REGULATED INFORMATION

Strategic focus revised and fully focused on achieving topline results of the ALLOB Phase IIb study in tibial fractures.

Discussions for ALLOB global partnership still ongoing.

Board of Directors and Management exploring all strategic options to protect shareholder value.

Strengthening financial position with EIB agreement and private placement in 2021 and a new bond issuance foreseen in May 2022

Management to host conference call today at 3pm CEST / 9am EST - details provided below

Mont-Saint-Guibert, Belgium, 29April 2022, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update and full year financial results for the year ending 31 December 2021, prepared in accordance with IFRS as adopted by the European Union.

Incomplete fracture healing remains a seriously unmet medical need affecting hundreds of thousands of patients worldwide. Despite the pandemic and subsequent seriously geopolitical and economic global events, Bone Therapeutics still remains on target for delivery of topline results for its Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. We believe ALLOB could provide difficult tibial fracture patients a convenient treatment option with a potentially superior outcome. Having successfully completed two clinical studies showing promising safety profile and efficacy signals in more than 60 patients, we firmly believe that ALLOB has the highest potential of near-term value creation and is focused on completing the current Phase IIb study. In addition, Bone Therapeutics has made a serious contribution for the future into the use of Induced Pluripotent Stem Cell (iPSC) derived, genetically engineered MSCs. Bone Therapeutics is continuing its efforts to establish value adding business collaborations and to strengthen its financial position.

Clinical and operational highlights (including post-period events)

In January 2021, Bone Therapeutics initiated the treatment of patients in the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. Bone Therapeutics anticipates finalizing patient recruitment of this study in 2022. This recruitment finalization is subject, as across the industry, to evolution of the ongoing COVID-19 pandemic and the associated containment measures. Although early recruitment rates were very promising, the recruitment rates have temporarily slowed in subsequent months due to pandemic-related factors, such as reduced site activities due to staff availability and the number of available patients due to less occurrence of accidents. Bone Therapeutics has implemented several mitigating measures in collaboration with the involved clinical research organization to improve and facilitate recruitment. These measures include site expansion, training, information, best practices sharing and close monitoring of progress. As a result of these measures and the improving recruitment rate, Bone Therapeutics continues to currently expect the release of topline data by Q1 2023.

In January 2021, Bone Therapeutics signed an initial agreement for a process development partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand. This collaboration focused on further developing and enhancing Bone Therapeutics bone-forming platform.

In June 2021, Bone Therapeutics published the positive results of its Phase I/IIa clinical trial with ALLOB in patients with delayed union fractures. The results were published in Stem Cell Research & Therapy, the international peer-reviewed journal focusing on translational research in stem cell therapies. ALLOB was generally well-tolerated and that all patients met the primary endpoint.

In August 2021, Bone Therapeutics announced topline results from the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004, its legacy non-MSC product. JTA-004 had a favorable safety profile. However, the study did not meet the primary and key secondary endpoints. No statistically significant difference in pain reduction could be observed between the treatment, placebo and comparator groups, with all treatment arms showing similar efficacy.

In September 2021, Bone Therapeutics signed a research evaluation agreement with Implant Therapeutics, the developer of hypoimmunogenic and safe harbor engineered IPSC derived cells. The agreement enables Bone Therapeutics to access, evaluate and materially transfer Implant Therapeutics Induced Pluripotent Stem Cell (iPSC) derived, genetically engineered MSCs, including lines, media, differentiation protocols and expertise.

In November 2021, Bone Therapeutics signed a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics allogeneic osteoblastic cell therapy product, with one of its current Chinese partners, Link Health Pharma Co., Ltd (Link Health). The negotiations for the global rights agreement are still ongoing but take longer than expected. The envisaged completion of a final binding agreement has been delayed and is now contemplated over the course of Q2 2022.

Corporate highlights (including post-period events)

In March, 2021, Bone Therapeutics appointed the stem cell therapy industry veteran, Anthony Ting, PhD, as Chief Scientific Officer. Dr. Ting is responsible for Bone Therapeutics research activities.

In July 2021, Bone Therapeutics appointed Dr. Anne Leselbaum as Chief Medical Officer. Dr. Leselbaum brings three decades of experience in strategic international clinical development, clinical operations and medical affairs. As CMO, she takes responsibility for the leadership of all clinical development and medical affairs strategies and activities across the entire Bone Therapeutics pipeline and will oversee the regulatory interactions.

In September 2021, Bone Therapeutics appointed Lieve Creten, as interim Chief Financial Officer (CFO), succeeding Jean-Luc Vandebroek. Lieves extensive financial experience ensures the continued optimal financial control, oversight and compliance.

In October 2021, Bone Therapeutics appointed key experts to its Scientific Advisory Board (SAB). The members of the SAB consist of world-recognized scientists and clinicians in the cell and gene therapy field.

In March 2022, Bone Therapeutics announced it was redefining its strategic priorities to concentrate specifically on the development of its most advanced clinical asset, ALLOB. As a result, Bone Therapeutics will focus its R&D activities to support the clinical development of ALLOB and all activities related to the development of the pre-clinical iMSCg platform as well as all other non ALLOB related activities, were stopped. In this context, some members of Bone Therapeutics' management team will depart Bone Therapeutics in the following months in alignment with the refocus in activity. This includes Miguel Forte (CEO), Tony Ting (CSO), Stefanos Theoharis (CBO) and Lieve Creten (CFO). During the transition, CEO, Miguel Forte, will remain in function. The Scientific Advisory Board was also dissolved.

Financial highlights (including post-period events)

In July 2021, Bone Therapeutics secured a loan agreement of up to 16.0 million with the European Investment Bank (EIB). The EIB loan financing will be disbursed in two tranches of 8.0 million each, subject to conditions precedent. Following the approval of the issuance of associated warrants by Bone Therapeutics General Meetings at the end of August 2021, Bone Therapeutics received a payment from the EIB for the first tranche of 8.0 million and the EIB was granted 800,000 warrants approved by the Extraordinary General Meeting.

In August 2021, Bone Therapeutics also renegotiated 800 convertible bonds issued on May 7, 2020 (for an amount of 2 million) to Patronale Life into a loan subject to the same repayment terms as the agreement with the EIB, with the issuance of 200,000 additional warrants approved by the Extraordinary General Meeting.

In December 2021, Bone Therapeutics raised additional 3.3 million funding through a private placement with current and new institutional investors to advance its lead orthopedic asset, ALLOB, through mid-stage clinical development.

The total revenues and operating income for 2021 amounted to 2.7 million compared to 3.7 million in 2020. As a result of the reduced clinical activities following the completion of the Phase III JTA-004 study, and the slower pace of patient enrollment for the ALLOB TF2 Phase IIb study due to the COVID-19 pandemic, operating loss for the period decreased to 12.0 million from 15.0 million for the full year 2020. Consequently, cash used for operating activities amounted to 12.8 million for the full year 2021. Year-end cash position amount to 9.5 million compared to 14.7 million year-end 2020.

In April 2022, Bone Therapeutics signed a binding term sheet for a 5 million convertible bonds (CBs) facility arranged by ABO Securities. The proceeds of the financing will be used to advance the clinical development of Bone Therapeutics lead asset, the allogeneic bone cell therapy, ALLOB. ABO Securities, on behalf of the CB investor, commits to subscribe to up to 5 million in CBs. Subject to the fulfillment of condition precedents, Bone Therapeutics and ABO Securities aim to agree on and execute the final subscription agreement for the CBs and to issue the first tranche of CBs by the beginning of May 2022.

Outlook for the remainder of 2022

In the ongoing Phase IIb ALLOB clinical study in difficult tibial fractures, Bone Therapeutics clinical team, in partnership with its clinical research organization, is continuing to institute measures to mitigate the impact of the pandemic and will closely monitor the recruitment progress. As a result of the initial mitigation actions and the improving recruitment rate due to the gradual lifting of COVID-19 related measures in Europe, Bone Therapeutics expects to report topline results as scheduled by the first quarter of 2023. However, a delay cannot be excluded. Should the pandemic continue to have impact on patient availability, Bone Therapeutics may have to re-evaluate this timeline and, in that eventuality, will communicate again to the market.

The negotiations for ALLOB, with one of Bone Therapeutics current Chinese partners, for the global rights agreement are still ongoing but are taking longer than originally anticipated. The potential completion of a final binding agreement has been delayed into Q2 2022.

Subsequent to some preliminary contacts, the board of directors of Bone Therapeutics is currently examining various opportunities to combine certain activities within Bone Therapeutics, taking into account the interests of its shareholders and other stakeholders. Further announcements will be made in due course, if and when circumstances so allow or require.

Following the restructuring of the management team announced on 12 April 2022, Bone Therapeutics has initiated the search for a new CEO and CFO.

Disciplined cost and cash management will remain a key priority. The operating cash burn for the full year 2022 is expected to be in the range of 8-10 million, assuming normal operations as the effect of the ongoing COVID-19 epidemic cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into Q1 2023, assuming, amongst other, full issuance of the new convertible bond facility. Bone Therapeutics refers to the going concern statement in the Annual Report 2021 for all key assumptions taken.

Conference call

Miguel Forte, MD, PhD, Chief Executive Officer will host a webcast with conference call today at 3:00 pm CEST / 9:00am EST. To participate in webcast or the conference call, please use the following link:

https://us06web.zoom.us/j/81633950602

Or select your dial-in number from the list below quoting the conference ID 816 3395 0602#:

Belgium: +32 2 290 9360France: +33 1 7095 0103United Kingdom: +44 208 080 6592United States: +1 646 876 9923

The presentation will be made available on the Investors section - Presentations of the Bone Therapeutics website shortly prior to the call.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. Currently Bone Therapeutics is concentrating specifically on the development of its most advanced clinical asset, the allogeneic cell therapy platform, ALLOB.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Its leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerLieve Creten, Chief Financial Officer ad interimTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicBert BouserieTel: +32 (0)488 40 44 77bert.bouserie@bepublicgroup.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Excerpt from:
Bone Therapeutics announces 2021 full year results - GlobeNewswire

Bone Marrow Stem Cells Comments Off on Bone Therapeutics announces 2021 full year results – GlobeNewswire | April 29th, 2022

Early outcomes with the combination of JSP191, fludarabine, and low-dose total body radiation (TBI) demonstrated facilitation of full donor myeloid chimerism, clearing of minimal residual disease (MRD), and a well-tolerated safety profile in older patients with myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) receiving non-myeloablative (NMA) allogenic hematopoietic cell transplantation (AHCT).

Results from the phase 1 trial (NCT04429191) presented at the 2022 Transplantation & Cellular Therapy Meetings, showed there were no infusion toxicities or serious adverse events with JSP191, and no instances of primary graft failure in first 24 patients enrolled on the trial; only 1 patient had secondary graft failure and went on to have successful retransplant. Additionally, MRD clearance was observed in 12 patients, and JSP191 pharmacokinetics were shown to be predictable.

AHCT is the only curative treatment for many patients with MDS/AML, even though there have been advancements in therapy for these patients in recent years. While transplant has proven feasible for adults well into their 70s, the optimal conditioning regimen for older adults remains unknown as more intensive regimens tend to be associated with transplant-related mortality, while less intensive nonmyeloablative regimens have resulted historically in higher rates of disease relapse and progression, Lori Muffly, MD, MS, said in her presentation.

Therefore, a conditioning regimen that results in minimal toxicity but has enhanced disease control is needed in order to improve transplantation outcomes in this population, Muffly, associate professor of medicine (blood and marrow transplantation and cellular therapy) at Stanford Healthcare, continued.

JSP191 is a humanized monoclonal antibody meant to block stem cell factor binding site on CD117, which is necessary for hematopoietic stem cell (HSC) survival and HSC interactions in the bone marrow niche. After the bone marrow niche is emptied because of JSP191 binding to CD117, healthy donor cells are able to engraft. Preclinical models showed synergy between anti-CD117 monoclonal antibodies and low-dose TBI to help deplete HSC and facilitate donor cell engraftment.

For the first 24 patients with MDS (n = 13) or AML (n = 11), primary end points evaluated were safety, tolerability, and pharmacokinetics of the combination. Secondary end points included engraftment and donor chimerism, MRD clearance, relapse-free survival, graft-vs-host disease (GVHD), non-relapse mortality, and overall survival. Patients received AHCT, then 200 to 300 cGy of TBI, 30 mg/m2 of fludarabine for 3 days, and 0.6 mg/kg of intravenous JSP191.

To determine the starting date of fludarabine, real-time pharmacokinetic measurements and modeling were used after JSP191 was administered. For the first 7 patients, TBI was increased from 200 to 300 cGy to aid lymphoablation. Tacrolimus, sirolimus, and mycohphenolate motefil were used as GVHD prophylaxis.

Consistent pharmacokinetics and predictable clearance were observed with JSP191 over the 2 weeks after administration. All patients were able to receive donor cell infusion between 9 and 15 days following administration of the antibody. Interestingly, we did see in some patients very low levels of the antibody present on the day of donor cell infusion, and this did not appear to impact donor cell engraftment, Muffly said.

Bone marrow aspirations taken at screening and between administration of the antibody and fludarabine/TBI showed JSP191 depletes hemopoietic stem and progenitor cells (HSPC). In the CD34-positive, CD45RA-negative population, there was a 66% mean depletion of HSPC. The investigators do not believe this reflects the nadir of HSPC depletion, Muffly explained, and that the depletion continues until donor stem cell infusion.

All patients experienced neutropenia followed by neutrophil engraftment between TD+15 and TD+26. Primary engraftment was seen in all patients, with only 1 patient losing myeloid chimerism early, which was associated with disease progression. T cell chimerism improved when patients went up from 200 to 300 cGy.

Using flow cytometry, cytogenetics, and next-generation sequencing, investigators were able to track MRD in patients with de novo AML (n = 8) and AML from MDS (n = 3). Of the 9 patients with AML who were MRD positive at the time of enrollment, 6 were MRD negative at the time of follow-up. Eleven of 13 patients with MDS were MRD positive at enrollment, and 8 were MRD negative at the last follow-up.

After 6 months median follow-up (range, 2-12 months), there were no reports of classical grade II-IV acute GVHD. One case of late onset grade III-IV acute gastrointestinal GVHD was reported as of the latest follow-up, but this patient had non-relapse mortality. Any instances of chronic GVHD has yet to be reported due to insufficient median follow-up time. Morphologic relapse occurred in 4 patients, 3 with AML and 1 with MDS.

The median age for these patients was 70 years (range, 62-79), with a requirement of 60 years of age or older or an AHCT-comorbidity index of 3 or more to enroll in the trial. They could not have prior AHCT and needed a human leukocyte antigenmatched related or unrelated donor. Over half of patients received only a hypomethylating agent-containing regimens.

JSP191 in combination with fludarabine and low-dose TBI is a novel conditioning platform that appears safe, well tolerated, has demonstrated on-target effects of HSPC depletion, permits full donor myeloid chimerism, and results in promising early MRD clearance, Muffly concluded.

Reference:

Muffly L, Lee CJ, Gandhi A, et al. Preliminary data from a phase 1 study of JSP191, an anti-CD117 monoclonal antibody, in combination with low dose irradiation and fludarabine conditioning is well-tolerated, facilitates chimerism and clearance of minimal residual disease in older adults with MDS/AML undergoing allogeneic HCT. Presented at: 2022 Transplantation & Cellular Therapy Meetings; Salt Lake City, UT; April 23-26, 2022. Abstract LBA4. https://bit.ly/3xRTwee

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Interim Data Targeting CD117 Show Promising MRD Results and Safety in MDS/AML - Targeted Oncology

Bone Marrow Stem Cells Comments Off on Interim Data Targeting CD117 Show Promising MRD Results and Safety in MDS/AML – Targeted Oncology | April 29th, 2022

Hairy cell leukemia is a rare type of blood cancer that can affect adults. In people who receive treatment, the long-term outlook for hairy cell leukemia is good.

Hairy cell leukemia (HCL) occurs when bone marrow produces too many white blood cells called lymphocytes.

The disease gets its name from the hairlike projections on its cells. HCL cells can affect the bone marrow, spleen, liver, and lymph nodes.

According to the National Organization for Rare Disorders, HCL is more common in males over the age of 50 years.

HCL affects roughly 6,000 people in the United States, with around 600800 new diagnoses each year. Around 12% of all adult leukemias are HCL.

In many cases, the long-term outlook for HCL is good, with people often continuing to live good-quality lives for years with medical care.

In this article, we look at the outlook and survival rates for HCL, the risk of secondary cancers, and treatment options.

Learn about the symptoms of HCL here.

HCL is a chronic disease, and although there is no cure for it, the condition is treatable. Treatment is usually highly effective and can help people continue to live normal lives.

According to the National Cancer Institute, HCL progresses slowly or does not worsen at all.

The Leukemia and Lymphoma Society reports that the 5-year event-free survival rate for HCL is 90% in people who received initial treatment with the chemotherapy drug cladribine. This means 90% of people will still be alive 5 years after diagnosis.

Treatment with cladribine has led to roughly 85% complete remission and around 10% partial response in people with HCL.

A 2020 study looked at survival rates in 279 people diagnosed with HCL between 1980 and 2011. The median age of the participants was 59 years old. In 208 of the participants, the first-line treatments were the drugs cladribine or pentostatin.

A 10-year follow-up found that the median survival rate was 27 years overall, with 11 years of relapse-free survival. There was a relapse rate of 39%. The study concluded that people with HCL have a good long-term outlook.

Research suggests that there may be racial disparities in HCL outcomes. A 2015 study included participants of the following racial groups:

The study found that the 10-year survival rate was worse in African American participants than in those of other racial groups.

Half of African American participants were alive at the 10-year follow-up, whereas more than two-thirds of those in other racial groups were alive at the follow-up.

The researchers concluded that the biological, socioeconomic, and health system factors contributing to this disparity need further investigation.

According to a 2020 study, people with HCL have an increased risk of secondary cancer.

Among 279 participants, 59 people developed at least one secondary cancer. The most common secondary cancers were prostate cancer, nonmelanoma skin cancer, and blood cancers.

The study did not find that treatment with purine analogs, such as cladribine or pentostatin, was a risk factor for secondary cancers.

However, according to the National Cancer Institute, cladribine and pentostatin may increase the risk of Hodgkin lymphoma and non-Hodgkin lymphoma.

Some research suggests that HCL and its effects on the body may increase the risk of secondary cancer.

People with HCL must attend regular cancer screenings to detect any early signs of secondary cancer.

Blood cell changes in those with HCL may result in compromised immune systems, making people more susceptible to infection or autoimmune disease.

HCL responds very well to treatment, which aims to manage the cancer rather than cure it.

Unlike with many other types of cancer, doctors may choose to wait before starting treatment.

Doctors will monitor the condition and may only begin treatment if they believe it is necessary to control it. This can help avoid any unnecessary side effects of treatment.

The type of treatment will depend on each condition but may include the following:

Cladribine and pentostatin are purine analogs, which are the first-line treatment for HCL.

According to the Hairy Cell Leukemia Foundation, both medications are highly effective treatments and can result in long-term remission.

In 2018, the Food and Drug Administration (FDA) approved another drug, moxetumomab pasudotox, to treat HCL. Doctors may use this drug in people who have not responded to standard therapies.

Interferon is a drug that doctors may use to treat HCL. Interferon uses the bodys immune system to help fight off cancer. Interferon affects how cancer cells divide and helps slow tumor growth.

Doctors may also use a biologic drug called rituximab, known by the brand name Rituxan, if people with HCL have not responded to other treatments. Rituximab is an antibody that attaches to HCL cells. Doctors may also use rituximab in combination with chemotherapy as a first-line treatment.

Targeted therapies use medications or other substances to find and destroy cancer cells. Targeted therapies may cause less harm to healthy cells than other treatments, such as radiation therapy or chemotherapy.

One type of targeted therapy to treat HCL is monoclonal antibody therapy. A laboratory creates antibodies that attach to cancer cells and destroy them or prevent them from growing and spreading. The biologic drug rituximab is an example of a monoclonal antibody.

Splenectomy is a surgical procedure to remove the spleen. This may be necessary if HCL causes an enlarged spleen.

However, doctors rarely perform splenectomy for HCL because there are medications that can effectively reduce the size of the spleen.

Learn more about immunotherapy for leukemia here.

Treatments for HCL can have the following side effects:

Cancer treatments may also cause other side effects, such as fatigue, appetite loss, or nausea.

Before starting treatment, people can discuss any potential side effects and the risks and benefits of each treatment option with their healthcare team.

Learn more about side effects here.

HCL is a rare type of leukemia. Other types of leukemia include:

HCL is a rare type of adult leukemia. It is more common in males over the age of 50 years.

The overall outlook for people with HCL is good. Treatment with chemotherapy drugs, such as cladribine and pentostatin, is highly effective and may result in long-term remission.

Treatments for HCL may have side effects. People can discuss any treatments potential risks and benefits with their healthcare team.

More here:
Hairy cell leukemia: Outlook, treatment, and what to expect - Medical News Today

Bone Marrow Stem Cells Comments Off on Hairy cell leukemia: Outlook, treatment, and what to expect – Medical News Today | April 29th, 2022

Abstract: Glucose metabolism has been the focus of research in order to understand pathological conditions associated with diseases such as neonatal hypoxic-ischemic-encephalopathy (HIE), cerebral palsy (CP) and cerebral infarction.

Objective:To evaluate the use of molecular imaging (SPECT and PET) for children with HIE and CP before and after cell therapy, and to propose future perspectives on the use of those modalities for assessment of brain function in children with these conditions.

Methods:PubMed search for studies using PET or SPECT scans for HIE and CP in children.

Results:We identified 18 PET and 17 SPECT studies that have been performed in cases under age of 19 over the past three decades (19912021). Six papers on PET use consisted of one with human umbilical cord derived mesenchymal stromal cells, one mobilized peripheral blood mononuclear cells, three autologous bone marrow mononuclear cells and one allogeneic umbilical cord blood. 4/6 papers reported that PET-CT scan revealed increased glucose metabolism and 1/6 showed no significant change in glucose metabolism after cell therapy. One article on SPECT reported that 2/5 cases had improvement of cerebral perfusion in the thalamus after treatment.

Discussion:SPECT in the first few weeks of life is useful and more sensitive than MRI in predicting major neurological disability. SPECT is not appropriate for neonates because of the risk of radiation, improvement of other clinical test equipment. PET studies reported high glucose metabolism in the early neonatal periods in children with mild to moderate HIE, but not in the most severe cases, including those neonates that died.We suggested that PET could be more useful tool to estimate effectiveness of stem cell therapy than SPECT.

Conclusion:PET might be a good clinical modalities to clarify mechanism of stem cell therapy for CP. We need further clinical studies to clarify more precisely.

Read more:
Molecular Imaging (PET and SPECT) for Children with Hypoxic-ischemic-encephalopathy and Cerebral Palsy before and after cell therapy - Newswise

Bone Marrow Stem Cells Comments Off on Molecular Imaging (PET and SPECT) for Children with Hypoxic-ischemic-encephalopathy and Cerebral Palsy before and after cell therapy – Newswise | April 29th, 2022

Abstract

Arrhythmias are a major cardiac complication reported among patients with multiple myeloma (MM), but these have not been further characterized in this population. We explored the prevalence of arrhythmias and examined the predictors of mortality among patients with MM with arrhythmias. The National Inpatient Sample data collected between 2016 and 2018 were used to conduct retrospective analyses. Multivariable logistic regression analyses were done to examine the predictors of mortality among patients with MM with arrhythmias. 16.9% of patients with MM reported a diagnosis of any arrhythmias and 70.7% of these were atrial fibrillation. Patients aged 70 years and above had 21% lower odds (adjusted OR (AOR): 0.79; 95% CI: 0.68 to 0.92) of inpatient mortality relative to younger patients. Those in the non-Hispanic black, Hispanic, and non-Hispanic other category were 1.38 (95% CI: 1.16 to 1.64), 1.53 (95% CI: 1.19 to 1.97), and 1.69 (95% CI: 1.29 to 2.21) times more likely to die during hospitalization compared with their counterparts who were non-Hispanic whites. Relative to patients with MM who were on Medicare, those on private (AOR: 1.28; 95% CI: 1.06 to 1.54) and other insurance types (AOR: 1.78; 95% CI: 1.23 to 2.58) had higher odds of mortality. Other predictors of inpatient mortality were elective admission (AOR: 0.67; 95% CI: 0.52 to 0.85) and Charlson comorbidity indices between 57 (AOR: 1.23; 95% CI: 1.07 to 1.41) and 8 (AOR: 1.45; 95% CI: 1.21 to 1.73) compared with comorbidity indices between 0 and 4. Our study adds to the body of knowledge on the need for proper diagnosis and management of cardiac arrhythmias in patients with MM. Research is needed to further assess the time of arrhythmia diagnosis and its impact on health outcomes among patients with MM.

See the article here:
Burden of arrhythmias and predictors of mortality among multiple myeloma patients with arrhythmias - Journal of Investigative Medicine

Bone Marrow Stem Cells Comments Off on Burden of arrhythmias and predictors of mortality among multiple myeloma patients with arrhythmias – Journal of Investigative Medicine | April 29th, 2022

NEW YORK, April 28, 2022 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today announced that management will host a webcast and conference call to provide a business update at 4:30 P.M. ET on Thursday, May 5th, 2022. Participating on the call will be Dr. Phil Gomez, Chief Executive Officer, Daniel Luckshire, Chief Financial Officer, and Dennis Hruby, Chief Scientific Officer.

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SIGA Technologies to Host Business Update Call on May 5th, 2022 Following Release of First Quarter 2022 Financial Results

Global News Feed Comments Off on SIGA Technologies to Host Business Update Call on May 5th, 2022 Following Release of First Quarter 2022 Financial Results | April 29th, 2022

SALT LAKE CITY, April 28, 2022 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, will hold its first-quarter 2022 earnings conference call on Thursday, May 5, 2022 at 4:30 p.m. EDT. The company’s quarterly earnings will be released the same day prior to the market opening.

Excerpt from:
Myriad Genetics to Release First-Quarter 2022 Financial Results on May 5, 2022

Global News Feed Comments Off on Myriad Genetics to Release First-Quarter 2022 Financial Results on May 5, 2022 | April 29th, 2022

REDWOOD CITY, Calif., April 28, 2022 (GLOBE NEWSWIRE) -- Seer, Inc. (Nasdaq: SEER), a life sciences company commercializing a disruptive new platform for proteomics, today announced that the company will be participating in the upcoming BofA Securities 2022 Healthcare Conference in Las Vegas, Nevada.

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Seer to Present at the BofA Securities 2022 Healthcare Conference

Global News Feed Comments Off on Seer to Present at the BofA Securities 2022 Healthcare Conference | April 29th, 2022

SAN DIEGO, April 28, 2022 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, today announced that Histogen’s financial results for the first quarter ended March 31, 2022 will be released after the close of market on Thursday, May 12, 2022.

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Histogen to Report First Quarter 2022 Financial Results and Provide Business Update

Global News Feed Comments Off on Histogen to Report First Quarter 2022 Financial Results and Provide Business Update | April 29th, 2022

CAMBRIDGE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, plans to report first quarter 2022 financial results and corporate highlights after the close of market on Thursday, May 5, 2022. The company will not be conducting a teleconference in conjunction with its financial results press release.

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Relay Therapeutics to Announce First Quarter 2022 Financial Results and Corporate Highlights

Global News Feed Comments Off on Relay Therapeutics to Announce First Quarter 2022 Financial Results and Corporate Highlights | April 29th, 2022

FREMONT, Calif., April 28, 2022 (GLOBE NEWSWIRE) -- Cytek Biosciences, Inc. (“Cytek Biosciences” or “Cytek”) (Nasdaq: CTKB), today announced it will report financial results for the first quarter 2022 after market close on Wednesday, May 11th, 2022. The company’s management will webcast a corresponding conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its results, business developments and outlook.

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Cytek Biosciences to Report First Quarter Financial Results on May 11, 2022

Global News Feed Comments Off on Cytek Biosciences to Report First Quarter Financial Results on May 11, 2022 | April 29th, 2022

ERYTECH Announces Filing of 2021 Universal Registration Document and 2021 Annual Report on Form 20-F, as well as its 2022 financial calendar

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ERYTECH Announces Filing of 2021 Universal Registration Document and 2021 Annual Report on Form 20-F, as well as its 2022 financial calendar

Global News Feed Comments Off on ERYTECH Announces Filing of 2021 Universal Registration Document and 2021 Annual Report on Form 20-F, as well as its 2022 financial calendar | April 29th, 2022

CAMBRIDGE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that it has initiated a process to explore a range of strategic alternatives to maximize shareholder value and has engaged professional advisors, including an investment bank to act as a strategic advisor for this process. Strategic alternatives that will be evaluated include the sale of all or part of the Company, merger or reverse merger.

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Genocea Initiates Restructuring and Announces Plan to Explore Strategic Alternatives

Global News Feed Comments Off on Genocea Initiates Restructuring and Announces Plan to Explore Strategic Alternatives | April 29th, 2022

SAN DIEGO, April 28, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced it will report first quarter 2022 financial results on Thursday, May 5, 2022, after the close of the U.S. financial markets. The Company will host a conference call and webcast to discuss the financial results and provide a general business update at 4:30 p.m. ET.

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Travere Therapeutics to Report First Quarter 2022 Financial Results

Global News Feed Comments Off on Travere Therapeutics to Report First Quarter 2022 Financial Results | April 29th, 2022

PHILADELPHIA and OXFORDSHIRE, United Kingdom, April 28, 2022 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will report financial results and provide business updates for the first quarter ended March 31, 2022, before the US markets open on Monday, May 9, 2022. Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) that same day.

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Adaptimmune to Report Q1 2022 Financial Results and Business Updates on Monday, May 9, 2022

Global News Feed Comments Off on Adaptimmune to Report Q1 2022 Financial Results and Business Updates on Monday, May 9, 2022 | April 29th, 2022

WOODCLIFF LAKE, N.J., April 28, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX) today announced that the Company will release its 2022 first quarter financial results on Monday, May 9, 2022, before the market opens.

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Eagle Pharmaceuticals to Host First Quarter 2022 Financial Results on May 9, 2022

Global News Feed Comments Off on Eagle Pharmaceuticals to Host First Quarter 2022 Financial Results on May 9, 2022 | April 29th, 2022

JUPITER, Fla., April 28, 2022 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (“Dyadic”, “we”, “us”, “our”, or the “Company”) (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced that it will report its financial results for the first quarter 2022 and host a corporate update conference call on Thursday, May 12, 2022.

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Dyadic to Report First Quarter 2022 Financial Results on Thursday, May 12, 2022

Global News Feed Comments Off on Dyadic to Report First Quarter 2022 Financial Results on Thursday, May 12, 2022 | April 29th, 2022

SAN DIEGO, April 28, 2022 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that it will report first quarter 2022 financial results after the U.S. financial markets close on Thursday, May 5, 2022. Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to provide a comprehensive business update and discuss the Company’s financial results.

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Oncternal Therapeutics to Provide Business Update and Report First Quarter 2022 Financial Results

Global News Feed Comments Off on Oncternal Therapeutics to Provide Business Update and Report First Quarter 2022 Financial Results | April 29th, 2022

Company to hold conference call on May 12th at 8:30 am EDT Company to hold conference call on May 12th at 8:30 am EDT

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Aadi Bioscience to Announce First Quarter 2022 Financial Results on May 12, 2022

Global News Feed Comments Off on Aadi Bioscience to Announce First Quarter 2022 Financial Results on May 12, 2022 | April 29th, 2022

SOMERVILLE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.

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Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND

Global News Feed Comments Off on Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND | April 29th, 2022