On March 24, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, MAR 24, 2025, View Source [SID1234651366]). The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.

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"We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option."

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

In December 2024, IMNN-001 plus NACT boosted median overall survival to 46 months—outpacing standard-of-care NACT by 13 months—up 2 months from the prior 11-month mark after 7 additional months of follow-up, with an excellent safety profile showing no cytokine release syndrome or serious adverse events. In the same month, the company also announced a positive outcome from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding current good manufacturing practice (cGMP) production of IMNN-001 for the Phase 3 trial and potential commercialization. Production of IMNN-001 is conducted at IMUNON’s in-house manufacturing facility located in Huntsville, Alabama.

Conference Call and Webcast

IMUNON is hosting a conference call to discuss the Phase 3 OVATION 3 pivotal trial of IMNN-001 on Tuesday, March 25, 2025, at 2:00 p.m. ET. Company management will be joined by:

Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 Study Chair
L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health
To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Phase 3 protocol call. A live webcast of the call will also be available here.

The call will be archived for replay until April 8, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 9074731. An audio replay of the call will also be available here for 90 days.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On March 24, 2025 Agilent Technologies Inc. (NYSE: A) reported its role in supporting Autolus Therapeutics’ FDA approval for AUCATZYL, a recently approved CAR T therapy. Agilent’s advanced cell analysis instrumentation, specifically the xCELLigence Real-Time Cell Analysis (RTCA) technology, was applied in developing and validating AUCATZYL. The xCELLigence RTCA technology supported the development and implementation of the potency assay (Press release, Agilent, MAR 24, 2025, View Source [SID1234651384]). By providing precise and reliable cell analysis solutions, Agilent assisted Autolus in achieving the high standards required for FDA approval.

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Dr. Xiaobo Wang, Vice President and General Manager of the Cell Function and Phenotyping Business at Agilent stated, "Agilent is honored to have contributed to this significant milestone in cancer treatment. The collaboration between Agilent and Autolus highlights the importance of innovative technologies and cooperative efforts in advancing cancer therapies."

David Brochu, Chief Technical Officer at Autolus Therapeutics added, "Agilent’s support was invaluable in our journey to FDA approval. Agilent’s state-of-the-art xCELLigence RTCA technology facilitated the accuracy, reliability and precision of our potency analytical procedure."

The xCELLigence Real-Time Cell Analysis (RTCA) technology is a cutting-edge platform that continuously monitors cell behavior in real-time without using labels or dyes. This technology measures electrical impedance to provide dynamic information on cell numbers, viability, and morphology. Unlike traditional endpoint assays, xCELLigence RTCA offers real-time insights, enabling more accurate and timely decision-making in drug development. Its ability to deliver continuous, real-time data sets it apart in the market, providing researchers with a deeper understanding of cellular responses and enhancing the development of effective therapies.

Agilent and Autolus will attend the 2025 Hybrid US Bioassay Conference from March 24-25 in Tucson, Arizona. Mike Merges, Vice President of Analytical Development, QC Control Operations, Automation, and CMC (Chemistry, Manufacturing, and Controls) at Autolus, along with Jakub Dragun, Quality Control Consultant at Autolus, and Xiaobo Wang, VP/GM of the Cell Function and Phenotyping Business at Agilent, will present a Main Session Podium Talk titled: ‘Lessons Learned in CAR T Cell Product Potency Measurement: A Cross-Functional Investigation and the Importance of Partnership.’ The talk will be held Monday, March 24, from 1:30-2:00 PM in the Sabino Room at the Marriott Tucson University Park Hotel and is open to all conference attendees.

Agilent is committed to advancing scientific innovation and supporting groundbreaking therapies that enhance health outcomes. To learn more about Agilent’s real-time cell analysis solutions, visit Agilent Cell Analysis.

On March 24, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on developing oncology drugs, reported that it has submitted a new indication application (NDA) for sugemalimab to the European Medicines Agency (EMA) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed after concurrent or sequential chemoradiotherapy (CRT) (Press release, CStone Pharmaceauticals, MAR 24, 2025, View Source [SID1234656219]). This is the second indication CStone has advanced in the European market, following its initial EMA approval in 2024 for the first-line treatment of metastatic squamous and non-squamous NSCLC. If approved, sugemalimab will address a critical unmet need in Stage III NSCLC, becoming the second PD-(L)1 antibody approved for this indication in Europe . Furthermore, sugemalimab’s dual application in both Stage III and Stage IV NSCLC will further solidify its position as a core immunotherapy for lung cancer.

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This application is based on a multicenter, randomized, double-blind Phase III clinical study called GEMSTONE-301 , which aims to evaluate the efficacy and safety of sugemalimab as consolidation therapy for patients with unresectable Stage III NSCLC after CRT. The results of the GEMSTONE-301 study have been published in The Lancet Oncology, and the results show that:

Sugemalimab can significantly prolong patients’ progression-free survival (PFS) and reduce the risk of disease progression or death by 36%;
A clear trend toward overall survival (OS) benefit, with a 56% reduction in the risk of death ;
Consistent clinical benefits were observed regardless of whether patients received concurrent or sequential chemoradiotherapy;
The safety profile was good and no new risk signals were found.
Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "Following the successful approval of sugemalimab for the treatment of Stage IV NSCLC in Europe, we have been working closely with the EMA to actively expand its indication for earlier-stage lung cancer and other tumor types. Based on its outstanding efficacy and favorable safety profile, sugemalimab has the potential to address the unmet clinical needs of patients with Stage III NSCLC. Furthermore, we will continue to deepen our international strategic collaborations and work closely with regulatory agencies to increase global access to sugemalimab and ensure that this innovative therapy can benefit patients worldwide as soon as possible."

About Sugemalimab

Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform licensed from US-based Ligand Corporation . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab closely resembles the natural G-type immunoglobulin 4 (IgG4) response in humans, minimizing the potential risk of immunogenicity and related toxicities in patients. This offers unique advantages over similar drugs.

The European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have sensitizing EGFR mutations or genomic tumor alterations in ALK, ROS1, or RET.

Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (Zegemet ) :

First-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC and metastatic squamous NSCLC without EGFR or ALK gene mutations;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 CPS ≥ 5.

On March 24, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported its financial results for the fiscal year ended December 31, 2024 (Press release, Moleculin, MAR 24, 2025, View Source [SID1234651367]). As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, March 24, 2025 (details below).

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"This last year proved to be a very productive and substantial year for Moleculin. We believe that we continue to successfully execute on activities for our MIRACLE trial, supported by a growing body of positive preliminary data and encouraging interactions with FDA and clinical sites," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Looking ahead, we look forward to an exciting year with a number of potential value-driving milestones expected in the coming months. Importantly, with the clinical and regulatory progress made to date, we still expect to unblind preliminary data from the first 45 subjects in the second half of this year. Our team is dedicated to advancing the development of Annamycin and we look forward to providing additional updates."

Recent Highlights

Expanded global exclusivity for Annamycin with Notice of Intent to Grant for the European patent application titled, "Method of Reconstituting Liposomal Annamycin";
Received positive FDA guidance for acceleration of its registration-enabling MIRACLE trial for R/R Acute Myeloid Leukemia (AML) resulting in a smaller number of subjects in MIRACLE;
Received first country regulatory approval in Europe to begin enrolling for the MIRACLE trial;
Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged a leading contract research organization (CRO); and,
Announced new preclinical findings demonstrating significant activity of Annamycin in Venetoclax resistant AML model.
Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US, Europe and the Middle East.

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting. The amended protocol allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

Early activities include: Multiple first subjects in Ukraine are being screened and we expect to begin treatment by the end of March; Corresponding ethic committee approvals were received recently in Georgia and Egypt with the appropriate regulatory approvals remaining; and, multiple site evaluation and initiation visits are occurring and/or being scheduled.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756.

Expected Milestones for Annamycin AML Development Program

1Q – 3Q 2025 – Update on MIRACLE trial site selection/approvals by countries
1Q 2025 – First subject enrolled and treated in MIRACLE trial
2025 – Recruitment update for MIRACLE trial
2H 2025 – Data readout (n=45) unblinded efficacy/safety review
2H 2025 – 2026 – Impact of data readout (n=45) on regulatory pathway; Recruitment update
1H 2026 – Interim efficacy and safety data (n=~75-90) unblinded and Optimum Dose set for MIRACLE trial
2027 – Begin enrollment of 3rd line subjects in MIRACLE2
2027 – Enrollment ends in 2nd line subjects
2028 – Primary efficacy data for 2nd line subjects in MIRACLE
2028 – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2028 – Primary efficacy data for 2nd line subjects
2028 – Rolling NDA submission begins
Soft Tissue Sarcoma (STS) Lung Metastases

As previously announced, the Company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases. Subjects who had stable disease at the time of study discontinuation were followed for progression free response and overall survival. The clinical study report is finalized but not yet filed and is expected to be released by the end of April 2025.

Expected Milestones for Annamycin STS Lung Mets Development Program

1H 2025 – Final MB-107 data readout
2025 – Identify next phase of development / pivotal IIT (investigator-initiated-trial) program
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

Summary of Financial Results for the Full Year 2024

Research and development (R&D) expense was $17.7 million and $19.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in R&D of $1.8 million is mainly related to the $1.5 million WPD sublicense termination in 2023, which enabled the reacquisition of our intellectual property rights in certain territories, including parts of the European Union.

General and administrative (G&A) expenses were $8.8 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively. The decrease in G&A of $1.2 million was mainly attributable to a decrease in regulatory and legal services, and consulting & advisory fees.

As of December 31, 2024, the Company had cash and cash equivalents of $4.3 million. The Company believes that the existing cash and cash equivalents as of December 31, 2024, along with $9.3 million in gross proceeds received as part of the February 2025 financing activities will be sufficient to fund our planned operations into the third quarter of 2025.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties on Monday, March 24, 2024 at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

On March 24, 2025 Onconetix, Inc., (Nasdaq: ONCO) ("Onconetix" or the "Company"), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, reported that new clinical data of Proclarix was presented on March 23, 2025 during the 2025 European Association of Urology (EAU) congress, which data further demonstrates the strong clinical performance of Proclarix in a Danish cohort (Press release, Onconetix, MAR 24, 2025, View Source [SID1234651368]).

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The primary approach for early detection of prostate cancer is through testing serum levels of prostate-specific antigen (PSA). However, given the limited cancer specificity of PSA, Proclarix is addressing the urgent need for improved diagnosis by lowering the burden of potential over-detection of clinically insignificant prostate cancer resulting in unnecessary biopsies.

In the study presented, Proclarix was evaluated in prospectively collected samples from 808 patients with suspected prostate cancer. In the challenging subpopulation including 371 patients with an enlarged prostate and thus frequently presenting elevated PSA levels leading to false-positive results, a negative Proclarix test resulted in a probability of 5% or less for clinically significant cancer outperforming other diagnostic tools like %fPSA (14%, p=0.028) and the ERSPC (European Randomised Study of Screening for Prostate Cancer) risk calculator (20%, p=0.026). Proclarix avoided most biopsies (22%) and missing the least significant cancers (3 out of 101 patients). In the extended population including 654 patients with a PSA level of 2-20 ng/ml, the clinical performance of Proclarix was confirmed with a sensitivity of 96% and a significantly higher (p<0.001) specificity compared to both %fPSA and ERSPC risk calculator.

Primary investigator and presenter of the study, Ahmed H. Zedan, MD, PhD from Lillebaelt Hospital – University Hospital of Southern Denmark said: "Proclarix can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer and by minimizing the risk of missing clinically significant cancer".

About Proclarix

Proclarix is CE-certified under In Vitro Diagnostic Regulation ("IVDR") and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix is included in both the European (EAU) and American (AUA) guidelines.