Aeolus Pharmaceuticals Inc. has met with the Food and Drug Administration and is feeling good about the outlook for its AEOL 10150 as a countermeasure for radiation poisoning.
The Mission Viejo-based drug maker is developing the compound for military applications and other uses. The company said it met with the regulators as a step toward filing an investigational new drug application.
Aeolus executives said the FDA agreed with the animal models it has developed for proposed efficacy testing of AEOL 10150. Plans include the use of mice and non-human primates as the two species for such testing.
Regulators agreed with Aeolus that supportive care should be incorporated in the non-human primate studies and encouraged Aeolus to submit animal efficacy testing protocols to the agency for review prior to initiating the study.
Other steps covered in the meeting included guidance from regulators on non-clinical studies to support Aeolus’ application, as well as input on its first-phase human safety study design.
FDA also suggested Aeolus consider parallel development of AEOL 10150 to decrease acute and chronic toxicity from radiation therapy to the chest for certain types of cancer. The regulatory agency indicated that data from such studies could be used to support the lung acute radiation syndrome indication for AEOL 10150.
The drug developer is “grateful” to the FDA’s Division of Medical Imaging Products for its thoughtful feedback on our development plans,” Chief Executive John McManus said in a press release.
Aeolus raised $26.7 million earlier this year and is using that money to help cover expenses as it works on developing AEOL 10150 for biodefense purposes.
McManus said that Aeolus’ filing of an S-1 form with the Securities and Exchange Commission in May was triggered by a financing deal completed in February.
“The financing’s really been done—it’s not a sale of stock by the company to investors,” he said. “The S-1 allows the investors the right, if they choose, to be able to resell their stock.”
Aeolus develops cancer and biodefense drugs, and has yet to produce a commercial product. It now has a five-year, $118 million research and development contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
Aeolus raised the additional funds to cover about $100,000 of monthly expenses that aren’t reimbursed under its federal government contract.
Griffin-American Buys
Another month, more buys for Newport Beach healthcare real estate investor Griffin-American Healthcare REIT II Inc.
Griffin-American said it bought 20 buildings in deals that combined for $103 million.
The buildings include eight skilled nursing facilities, five assisted living facilities and seven medical office buildings.
One set of buildings is known as the Pacific Northwest Senior Care Portfolio and encompasses skilled nursing and assisted living facilities in Washington and Oregon that total about 369,000 square feet of space and 838 licensed beds.
Regency Pacific Management of Bellevue, Wash., has a master lease on the building that runs through 2025.
Griffin-American bought the portfolio from various entities associated with Regency Pacific. The seven medical office buildings total 199,000 square feet of space between them.
They are located in Illinois, Texas, Tennessee and Georgia. The largest of those buildings is located in Urbana, Ill., and has three stories and 47,000 square feet.
Griffin-American was previously a unit of Santa Ana-based Grubb & Ellis Co., now called Newmark Grubb Knight Frank. Griffin Capital Corp. and American Healthcare Investors LLC took over sponsorship of the unit in late 2011.
It now has a portfolio of 110 healthcare-related buildings valued at some $925 million across 26 states.
Allergan in N.J.
Allergan Inc. has opened up a $12 million, 93,000-square-foot research and development center in Bridgewater, N.J. Allergan is the Irvine-based maker of Botox and other drugs.
The company has said the New Jersey center could create some 400 new jobs over a three- to five-year period. New Jersey is a long-established center for drug makers, with big companies such as Johnson & Johnson and Merck & Co. having major operations in the state.
Scott Whitcup, Allergan’s executive vice president for research and development, said in an interview last year that Allergan’s Dupont Drive campus in Irvine “is our key R&D facility” and that the decision to open in New Jersey wasn’t a decision of one location versus the other.
“California’s growing, but R&D’s growing even faster than we can keep up,” Whitcup said.
Bits and Pieces
St. Joseph Hospital-Orange was one of 164 hospitals nationwide that received a platinum performance achievement award for cardiac care from the American College of Cardiology Foundation’s NCDR Action registry. The award honors hospitals that have implemented a higher standard of care for heart attack patients. … AltaMed Health Services received a $350,000 Ryan White grant to provide human immunodeficiency virus services for underinsured women and youth in Orange County. Los Angeles-based AltaMed has 10 clinics spread among Anaheim, Garden Grove, Huntington Beach, Orange and Santa Ana.
