On June 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that data from a pre-clinical study with next-generation ONCOS-200 series viruses with novel anti-cancer double-transgenes was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting (Press release, Targovax, JUN 24, 2020, View Source [SID1234564005]).

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The pre-clinical in vitro and in vivo findings demonstrated that both ONCOS-210 & ONCOS-212 have anti-cancer properties and that the double transgenes act synergistically. The encouraging preclinical findings will be further investigated to elucidate transgene functionality and mode of action.

See poster here: Next generation ONCOS oncolytic adenovirus with novel anti-cancer double-transgenes shows synergistic anti-cancer effect in a melanoma mouse model.

On June 24, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported a change to the presentation time of the Company’s oral virtual presentation at the upcoming Next Gen Immuno-Oncology Congress (Press release, BerGenBio, JUN 24, 2020, View Source [SID1234561435]). Updated details are as follows:

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Date and time: 25 June 2020, 12.00 noon EST (6.00 pm CET)

Title: Targeting AXL to leverage checkpoint immunotherapy: ​Updated results of the BGBC008 phase II study of bemcentinib and pembrolizumab in recurrent NSCLC

Session name: Targeted Antibodies and Cellular Therapy

The presentation to be given by Prof. Hani Gabra MD PhD, CMO BerGenBio, will provide an update of results from a phase II trial (BGBC008), evaluating bemcentinib in combination with MSD’s Keytruda (pembrolizumab) in previously treated non-small cell lung cancer (NSCLC) patients with confirmed progression, including positive top line clinical and translational data from stage 1 of Cohort B in patients having failed prior immune checkpoint therapy.

The presentation will be available on the Company website in the Presentations section on 25 June: www.bergenbio.com/investors/presentations/

– END –

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On June 24, 2020 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported it has completed patient enrollment in its Phase 3 DOM-INNATE ("Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity") study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients (Press release, Soligenix, JUN 24, 2020, View Source [SID1234561454]). The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee (DMC). With enrollment completed, top-line results are expected in the fourth quarter of 2020.

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SGX942 is a novel, first-in-class, Innate Defense Regulator (IDR) which both modulates inflammation and enhances anti-infective and tissue-healing pathways of the innate immune system. Study enrollment was temporarily extended as Soligenix assessed the potential impact of COVID-19 on the study (e.g., patient treatment compliance and completion of necessary assessments). With extra efforts by participating patients, physicians and clinical staff, the Company can now successfully report that the negative impact of the pandemic on the overall study was much less than initially anticipated. The study remains on-track to provide top-line results before the end of 2020.

"We are pleased to have completed enrollment and look forward to the top-line results in the fourth quarter, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We continue to positively position this fast-tracked program for approval. With approximately $8 million in cash as of the end of the first quarter, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in the DOM-INNATE study. As there is no FDA approved drug for the treatment of oral mucositis in head and neck cancer or other solid tumor settings, we believe SGX942 has the potential to be the first approved therapy to address this unmet medical need and dramatically improve the lives of patients undergoing chemoradiation therapy (CRT)."

"SGX942 has the potential to have a significant impact on the lives of patients undergoing CRT for squamous cell carcinoma of the oral cavity and oropharynx," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "We would like to thank the DMC members, our esteemed medical advisory board and our dedicated clinical investigators for their efforts in the design and conduct of this important clinical trial, as well as all the subjects that are participating in the trial. Our focus now is to complete the treatments for all subjects in both the US and Europe and to lock the study database, facilitating top-line results in the fourth quarter of 2020."

Based on the positive results demonstrated in the Phase 2 study of SGX942, the Phase 3 trial is a highly powered, double-blind, randomized, placebo-controlled, multicenter and multinational trial. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. Other secondary measures, including incidence of severe oral mucositis, incidence and duration of ulcerative oral mucositis, and incidence of infection will also be assessed at topline or during the 12-month follow-up.

A prospectively defined interim analysis was conducted in August 2019 by an independent DMC and was used to verify the underlying assumptions defining the required sample size of the study to maintain its rigorous 90% statistical power. The DMC identified a beneficial SGX942 effect and accordingly adjusted the study sample size to approximately 260. The DMC did not identify any safety concerns. The interim recommendation is described in the August 2019 press release here.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

In the pediatric population, head and neck cancer is a rarer occurrence and is caused by different underlying pathologies. The major types of HNC in children are lymphoma, sarcomas (including rhabdomyosarcomas), and neuroblastoma rather than squamous cell carcinoma, the major type of adult HNC cancers. Hematopoietic stem cell transplantation (HSCT), especially allogeneic transplantation with higher risk of oral mucositis, is more frequently used in the pediatric population than in adults when treating a number of primary tumor types, as seen in leukemia and lymphoma. Both treatment of HNC and HSCT are associated with high risk of oral mucositis in the pediatric population.

Oral mucositis remains an area of unmet medical need where there are currently no approved drug therapies in the context of any solid tissue tumors.

About the Phase 3 DOM-INNATE Study

This multinational, placebo-controlled, randomized study is targeted to enroll approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects are randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of severe oral mucositis, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects are to be followed for an additional 12 months after the completion of treatment. Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study.

About Dusquetide

Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body’s reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host’s innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis.

SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC. Soligenix is working with leading oncology centers in the US and Europe to advance SGX942 in oral mucositis with the conduct of a pivotal Phase 3 clinical trial referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity).

SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.

Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.

In addition, a high level review of the IDR technology platform is available here.

On June 24, 2020 Relay Therapeutics, a Phase 1 biotech developing small molecule therapies for solid tumors, reported that filed with the SEC to raise up to $200 million in an initial public offering (Press release, Relay Therapeutics, JUN 24, 2020, View Source [SID1234561437]).

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The company’s lead candidate RLY-1971, an inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2), began a Phase 1 trial in patients with advanced solid tumors in the 1Q 2020. Relay is also planning to begin a Phase 1 trial of RLY-4008, an oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in patients with advanced solid tumors having oncogenic FGFR2 alterations in the 2H 2020.

The Cambridge, MA-based company was founded in 2015 and plans to list on the Nasdaq under the symbol RLAY. J.P. Morgan, Goldman Sachs, Cowen and Guggenheim Securities are the joint bookrunners on the deal. No pricing terms were disclosed.

On June 24, 2020 Diamyd Medical AB (publ) reported that Quarterly Report III 19/20 -September 2019 – May 2020, Fiscal year 2019/2020 (Press release, Diamyd Medical, JUN 24, 2020, View Source;september-2019—may-2020-fiscal-year-20192020-301082638.html [SID1234561455]).

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Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

Further information is available on View Source

Figures in parentheses relate to the corresponding period previous financial year.

September 1, 2019 – May 31, 2020

Net result: MSEK 23.2 (-26.8), whereof third quarter MSEK -7.2 (-7.9). The increase compared to previous year is a one-off effect due to a payment of corresponding MSEK 48.0 from the previous GAD65 manufacturer as support for transition of the manufacturing process.
Result per share: SEK 0.3 (-0.4), third quarter SEK -0.1 (-0.1)
Cash flow from operating activities: MSEK 24.1 (-28.5), third quarter: MSEK -6.8 (-9.1)
Cash and cash equivalents at May 31, 2020: MSEK 81.5 (70.5)
Significant events third quarter, March – May 2020

DiAPREV-IT2: Results presented from clinical trial with Diamyd in children at high risk for type 1 diabetes
Diamyd Medical fully subscribes to its pro rata share in NextCell Pharma’s rights issue
ReGenerate-1: Promising findings from the first part of a clinical trial with Remygen
The European and Japanese Patent Offices granted patents for administration of the diabetes vaccine into the lymph node
Diamyd Medical opened up for vaccine manufacturing in Umeå, Sweden
GADinLADA: New trial with Diamyd in autoimmune diabetes started recruiting patients in Norway
Comments by CEO Ulf Hannelius

We are currently looking forward to the topline results from our ongoing Phase IIb trial DIAGNODE-2. In this innovative trial, the diabetes vaccine Diamyd is administered into a superficial lymph node. This novel administration route enhances the immunological effect of the vaccine by directly targeting the immunological site of action, and results from the pilot trial DIAGNODE-1 support superior clinical efficacy compared to the subcutaneous route used in previous trials.

Notably, we already know that a genetically defined subgroup of type 1 diabetes, a so-called disease endotype, has a very high likelihood of clinically responding to our diabetes vaccine Diamyd when administered subcutaneously. This finding, released in December 2019, is based on a meta-analysis comprising of data from more than 500 patients treated with subcutaneous injections of Diamyd in three previous placebo controlled randomized clinical trials.

Importantly, Battaglia et al. in the publication "Introducing the Endotype Concept to Address the Challenge of Disease Heterogeneity in Type 1 Diabetes, Diabetes Care, Jan 2020", co-authored by 17 of the world’s most prominent key opinion leaders in the field, highlighted the existence of two disease endotypes of type 1 diabetes. These two endotypes were defined by the underlying autoimmunity associated with certain genotypes which is in line with our own findings described above regarding genetically defined subgroups.

There is consequently a strong and emerging case for precision medicine for type 1 diabetes where the aim is to zero in on the actual disease mechanism to tailor treatments for individual patients that are predicted to respond to the therapy. Precision medicine has already shown significant success in the oncology field where certain immunotherapeutic agents, most notably pembrolizumab (KEYTRUDA), target tumors that express specific biomarkers. It remains to be seen if the intralymphatic injections used in DIAGNODE-2 has the potential to work in a more broadly defined group of individuals with type 1 diabetes compared to subcutaneous injections, or if the upcoming results will also support the genetically defined responder subgroup.

To answer this question, the topline results from DIAGNODE-2 will comprise both the primary clinical endpoint and the most important secondary clinical endpoints, as well as the results for the genetically defined subgroups. These results will have an impact on the final design of any upcoming late stage development trials, including the patient population that we will target for the drug label.

This spring we also announced patent approvals in Europe and Japan for intralymphatic administration of Diamyd. The approval provides patent protection in these important pharmaceutical markets until 2035 and complements our US patent protection for the therapeutic use of GAD that is valid until 2032. Patent application for intralymphatic administration of Diamyd has also been granted in Australia and Russia, further strengthening our global patent portfolio.

In addition to the scientific, regulatory and operational progress with the diabetes vaccine Diamyd, we could recently release positive preliminary results from the first stage of the clinical trial with the GABA study drug Remygen which is ongoing at Uppsala University Hospital. Besides an improvement in glycemic control, treatment with Remygen surprisingly normalized the response to hypoglycemia in individuals with long term type 1 diabetes. Preventing hypoglycemia is a significant unmet medical need in type 1 diabetes and if these promising results are replicated, we may have an opportunity to broaden the therapeutic platform around GABA. The main stage of the trial is now ongoing where patients will be treated with both low and high dose of Remygen as well as with the combination of Remygen and the GABA receptor modulator Alprazolam.

We recently announced that, to further cement our control of the Diamyd asset, we are setting up our own facility in Umeå Sweden to manufacture GAD, the active component in Diamyd. The 10,000 square feet facility will give us the opportunity to work directly with licensing partners as well as to build and scale our own commercial manufacturing capabilities. Logistically it is also a perfect match since our drug formulator APL resides in the building next door.

Finally, in these COVID-19 times we are all reminded of the importance of strong drug safety profiles. Unlike other drugs being developed for autoimmune diabetes, Diamyd does not downregulate the immune system and therefore does not increase the risk of infections. Our diabetes vaccine has been evaluated without any safety concerns in trials encompassing more than 1,000 individuals, including healthy young children at risk of type 1 diabetes and in patients with recent-onset diabetes. This is a significant advantage going forward in our pursuit to achieve the best possible outcomes for patients with type 1 diabetes.

Stockholm, June 24, 2020

Ulf Hannelius, President and CEO

Two drugs in clinical development

Diamyd and Remygen are drugs in clinical development that focus on the underlying disease mechanisms of diabetes; the dysfunction and loss of insulin-producing beta cells in the pancreas.

Diamyd is an antigen-specific immunotherapy for the treatment of autoimmune diabetes (type 1 diabetes).

Clinical data indicate the potential of the diabetes vaccine Diamyd to halt or stop the autoimmune destruction of insulin-producing beta cells. The effect is achieved by antigen-specific reprogramming of immune cells by administration of low doses of Diamyd in superficial lymph nodes.

By maintaining the endogenous insulin production, Diamyd has the potential to make a significant difference in the daily life of patients as well significantly reduce the complications of type 1 diabetes.

Intralymphatic treatment with Diamyd is now being investigated in a clinical Phase IIb trial (DIAGNODE-2), with the aim of confirming the previously demonstrated clinical effect from a pilot trial in type 1 diabetes patients (DIAGNODE-1).

Remygen is an oral regenerative and immunomodulatory therapy for the treatment of autoimmune- and type 2 diabetes.

By stimulating the growth of insulin-producing cells, Remygen has the potential to reverse the disease progression in autoimmune- and type 2 diabetes.

Remygen is now being investigated in a clinical Phase I/II trial (ReGenerate-1), where clinical efficacy is evaluated with the aim of optimizing treatment ahead of registration-based trials.

Significant events during the third quarter:
Mar 1, 2020 – May 31, 2020

Results from clinical trial with Diamyd in children at high risk for type 1 diabetes

Results from the investigator initiated prevention trial DiAPREV-IT 2, where 26 healthy children at high risk for type 1 diabetes were treated with two subcutaneous injections of Diamyd or placebo, showed that over the course of two years, one individual in the Diamyd arm and two individuals in the placebo arm were diagnosed. No safety concerns were raised, and the safety profile was comparable between the active arm and the placebo arm. Mechanistic studies are still due to be conducted, and data from both DiAPREV-IT 1 and DiAPREV-IT 2 will be evaluated in a combined analysis.

Diamyd Medical fully subscribes to its pro rata share in NextCell Pharma’s rights issue

Diamyd Medical announced that it will invest its pro rata share corresponding to approximately SEK 3.2 million in the associated company NextCell Pharma’s ongoing rights issue, meaning that Diamyd Medical’s book value of the holding in NextCell Pharma after the investment will increase from SEK 8.5 million to approximately SEK 11.7 million.

Promising findings from the first part of a clinical trial with Remygen

The initial safety and dose escalation part of the Phase I/II trial ReGenerate-1 with Remygen in individuals with long-term type 1 diabetes presented preliminary results showing that the trial participants’ blood sugar control improved over the nine-day treatment period. The results also supported a surprising protective effect of Remygen during hypoglycaemia, that is, during sharply lowered blood sugar levels. The findings in the trial are patent pending. The independent Data Safety Monitoring Board (DSMB) has previously approved the commencement of the main part of ReGenerate-1, which among other things evaluates Remygens effect on restoring beta cell function.

The European and Japanese Patent Offices granted patent for intralymphatic administration of the diabetes vaccine Diamyd

The granted patents are valid until 2035 and provides central protection for the diabetes vaccine Diamyd. In particular, the patent protects the intralymphatic administration method that is being evaluated in the Phase IIb trial DIAGNODE-2 and which previously showed positive results in the Phase I/II trial DIAGNODE-1.

Vaccine manufacturing in Umeå

Diamyd Medical announced that a new manufacturing facility is being set up in Umeå by Diamyd Medical. The first priority of the new site is to receive the process technology for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd.

New trial with Diamyd in autoimmune diabetes started recruiting patients in Norway

GADinLADA, the first clinical phase II trial with the diabetes vaccine Diamyd administered directly into the lymph node in patients with LADA started recruitment at the Norwegian University of Science and Technology in Trondheim (NTNU), in cooperation with St. Olav’s University Hospital, Trondheim. The trial will also be conducted in Sweden at the Center for Diabetes, the Academic Specialist Center. In total, the trial encompasses 15 patients between the ages of 30 to 70 years diagnosed with LADA within the last 12 months who are not yet on insulin therapy.

Ongoing clinical trials

Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a drug that improves the prospects for patients with diabetes is of utmost importance. The effect of intralymphatic administration of Diamyd, an antigen-specific immunotherapy aimed at stopping the immune system’s attack on insulin-producing beta cells in autoimmune diabetes, is evaluated in the Phase IIb trial DIAGNODE-2. Remygen, which aims to stimulate the growth of beta cells in patients with diabetes, is now evaluated in patients in a Phase I/II trial.

Trials with Diamyd in lymph node

DIAGNODE -2 – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
A follow-up double-blind randomized clinical trial where Diamyd is administered directly into a lymph node with oral supplements of vitamin D. The trial encompasses 109 patients from Sweden, the Czech Republic, Spain and the Netherlands, aged 12-24 years who have recently been diagnosed with type 1 diabetes and will continue for a total of 15 months. As of autumn 2019, those patients who have not performed their last visit at 15 months are invited to participate in a nine months extension of the trial. 15-month results are expected to be presented in the third quarter of 2020. The aim of the trial is to evaluate the patients’ remaining insulin producing capacity. Coordinating Investigator is Professor Johnny Ludvigsson at Linköping University, Sweden. Diamyd Medical is the Sponsor of the trial.

GADinLADA – DIAMYD IN LYMPH NODES WITH ORAL SUPPLEMENTATION OF VITAMIN D
An open-label, investigator initiated clinical trial where Diamyd is administered directly into a lymph node with oral supplements of vitamin D. The trial encompasses 15 patients aged 30-70 years diagnosed with LADA (Latent Autoimmune Diabetes in Adults) and not yet on inulin treatment. The aim with the trial is to evaluate the safety of intralymphatic treatment with Diamyd in LADA patients and to continuously evaluate the immunological and clinical response during a one-year period. Sponsor of the trial is the Norwegian University of Science and Technology with Ingrid K Hals as sponsor representative.

Trial with Remygen (GABA)

REGENERATE-1 – REMYGEN /ALPRAZOLAM
An open-label, investigator initiated clinical trial with Remygen. The trial includes approximately 36 patients aged 18-50 who have had type 1 diabetes for more than five years with low to non-existing insulin production. The primary aim of the trial is to in a smaller dose escalation section evaluate the safety of Remygen. The main trial also evaluates whether the insulin-producing cells can be regenerated using Remygen, and in the combination of Remygen and Alprazolam. The trial is led by Professor Per-Ola Carlsson at Uppsala University, Sponsor of the trial.