dexamethasone (SX600) / Purdue, SpineThera - LARVOL DELTA

SALIENT: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (clinicaltrials.gov) - P1/2 | N=56 | Terminated | Sponsor: SpineThera Australia PTY LTD | Completed ➔ Terminated; Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients

Trial termination • Musculoskeletal Pain • Pain

IKEMA Long-term Sub-group Analysis: Isa-Kd for 1q21+ Multiple Myeloma (YouTube) - "Thomas Martin, MD...shares the findings of a sub-group analysis of the Phase III IKEMA study (NCT03275285) which investigated isatuximab in combination with carfilzomib and dexamethasone (Isa-Kd) in patients with relapsed/refractory multiple myeloma (R/R MM). In this analysis, the very good partial response (VGPR) rates, measurable residual disease (MRD) negativity and progression-free survival (PFS) with Isa-Kd versus Kd were compared in patients with 1q21 gain, with Isa-Kd resulting in favorable long-term outcomes. This interview took place at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023) held in Houston, TX."

Video

SpineThera Celebrates Milestone Achievement with 6th Patent Issued by the US Patent and Trademark Office (Businesswire) - "SpineThera, Inc...today announced United States Patent and Trademark Office (USPTO) has issued Patent No. 11,771,707 related to its micro-suspension platform technology. Patent No. 11,771,707 provides additional protection for SX600 and complements previously issued U.S. Patent Nos. 8,927,529, 9,572,771, 10,350,222, 10,925,883, and 11,058,692. The newly granted ‘707’ patent underscores SpineThera’s ongoing dedication to developing novel medical technologies that enhance spinal health and improve patients' quality of life."

Patent • Back Pain • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

SpineThera SALIENT Clinical Trial Results to Be Presented at Upcoming 22nd Annual ASRA Pain Medicine Meeting (Businesswire) - "SpineThera, Inc...today announced that the submitted abstract,” Clinically Meaningful Radicular Leg Pain Management via Novel Dexamethasone Extended Release Microsuspension (SX600)- PH1/2 Results” has been accepted for presentation at the 22nd Annual Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine (ASRA)....This abstract was selected from a highly competitive pool of submissions highlighting groundbreaking research and advancements in pain medicine that have the potential to improve the lives of patients suffering from various pain conditions. SpineThera will be presenting their findings from the SALIENT Trial where clinically meaningful reduction in unilateral radicular leg pain with a favorable safety profile was demonstrated for SX600 compared with placebo."

P1/2 data • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

EHA 2023: Effective Management of Bispecific Antibody Side Effects in Myeloma (HealthTree) - "ICANS is a potential neurological side effect and stands for Immune effector cell-associate neurotixicty syndrome. Shaji Kumar, MD...explained that this can include cognitive impairment, motor weakness, seizures, altered levels of consciousness, impaired handwriting, confusion, agitation, tremors, reduced attention and brain swelling."

Media quote

Dr. Giralt on Long-Term Outcomes with HSCT in Multiple Myeloma (OncLive) - "Sergio A. Giralt, MD, discusses long-term outcomes with hematopoietic stem cell transplant (HSCT) in multiple myeloma....Regardless, patients with standard- or high-risk disease should still consider initial treatment with HDM-HSCT to achieve long-term disease control, Giralt concludes."

Video

Isatuximab + Carfilzomib and Dexamethasone in Early vs Late Relapsed Multiple Myeloma (HMPL Global) - '"The primary endpoint of the study was progression-free survival as evaluated by an independent review committee and key secondary endpoints included overall response rates and rates of complete response, as well as MRD-negativity,' Dr Martin said....'In this post hoc subgroup analysis of IKEMA, the addition of Isa to Kd resulted in clinically meaningful improvement in PFS and depth of response with a manageable safety profile in both early and late relapse patients, consistent with the benefit observed in the overall IKEMA study population,' Dr Martin said."

Media quote

SALIENT: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (clinicaltrials.gov) - P1/2 | N=55 | Completed | Sponsor: SpineThera Australia PTY LTD | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Jun 2022 | Trial primary completion date: Jun 2022 ➔ Feb 2022

Trial completion • Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

SpineThera Awarded $5 Million Grant from Department of Defense (Businesswire) - "SpineThera, Inc...announced today that the Department of Defense has awarded the company a grant for $4.97 million that will support development of SX600. The scope of work supported by this grant award includes nonclinical toxicity testing of SX600 and manufacturing process development and scale-up activities. Together, these activities will position SX600 for future Phase 3 clinical trials....Total amount of grants and non-dilutive funding to over $18.5M to support the advancement of SpineThera’s SX600 for epidural injection to treat lumbosacral radiculopathy."

Financing • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

Multiple Myeloma: Griffin study update after 24 months of maintenance - "Among the highlights of the ASH Annual Meeting and Exposition, the griffin study update brings results of the DARA + RVd therapeutic regimen in newly diagnosed patients with multiple myeloma eligible for transplantation after 24 months of maintenance...analysis of Dr. Angelo Maiolino..."

Video

Poll Test (Cancer Network) - "Joshua Richter, MD: I think one of the things that's important for the people listening is obviously, this is a starting dose for patients with good renal function and no other comorbidities or not a lot of comorbidities compared to what we may see in the community. So it's important to refer to the lenalidomide package insert for how to dose when your creatinine clearance goes down. Ixazomib doesn't need any dosing unless you are on hemodialysis, in which case you would go down to 3 mg. The 40 mg of dexamethasone is usually pretty good for patients without brittle diabetes or over the age of 75. Once you get over 75, we're usually using 20 mg."

Video

Recent Advances in the Treatment of Relapsed/Refractory Multiple Myeloma - Episode 4: Updates From the CANDOR Study in R/R Multiple Myeloma (OncLive) - "...I want to focus for the next couple of minutes on different abstracts that have been presented that help fill out the discussion we've been having. Could you describe the design and updated efficacy and safety results of the CANDOR study? In this study, we're comparing daratumumab-Kd [carfilzomib, dexamethasone] with Kd [carfilzomib, dexamethasone] in patients with relapsed/refractory multiple myeloma. The abstract was updated recently by Dr Meletios Dimopoulos."

Routine Clinical Practice Comparison of IRD and Rd in RR Multiple Myeloma - Episode 1: Overview of a Routine Clinical Practice Study of IRD vs Rd (Cancer Network) - "Joshua Richter, MD: Hi, I'm Dr Joshua Richter...So it's important to refer to the lenalidomide package insert for how to dose when your creatinine clearance goes down. Ixazomib doesn't need any dosing unless you are on hemodialysis, in which case you would go down to 3 mg. The 40 mg of dexamethasone is usually pretty good for patients without brittle diabetes or over the age of 75. Once you get over 75, we're usually using 20 mg."

Video

SALIENT: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (clinicaltrials.gov) - P1/2; N=55; Active, not recruiting; Sponsor: SpineThera Australia PTY LTD; Recruiting ➔ Active, not recruiting; N=180 ➔ 55; Trial completion date: Sep 2022 ➔ Dec 2022

Clinical • Enrollment change • Enrollment closed • Trial completion date • Musculoskeletal Pain • Pain

Treatment of Relapsed and Refractory Multiple Myeloma [Google Translation] - "In this video, Dr. Walter Braga...comments on the new drugs and innovative treatment modalities that have emerged in recent years for the treatment of relapsed and refractory multiple myeloma , and discusses about its use in clinical practice."

Video

Research highlights (University of Nebraska Medical Center) - "The UNMC College of Medicine received grant and funding awards representing $11,037,387 in new funding in June...Sarah Holstein, MD, PhD...received funding for a phase II study of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in transplant-ineligible patients with newly diagnosed multiple myeloma."

Grant

SpineThera Announces Issuance of Fourth and Fifth Patents Covering its Sustained-Release Platform Technology (EIN News) - "SpineThera...announced today that the United States Patent and Trademark Office (USPTO) has recently issued U.S. Patent Number 10,925,883 entitled Pharmaceutical Compositions and Uses Thereof. The issuance of the ‘883 patent will add to the company’s growing worldwide patent portfolio and is already issued in nineteen other countries....The company’s lead product, SX600, is currently being evaluated in a Phase 2 clinical trial for lumbar radiculopathy (sciatica) in Australia....The USPTO also recently issued U.S. Patent Number 11,058,692 titled Pharmaceutical Composition and Use. The ‘692 patent covers the composition of microspheres with an anti-inflammatory agent, in addition to claims for specific pain treatment uses."

Patent • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

SALIENT: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (clinicaltrials.gov) - P1/2; N=180; Recruiting; Sponsor: SpineThera Australia PTY LTD; Trial completion date: Oct 2021 ➔ Sep 2022; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Evaluating Iberdomide Plus Daratumumab or Bortezomib in Relapsed/Refractory Myeloma (ASH Clinical News) - " P=1/2, N=27; 'The promising clinical activity and favorable toxicity profile of the iberdomide-based triplets supports further development of these regimens in myeloma,' said lead study author Niels van de Donk, MD, PhD....'In addition, the favorable safety profile of iberdomide makes it an attractive drug for maintenance'. In this report, Dr. van de Donk discussed the safety and efficacy of the two triplet regimens in patients with relapsed/refractory MM - 27 patients were assigned to IberDd and 23 were assigned to IberVd."

Clinical data

Weekly carfilzomib and dexamethasone plus/minus cyclophosphamide for RRMM patients (ecancer) - "Dr Albert Oriol speaks to ecancer about a randomised phase 2 study which was presented at ASH 2020 regarding weekly carfilzomib 70 mg/m2 and dexamethasone plus/minus cyclophosphamide in relapsed and/or refractory multiple myeloma (MM) patients (GEM-KyCyDex)....He says that in this phase 2 randomised study, we have compared Kd plus cyclophosphamide (KCyd) with Kd in RRMM after 1-3PL, both with K dosed weekly at 70 mg/m2. Dr Oriol then talks about the key results from this study and how they can impact the future treatment of refractory multiple myeloma. He winds the interview up by giving additional information on the subject and his opinion on how the research on this topic can proceed further."

Interview • Video

Selinexor vs. SOC in penta-exposed MM: STORM & MAMMOTH analysis (YouTube) - "Luciano Costa, MD...discusses the analysis of selinexor plus dexamethasone (Sd) vs. conventional care for triple class refractory, penta-exposed multiple myeloma in terms of overall survival (OS). This compared data from the STORM trial (NCT02336815) with real world data from the retrospective MAMMOTH study. While not an replacement for a prospective, randomized trial, this analysis suggested improved OS with Sd vs. conventional care in this group. This interview took place at the American Society of Hematology (ASH) 2019 Annual Meeting and Exposition in Orlando, FL."

Video

MRD-Based Dara-Krd Consolidation in Patients with Newly Diagnosed Multiple Myeloma: MASTER Trial (YouTube) - "This is the first report of monoclonal antibody-based quadruplet regimen with MRD-based response-adapted therapy in NDMM. Dara-KRd induction, autologous transplant and Dara-KRd consolidation guided by MRD is feasible, safe and leads to high proportion of patients achieving CR/sCR, IMWG MRD-negative CR, imaging plus MRD-negative CR and MRD less than 10-6. This approach can form the basis for clinical efforts to reduce the burden of continuous therapy in those with confirmed MRD-negative remissions."

Video

SALIENT: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (clinicaltrials.gov) - P1/2; N=180; Recruiting; Sponsor: SpineThera Australia PTY LTD; Trial completion date: Dec 2020 ➔ Oct 2021; Trial primary completion date: Jun 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Pain

Oral Steroid Attacks Inflammation, Decreases Mortality in COVID-19 Patients (Spectrum) - "'Dexamethasone, an oral steroid that’s readily available, decreased mortality by about a third in these very sick patients, particularly patients on respirators,' Dr. Steven J. O’Day said. 'It’s a real proof of principle that both attacks the virus specifically, but also now attacking inflammation in very sick patients can reduce mortality...We have to adapt to what’s happening to us in the moment, and we’ve had to adapt to this virus very quickly in terms of how it’s affecting people,' Dr. O’Day said. 'We learned very early on that ventilators in of themselves were not as successful as they were with other respiratory viruses. It’s actually causing more problems sometimes than helping.'"

Media quote

Imbrium Therapeutics L.P. and SpineThera, Inc. announce first patient dosed in phase 1/2 clinical study (Businesswire) - "Imbrium Therapeutics L.P....operating subsidiary of Purdue Pharma L.P., in conjunction with SpineThera, Inc., today announced the first dose administered in the SALIENT (Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain) Phase 1/2 clinical study of SX600, a non-opioid epidural steroid injection in development for the treatment of sciatica."

Trial status