Of the 14 participants enrolled and treated with lenzilumab plus azacitidine, ten are evaluable with three to eighteen months of follow-up and all ten have had a rapid clinical response
Building upon previously reported positive clinical responses, these additional data demonstrate statistically significant and clinically relevant improvements in hematologic outcomes, along with improvements in inflammatory markers, that occur in the early months after treatment initiation and appear durable
CMML is a rare, aggressive cancer; approximately 20% of patients survive three years from diagnosis
No new CMML medications with novel mechanisms of action have been approved in over 30 years and hypomethylating agents, such as azacitidine alone, are currently considered "standard of care"
Short Hills, New Jersey--(Newsfile Corp. - June 9, 2023) - Humanigen, Inc. (Nasdaq: HGEN) today extended previously reported results by presenting additional, statistically significant hematologic improvements and reductions in inflammatory markers from lenzilumab, its investigational drug, in a Phase 2/3 trial of treatment-naïve participants with chronic myelomonocytic leukemia and RAS-pathway mutations.
The additional data demonstrate that in all 10 participants with at least three months of treatment with both lenzilumab and azacitidine, blood monocyte count decreased fivefold (P=0.03), the percentage of blast cells and pro-monocytes decreased more than twofold (P=0.04), and C-reactive protein decreased more than threefold (P=NS) with improvements noted after both 3 months and 6 months of this combination treatment. These results suggest lenzilumab may normalize hematologic and inflammatory aberrations in CMML and improve the condition of participants. All ten evaluable participants had a rapid clinical response.
CMML is a rare, aggressive cancer in which levels of monocytes, blast cells, and pro-monocytes are significantly elevated from normal levels. These pathologic changes are accompanied by significantly elevated pro-inflammatory markers, including C-reactive protein. Current treatment options for CMML patients are limited to blood transfusions, hydroxyurea, and supportive care alongside the current standard of care, which includes hypomethylating agents such as azacitidine and decitabine, which have limited response rates of 7% to 18%1, 2, 3 with no proven increase in overall survival.
In the last 30 years, no new medicines with a novel mechanism of action have been approved for CMML patients who are at high risk of death or disease progression.4 Only about 20% of patients diagnosed with CMML survive for three years.5
"The PREACH-M trial findings to date, indicate that lenzilumab may improve treatment response in CMML," said Humanigen Chairman and CEO Cameron Durrant, MD, MBA. "These results may create the possibility for lenzilumab development in myelodysplastic leukemias. I look forward to sharing the data at the poster presentation at the 2023 European Hematology Association congress in Frankfurt, Germany."
The presentation, entitled "Lenzilumab and Azacitidine Improve Hematologic Alterations of Chronic Myelomonocytic Leukemia in the PREACH-M Trial," highlighted new data in poster format (P737) at 6:00 pm CEST on June 9, 2023, during the 2023 European Hematology Association congress.
"Patients with CMML are normally treated with hypomethylating agents such as azacitidine, with reported response rates of just 7% to 18%, usually of limited duration," said principal investigator Daniel Thomas, MD, PhD, program leader for blood cancer research at SAHMRI and an associate professor of medicine at the University of Adelaide. "Treating patients with lenzilumab appears to be improving clinical parameters, quality of life and systemic inflammation in the patients studied so far, and patients appear to be tolerating lenzilumab well. Critically, clinical responses appear to occur early, prior to the fourth monthly treatment cycle. No patients have relapsed, and we currently have two patients remaining on treatment for more than 18 months."
Lenzilumab, a granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralizing antibody, prevents GM-CSF from binding to receptors on hematologic progenitor cells. When GM-CSF binds to those receptors, it triggers normal myelocyte proliferation and maturation. In the presence of RAS-pathway mutations, GM-CSF contributes to the hyperproliferation of myelocytes in myelodysplastic leukemias such as CMML, juvenile myelomonocytic leukemia (JMML), and acute myeloid leukemia (AML).6,7,8 Therefore, lenzilumab's ability to prevent GM-CSF binding to its receptor may inhibit the hyperproliferation in these conditions.
PREACH-M (PREcision Approach to CHronic Myelomonocytic Leukemia), a non-randomized, open-label trial, is being conducted at multiple sites in Australia. It is sponsored by the South Australian Health and Medical Research Institute (SAHMRI), with grant funding from the Australian government and the study drug supplied by Humanigen.
As of May 9, 2023, 14 CMML patients at intermediate or high risk of death or disease progression have received at least one dose of lenzilumab, along with azacitidine. Ten of those participants were evaluable based on at least three months of follow-up, and each experienced a rapid clinical benefit. Twenty-one grade 3 or 4 serious adverse events were observed, of which investigators assessed five as possibly related to lenzilumab.
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About CMML
CMML is an orphan disease with an approximate annual incidence of 1-4 cases per million1 in western countries and has limited therapeutic options. CMML is an aggressive and poorly understood cancer with only about 20% of patients surviving up to the three-year mark.9
The incidence of CMML in the US, UK, and Australia is about 1,700 patients annually.9 As an orphan disease, lenzilumab may qualify for certain regulatory and commercial advantages that could expedite development and potential approval. Humanigen and the Principal Investigator are assessing regulatory pathways that may enable early results to support a regulatory submission and potential approval by the Therapeutic Goods Administration in Australia, which could be expanded through Project Orbis10 to the United States and the United Kingdom ().
About the PREACH-M Trial
PREACH-M (PREcision Approach to CHronic Myelomonocytic Leukemia) is a Phase 2/3, non-randomized, open-label clinical trial investigating precision medicine for adults with CMML.11 This trial investigates treatment response rates determined by the Savona Criteria for patients with CMML after administration of lenzilumab alongside azacitidine in patients with RAS pathway mutations. The study also measures the patients' quality of life, using the MPN Symptoms Assessment Form: Total Symptom Score.
Fourteen study participants were enrolled and treated with lenzilumab and azacitidine as of May 9, 2023, of which ten were evaluable for hematologic and inflammatory parameters based on at least three months of follow-up. The initial data demonstrate that blood monocyte count decreased by fivefold (p=0.03), percentage of blast cells and pro-monocytes decreased by more than twofold (p=0.04), platelet count and hemoglobin concentration both increased and remained elevated at 12 months (p=0.07 and p=0.02, respectively), and craniocaudal spleen size decreased by nearly 50% by 6 months (p=0.03). The inflammatory marker, C-reactive protein decreased by more than threefold (p=NS). All ten evaluable participants had a rapid clinical response.
During the active treatment phase of the study, participants are required to attend clinic visits on Days 1 & 15 of the first cycle, and then on Day 1 of each subsequent 28-day cycle to assess how the participant is tolerating the therapy and ensure ongoing safety.12 In addition to regular safety blood tests throughout each cycle, participants' disease response assessments are scheduled after 3, 6, 12 and 24 cycles of therapy to measure their disease response.12 Such assessments include blood tests, bone marrow aspirate and trephine, ultrasound of the spleen, physical exam and assessment of transfusion requirements and clinical symptoms.12
Participants who complete 24 cycles of active treatment enter the follow-up phase of the study where they are followed up every 6 months for 24 months for survival, disease status and further CMML-related treatment.11 For patients with confirmed progressive disease or relapse during the active treatment phase of the study, further study treatment will cease. Patients remain on study and are followed up for disease status, survival, and further CMML-related treatment every 6 months until 48 months from Cycle 1, Day 1.11 During the follow-up period, participants no longer receive any investigational drugs but are permitted to receive any CMML treatment at the discretion of the treating clinician.
As part of the screening process, participants are required to have a bone marrow aspirate and trephine to test for certain acquired mutations that can be present in CMML.11 The study is seeking participants with TET2 and/or RAS pathway mutations. Participants with RAS pathway mutations or both TET2 and RAS mutations, receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on Days 1-5, 8-9 or Days 1-7 for a total of 7 doses per 28-day cycle) in combination with lenzilumab (administered intravenously at a dose of 552mg on Days 1 & 15 of Cycle 1. Day 1 only for all subsequent cycles).11
The trial is sponsored by the South Australian Health and Medical Research Institute ("SAHMRI") and funded by a Medical Research Future Fund grant from the National Health and Medical Research Council of the Australian government to the University of Adelaide. Humanigen provides lenzilumab for use in the study through its Australian subsidiary, Humanigen Australia Pty Ltd. Enrollment is open to newly diagnosed CMML patients who haven't received any treatment.
Anyone who is interested in learning more about the study, or obtaining additional information can visit the Australian New Zealand Clinical Trials Registry ().
About Humanigen
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), is a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor. Humanigen is developing lenzilumab as a treatment for chronic myelomonocytic leukemia. Humanigen is also exploring the use of lenzilumab to prevent toxicities associated with CAR-T therapy through investigator-initiated trials. Humanigen is also developing an antibody drug conjugate (ADC) utilizing its EphA-3 targeted monoclonal antibody ifabotuzumab ("ifab") for solid tumors. For more information, visit .
About the European Hematology Association
The European Hematology Association serves medical professionals, researchers, and scientists with an active interest in hematology. They are the largest European-based organization connecting hematologists worldwide to support career development and research, harmonize hematology education, and advocate for hematologists and hematology.
About the EHA Hybrid Congress
The EHA2023 Hybrid Congress, being held in Frankfurt, Germany, from June 8-11, 2023, offers an interactive, comprehensive program dedicated to clinical research and practice, basic and translational research, as well as important opportunities for collaboration with stakeholders in the field of hematology. The educational and scientific program highlights state-of-the-art clinical practice, the latest findings in hematology research, and recent approaches on the diagnosis and treatment of hematologic diseases.
Forward-Looking Statements about Humanigen
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to continue as a going concern; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
Humanigen Investor Relations Contact
Ed Jordan
Chief Commercial Officer
IR@humanigen.com
650-243-3181
Humanigen Media Relations Contact
Charlotte Wray
cwray@rxmedyn.com
646-247-3405
References
- Costa, R., et. al. (2010). Activity of azacitidine in chronic myelomonocytic leukemia. Cancer, 117(12), 2690-2696. .
- South Australian Registry data, South Australian Health and Medical Research Institute, April 14, 2021
- Pleyer, L., et. al. (2014). Azacitidine in CMML: Matched-pair analyses of daily-life patients reveal modest effects on clinical course and survival. Leukemia Research, 38(4), 475-483.
- Aim of first-ever CMML study - to improve survival. Leukaemia Foundation. (2023, January 3). Retrieved January 3, 2023, from
- Ma, L., Jiang, L., Yang, W., Luo, Y., Mei, C., Zhou, X., Xu, G., Xu, W., Ye, L., Ren, Y., Lu, C., Lin, P., Jin, J., & Tong, H. (2021). Real-world data of chronic myelomonocytic leukemia: A chinese single-center retrospective study. Cancer medicine, 10(5), 1715-1725.
- Gupta, A. et al. (2021). Juvenile myelomonocytic leukemia-A comprehensive review and recent advances in management. American Journal of Blood Research, 11(1), 1-21. Retrieved July 21, 2022, from
- Padron, E., et al. (2013). GM-CSF-dependent PSTAT5 sensitivity is a feature with therapeutic potential in chronic myelomonocytic leukemia. Blood, 121(25), 5068-5077.
- Emanuel, P. D., et al. (1991). Selective hypersensitivity to granulocyte-macrophage colony-stimulating factor by juvenile chronic myeloid leukemia hematopoietic progenitors. Blood, 77(5), 925-929.
- Incidence extrapolated by applying NIH SEER incidence rate of five per one million people found at to the population of U.S., UK, and Australia, Prevalence data also from NIH SEER.
- U.S. Food and Drug Administration. A framework for concurrent submission and review of Oncology Products. Retrieved March 20, 2023, from
- Australian New Zealand Clinical Trials Registry. Retrieved March 20, 2023, from
- Preach-M: Precision medicine for chronic myelomonocytic leukaemia in adults: A phase II trial studying the efficacy of lenzilumab and high dose ascorbate with azacitidine based on molecular profiling. PREACH-M - Victorian Cancer Trials Link. (n.d.). Retrieved January 3, 2023, from
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在註冊並接受倫齊魯單抗加阿扎胞苷治療的14名參與者中,有10名在接受三到十八個月的隨訪後可以進行評估,所有十名參與者的臨床反應都很快
在先前報告的陽性臨床反應的基礎上,這些額外數據表明,血液學預後具有統計學意義且具有臨床相關性的改善,炎症標誌物也有所改善,這些改善發生在治療開始後的最初幾個月,而且看似持久
CMML 是一種罕見的侵襲性癌症;大約 20% 的患者在診斷後存活了三年
30多年來,沒有一種具有新作用機制的CMML新藥物獲得批准,而低甲基化藥物,例如單獨的阿扎胞苷,目前被視爲 “標準治療”
新澤西州肖特希爾斯--(Newsfile Corp.,2023年6月9日)——Humanigen, Inc.(納斯達克股票代碼:HGEN)今天在一項針對患有慢性骨髓單核細胞病和白血病的天真治療參與者的2/3期試驗中,公佈了更多具有統計學意義的血液學改善和炎症標誌物的降低,從而延續了先前公佈的結果 拉斯-路徑突變。
其他數據表明,在同時接受倫齊魯單抗和阿扎西替丁治療至少三個月的所有10名參與者中,血液單核細胞計數下降了五倍(P=0.03),爆炸細胞和前單核細胞的百分比下降了兩倍多(P=0.04),而且 C 反應蛋白下降了三倍以上(P=NS),這種聯合治療的3個月和6個月後均有改善。這些結果表明 lenzilumab 可以使CMML的血液學和炎症異常正常化並改善參與者的狀況。所有十名可評估的參與者的臨床反應都很快。
CMML 是一種罕見的侵襲性癌症,其中單核細胞、衝擊細胞和原單核細胞的水平顯著高於正常水平。這些病理變化伴隨着促炎標誌物的顯著升高,包括 C 反應蛋白。CMML患者目前的治療選擇僅限於輸血、羥基脲和支持性護理,以及目前的護理標準,其中包括阿扎胞苷和地西他濱等低甲基化藥物,其反應率有限,爲7%至18%1、2、3 總存活率並未得到證實。
在過去的30年中,沒有一種具有新作用機制的新藥獲准用於死亡或疾病進展風險高的CMML患者。4 在被診斷爲CMML的患者中,只有大約20%可以存活三年。5
Humanigen董事長兼首席執行官、醫學博士、工商管理碩士卡梅隆·杜蘭特說:“迄今爲止的PREACH-M試驗結果表明,lenzilumab可以改善CMML的治療反應。”“這些結果可能爲lenzilumab在骨髓增生異常白血病中的開發創造了可能性。我期待在德國法蘭克福舉行的2023年歐洲血液學協會大會的海報發佈會上分享這些數據。”
該演講題爲 “Lenzilumab和Azacitidine改善PREACH-M試驗中慢性骨髓單核細胞白血病的血液學改變”,在2023年歐洲血液學協會大會期間,歐洲中部標準時間2023年6月9日下午 6:00,重點介紹了海報格式(P737)的新數據。
SAHMRI血液癌研究項目負責人、阿德萊德大學醫學副教授丹尼爾·托馬斯說:“CMML患者通常接受阿扎胞苷等低甲基化藥物治療,報告的反應率僅爲7%至18%,通常持續時間有限。”“迄今爲止所研究的患者的lenzilumab治療患者似乎可以改善臨床參數、生活質量和全身性炎症,而且患者對lenzilumab的耐受性似乎良好。至關重要的是,臨床反應似乎很早就出現了,在第四個月的治療週期之前。沒有患者復發,我們目前有兩名患者仍在接受治療超過18個月。”
Lenzilumab 是一種粒細胞巨噬細胞集落刺激因子 (GM-CSF) 中和抗體,可防止 GM-CSF 與血液學祖細胞上的受體結合。當 GM-CSF 與這些受體結合時,它會觸發正常的骨髓細胞增殖和成熟。在場的情況下 拉斯-pathay 突變,GM-CSF 有助於骨髓增生異常白血病(例如 CMML、幼年骨髓單核細胞白血病 (JMML) 和急性髓系白血病 (AML))中骨髓細胞的過度增殖。6,7,8 因此,在這些情況下,lenzilumab 阻止 GM-CSF 與其受體結合的能力可能會抑制過度增殖。
PREACH-M (前切割 A接近 CH羅尼克的 Myelomonocytic Bilocypare)是一項非隨機、開放標籤的試驗,正在澳大利亞的多個地點進行。它由南澳大利亞健康與醫學研究所(SAHMRI)贊助,由澳大利亞政府資助,研究藥物由Humanigen提供。
截至2023年5月9日,14名處於中度或高死亡或疾病進展風險的CMML患者已經接受了至少一劑倫齊魯單抗和阿扎西替丁。根據至少三個月的隨訪,對其中十名參與者進行了評估,每位參與者都獲得了快速的臨床益處。觀察到21起3級或4級嚴重不良事件,研究人員評估其中五起可能與lenzilumab有關。
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關於 CMML
CMML 是一種孤兒病,年發病率約爲每百萬人中有 1-4 例1 在西方國家,治療選擇有限。CMML 是一種侵襲性、鮮爲人知的癌症,只有大約 20% 的患者存活到三年大關。9
在美國、英國和澳大利亞,CMML 的發病率每年約爲 1,700 名患者。9 作爲一種孤兒病,lenzilumab可能有資格獲得某些監管和商業優勢,這可能會加快開發和潛在的批准。Humanigen和首席研究員正在評估監管途徑,這些途徑可能使早期結果爲澳大利亞治療用品管理局提交的監管文件和可能的批准提供支持,該批准可以通過Orbis項目得到擴展10 到美國和英國 ().
關於 PREACH-M 試用版
PREACH-M (前切割 A接近 CH羅尼克的 Myelomonocytic Bilocypare)是一項2/3期、非隨機、開放標籤的臨床試驗,旨在研究針對患有CMML的成年人的精準醫療。11 該試驗調查了根據薩沃納標準確定的CMML患者在給藥倫齊魯單抗和阿扎西替丁後的治療反應率 拉斯 途徑突變。該研究還使用MPN症狀評估表:總症狀評分來衡量患者的生活質量。
截至2023年5月9日,有14名研究參與者入組並接受了倫齊魯單抗和阿扎西替丁的治療,根據至少三個月的隨訪,其中十名參與者的血液學和炎症參數可以評估。初步數據表明,血液單核細胞計數減少了五倍(p=0.03),細胞和前單核細胞百分比下降了兩倍以上(p=0.04),血小板計數和血紅蛋白濃度均增加並在12個月後保持升高(分別爲p=0.07和p=0.02),顱尾脾大小在6個月內下降了近50%(p=0.03)。炎症標誌物 C 反應蛋白降低了三倍以上(p=nS)。所有十名可評估的參與者的臨床反應都很快。
在研究的積極治療階段,參與者需要在第一個週期的第 1 天和第 15 天就診,然後在隨後的每個 28 天週期的第 1 天就診,以評估參與者對治療的耐受性並確保持續的安全性。12 除了在每個週期中定期進行安全血液檢查外,參與者的疾病反應評估計劃在3、6、12和24個治療週期後進行,以衡量他們的疾病反應。12 此類評估包括血液檢查、骨髓穿刺和甲氨酸、脾臟超聲檢查、體格檢查以及輸血需求和臨床症狀評估。12
完成24個週期的積極治療的參與者進入研究的隨訪階段,每6個月對他們進行一次隨訪,持續24個月,以瞭解存活率、疾病狀態和進一步的cmml相關治療。11 對於在研究的積極治療階段確診爲進行性疾病或復發的患者,進一步的研究治療將停止。從第 1 個週期第 1 天開始,每 6 個月對患者進行一次隨訪以瞭解疾病狀態、存活率和進一步的 cmml 相關治療。11 在隨訪期間,參與者不再接受任何研究藥物,但允許接受任何CMML治療,由治療的臨床醫生自行決定。
作爲篩查過程的一部分,參與者需要接受骨髓穿刺和甲氨酸,以檢測 CMML 中可能存在的某些獲得性突變。11 該研究正在尋找具有TET2和/或RAS途徑突變的參與者。RAS 途徑突變或兩者兼而有之的 TET2 和 拉斯 突變,接受阿扎胞苷(以75mg/m的劑量皮下給藥)2 在第 1-5 天、第 8-9 天或第 1-7 天,每 28 天週期共接種 7 劑)與 lenzilumab 聯合使用(在第 1 天和第 15 天靜脈注射,劑量爲 552 毫克)。第 1 天僅適用於所有後續週期)。11
該試驗由南澳大利亞健康與醫學研究所(“SAHMRI”)贊助,並由澳大利亞政府國家衛生和醫學研究委員會向阿德萊德大學提供的醫學研究未來基金撥款資助。Humanigen通過其澳大利亞子公司Humanigen Australia Pty Ltd提供用於該研究的lenzilumab。尚未接受任何治療的新診斷的CMML患者可以註冊。
任何有興趣瞭解有關該研究的更多信息或獲取更多信息的人都可以訪問澳大利亞新西蘭臨床試驗註冊中心 ()。
關於 Humanigen
Humanigen, Inc.(納斯達克股票代碼:HGEN)(“Humanigen”)是一家臨床階段的生物製藥公司,專注於開發lenzilumab,這是一種與粒細胞巨噬細胞集落刺激因子結合和中和的同類首創抗體。Humanigen正在開發lenzilumab作爲慢性骨髓單核細胞白血病的治療方法。Humanigen還在探索使用lenzilumab通過研究者發起的試驗來預防與CAR-T療法相關的毒性。Humanigen還在開發一種抗體藥物偶聯物(ADC),利用其針對實體瘤的epha-3靶向單克隆抗體ifabotuzumab(“ifab”)。欲瞭解更多信息,請訪問。
關於歐洲血液學協會
歐洲血液學協會爲對血液學有濃厚興趣的醫學專業人員、研究人員和科學家提供服務。他們是歐洲最大的連接全球血液學家的組織,旨在支持職業發展和研究,協調血液學教育,倡導血液學家和血液學。
關於 EHA 混合大會
EHA2023 Hybrid Congress 將於 2023 年 6 月 8 日至 11 日在德國法蘭克福舉行,提供一項互動式綜合計劃,專門用於臨床研究和實踐、基礎和轉化研究,以及與血液學領域利益相關者合作的重要機會。該教育和科學項目重點介紹了最先進的臨床實踐、血液學研究的最新發現以及血液學疾病診斷和治療的最新方法。
關於 Humanigen 的前瞻性陳述
除本新聞稿中包含的歷史事實陳述外,所有陳述均爲前瞻性陳述。前瞻性陳述反映了管理層對未來業績或事件的當前認識、假設、判斷和預期。儘管管理層認爲此類陳述中反映的預期是合理的,但它們並不能保證此類預期會被證明是正確的,您應該意識到,實際事件或結果可能與前瞻性陳述中包含的事件或結果存在重大差異。諸如 “意願”、“期望”、“打算”、“計劃”、“潛力”、“可能”、“目標”、“加速”、“繼續” 之類的詞語以及類似的表達方式可以識別前瞻性陳述。
前瞻性陳述受許多風險和不確定性的影響,包括但不限於我們缺乏盈利能力和需要額外資本才能繼續經營所固有的風險;我們依賴合作伙伴進一步開發候選產品;任何新藥品的開發、獲得必要的監管授權和批准以及推出所固有的不確定性;未決或未來的訴訟或仲裁的結果;以及各種風險和不確定性在我們最新的年度和季度報告以及向美國證券交易委員會提交的其他文件的 “風險因素” 部分中進行了描述。
本警示通知對所有前瞻性陳述進行了明確的全部限定。您不應依賴任何前瞻性陳述來預測未來事件。除非法律要求,否則我們沒有義務修改或更新本新聞稿中作出的任何前瞻性陳述,以反映本新聞稿發佈之日之後的事件或情況,反映新信息或意外事件的發生,也沒有義務更新每種情況下的實際業績可能與前瞻性陳述中的預期存在重大差異的原因。
Humanigen 投資者關係聯繫人
埃德·喬丹
首席商務官
IR@humanigen.com
650-243-3181
Humanigen 媒體關係聯繫人
夏洛特·雷
cwray@rxmedyn.com
646-247-3405
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- 伊曼紐爾,P.D. 等人(1991)。幼年慢性粒細胞白血病造血祖細胞對粒細胞-巨噬細胞集落刺激因子的選擇性超敏反應。Blood,77 (5),925-929。
- 發病率是通過將美國國立衛生研究院(NIH SEER)的每百萬人中有五人發病率應用於美國、英國和澳大利亞的人口推斷出來的,患病率數據也來自美國國立衛生研究院 SEER。
- 美國食品和藥物管理局。 同時提交和審查腫瘤產品的框架。檢索於 2023 年 3 月 20 日,來自
- 澳大利亞新西蘭臨床試驗註冊處。檢索於 2023 年 3 月 20 日,來自
- Preach-M:成人慢性骨髓單核細胞白血病的精準醫學:一項基於分子譜研究lenzilumab和大劑量抗壞血酸與阿扎西替丁療效的II期試驗。PREACH-M-維多利亞州癌症試驗鏈接。(未註明)。檢索於 2023 年 1 月 3 日,來自
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