Micromethason (liposomal dexamethasone) / Novosom - LARVOL DELTA

AMETHYST: A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma (clinicaltrials.gov) - P1/2; N=7; Terminated; Sponsor: Enceladus Pharmaceuticals BV; N=35 ➔ 7; Trial completion date: Mar 2019 ➔ Aug 2020; Not yet recruiting ➔ Terminated; Trial primary completion date: Dec 2018 ➔ Aug 2020; Patient enrolment issues

Clinical • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Myeloma cell adhesion to bone marrow stromal cells confers drug resistance by microRNA-21 up-regulation (Leuk Lymphoma) - miR-21 inhibition combined with cytotoxic drug dex or dox inhibited myeloma cell survival more effectively than either treatment alone; These results suggest that the regulatory mechanisms of miR-21 expression may be a promising target for fine-tuning anti-myeloma therapy

Review • Multiple Myeloma

Bortezomib, liposomal doxorubicin and dexamethasone (BDD) followed by thalidomide and dexamethasone (TD) is an effective treatment for newly diagnosed multiple myeloma patients with ISS stage II or III, or extramedullary disease (Leuk Lymphoma) - P2, N=42; After the planned 3 cycles of BDD, ORR was 81% with 40% ≥ very good partial response, including 26% near complete and complete responses (nCR/CR); After the additional 2 cycles of TD or BTD, ORR was 83% with 60% ≥ VGPR including 43% nCR/CR, indicating deeper responses following sequential therapy (p=0.008)

P2 data • Multiple Myeloma

Liposomal dexamethasone inhibits tumor growth in an advanced human-mouse hybrid model of multiple myeloma. (PubMed, J Control Release) - "The liposomal formulation slightly reduced total body weight of myeloma-bearing mice during the course of treatment, which appeared reversible when treatment was stopped. Liposomal dexamethasone could be further developed as monotherapy or could fit in with existing therapy regimens to improve therapeutic outcomes for multiple myeloma."

Journal • Preclinical • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Liposomal dexamethasone-moxifloxacin nanoparticles combinations with collagen/gelatin/alginate hydrogel for corneal infection treatment and wound healing. (PubMed, Biomed Mater) - "An animal study also confirmed that CGA-Lipo-MFX/DEX could inhibit pathogen microorganism growth and improve corneal wound healing. Our results suggest that CGA-Lipo-MFX/DEX could be a useful anti-inflammatory formulation for ophthalmological disease treatment."

Journal • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology • CGA, CHGA

Promoting effects of IL-13 on Ca2+ release and store-operated Ca2+ entry in airway smooth muscle cells (Pulm Pharmacol Ther) -

Dexamethasone & short-acting beta2 agonist salbutamol suppressed IL-13-augumented basal [Ca(2+)](i), Ca(2+) release & Store-operated Ca(2+) entry (SOCE), whereas the long-acting beta2 agonist salmeterol had no effect on altered Ca(2+) signaling in IL-13-treated ASMCs;

Asthma

Efficacy of retreatment with immunomodulatory drugs (IMiDs) in patients receiving IMiDs for initial therapy of newly diagnosed multiple myeloma (Blood) - P=NA, N=140; The median time from diagnosis to repeat exposure to IMiD was 28 months; Among the 113 pts, 50 (44%) pts achieved at least a partial response and 63 (56%) pts achieved less than a partial response to repeat IMiD; Response rates with lenalidomide retreatment were higher compared with repeat administration of thalidomide

Multiple Myeloma

Alternative schedule of Velcade/Dexamethasone plus doxil for patients with multiple myeloma (clinicaltrials.gov) - P2, N=32; Active, not recruiting; Completion date: NA → Jun '11

Multiple Myeloma

Trial of oxaliplatin, cytosine arabinoside, dexamethasone with rituxan (ROAD) in patients with relapsed non-hodgkins lymphoma (clinicaltrials.gov) - P2, N=50; Suspended

None

Neutrophil-Mediated Delivery of Dexamethasone Palmitate-Loaded Liposomes Decorated with a Sialic Acid Conjugate for Rheumatoid Arthritis Treatment. (PubMed, Pharm Res) - "SA-modified liposomal DP was a promising candidate for RA-targeting treatment through the neutrophil-mediated drug delivery system."

Journal