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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-57/
- Published: 2022-01-09T12:00:00.000Z
- Updated: 2026-09-14T17:27:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5131990

**GliaCure** has begun dosing Alzheimer’s patients in a Phase 1b clinical trial of its GC021109 to evaluate safety and tolerability. The company says its approach promotes the clearance of amyloid and stimulates anti-inflammatory actions through a single target.

**Bayer HealthCare** has entered into an exclusive license agreement with **Isis Pharmaceuticals** under which Bayer willfurther develop and commercialize ISIS-FXIRx, an antisense investigational drug in development for preventing thrombosis in areas of high unmet medical need. Bayer says it will evaluate the therapeutic profile of the product in an appropriate patient community.

Biotherapeutics company **Oncobiologics** has completed construction of a GMP commercial launch manufacturing facility at its headquarters in Cranbury, New Jersey. The company says the new 2000-L facility has already been deployed to manufacture ONS-3010, a biosimilar candidate to Humira(adalimumab) for use in an upcoming Phase 3 clinical trial.

**CytRx Corp.** reported on an interim analysis from two Phase 1b combination studies of standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. It says the combinations appear to be well-tolerated and the lowest dose level of aldoxorubicin (170 mg/m2) demonstrated impressive tumor responses in patients with bone cancer and a variety of soft tissue sarcomas.

**Traverse Biosciences** says it has executed a $250,000 cooperative research and development agreement with **Aratana Therapeutics** to advance the development of TRB-N0224 , a chemically-modified curcumin, for treating and controlling periodontal disease in companion animals. It says the funds provided by Aratana will be used by Traverse to conduct a proof-of-concept efficacy study to evaluate TRB-N0224 in an accepted animal model of canine periodontal disease.