-time treatment, it will be used at a much less frequent rate [than inhaled antibiotics],” said founder and President Alex Stenzler. He said all inhaled antibiotics are liquid-based aerosol sprays that provide less effective distribution of the drug than gas does.
Novoteris acquired its intellectual property and science from Garden Grove-based 12th Man Technologies Inc.— formerly the advanced technologies respiratory team of Yorba Linda-based Care Fusion—and Nitric Solutions Inc. in Vancouver, Canada, which makes bedside nitric oxide gas analysis and delivery equipment.
Stenzler is also 12th Man’s president. The Business Journal reported a month ago another spinoff of 12th Man that received Food and Drug Administration approval for a device that measures lungs’ air capacity. The company is partial owner of four other medical companies, Stenzler said.
Nitric oxide is a molecule naturally produced by the body, serving as the defense system against microorganisms, and has been used together with a ventilator to treat respiratory failure in premature babies.
“Nitric oxide is not new. What’s new is the concentration—we are delivering eight times higher concentration than is used to treat patients with blood vessel problems,” Stenzler said. He added that there are about 30,000 to 35,000 people in the U.S. suffering from cystic fibrosis.
Nonprofit organization Cystic Fibrosis Foundation Therapeutics Inc. provided $2.8 million to support the trial.
Meanwhile, Avanir Pharmaceuticals Inc. in Aliso Viejo will also take its drug candidate, AVP-786, into phase two. It’s begun enrollment for a 12-week multicenter, 150-patient randomized trial in the U.S. The study will test the drug’s efficacy in treating aggression, agitation and irritability in patients with traumatic brain injury.
“Dysfunctional behaviors … are estimated to occur in more than half of adults with [traumatic brain injury],” said Chief Medical Officer Richard Malamut. He added that the behaviors “dramatically impact family, interpersonal and work relationships.”
The drug is also in clinical trials for residual schizophrenia—a phase-two trial—and for agitation associated with Alzheimer’s disease—a phase-three trial.
Japanese drugmaker Otsuka Holdings Co. Ltd. acquired Avanir in 2015 for about $3.5 billion.
Acquisition
OC investor Brad de Koning is out shopping with Newport Beach-based Mercury Partners—an investment firm that shares the name of the company he started and sold to The Sage Group LLC in Los Angeles in 2003. The company recently completed its first acquisition: DirectMed Parts & Service LLC in San Diego, a supplier of after-market medical imaging parts. Terms of the transaction weren’t disclosed.
In conjunction with the acquisition, de Koning, managing partner at Mercury, will replace Bill Erbes as chief executive.
A company spokesperson said Mercury plans to acquire three more companies in business and financial services for $5 million to $25 million in the next five years. Targets are likely U.S. medical and healthcare-related companies generating $10 million to $50 million in revenue.
Mercury is funded solely by de Koning, who was most recently chief executive of L.A. Spas in Anaheim, a manufacturer of portable hot tubs, swim spas and gazebos.
Cancer Treatment
Peregrine Pharmaceuticals Inc. in Tustin announced positive data from a third-phase trial of bavituximab, a monoclonal antibody that aims to treat nonsmall-cell lung cancer, one of two major types of lung cancers. The drug targets phosphatidylserine, a molecule that sends signals inhibiting the ability of immune cells to recognize and fight tumors. Data were presented at the annual meeting of the American Society of Clinical Oncology this month in Chicago.
The biopharmaceutical company has a market cap of about $168 million.
Bits & Pieces
Irvine-based structural heart disease implant maker Edwards Lifesciences Corp. presented at the Goldman Sachs 38th Annual Global Healthcare Conference in Rancho Palos Verdes last week. … Allergan PLC presented new data on chronic migraine at the American Headache Society meeting in Boston. The indication is part of the Dublin, Ireland-chartered company’s therapeutic Botox portfolio that’s based at its Irvine campus.
