A Phase 1 Study of GRN163L (Imetelstat) in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia That is in Second or Greater Relapse or That is Refractory to Relapse Therapy; Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia in First or Greater Relapse or is Refractory to Relapse Therapy

This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.

Start Date12 Jul 2024

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT05583552 / Active, not recruitingPhase 2

A Phase II Study Evaluating the Efficacy and Safety of Imetelstat in Patients With HR Myelodysplastic Syndromes or AML Failing HMA-based Therapy

The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement, and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that is relapsed/refractory to hypomethylating agents (HMAs) treatment. Responding patients are eligible to continue treatment until loss of response/disease progression.

Start Date05 Jun 2023

Sponsor / Collaborator

GCP Service International Ltd & Co KG

[+6]

NCT05371964 / RecruitingPhase 1

An Open Label, Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Patients With Myelofibrosis

The purpose of the study is to identify the recommended Part 2 dose (R2PD) of imetelstat in combination with ruxolitinib in participants with myelofibrosis (MF) in Part 1, and to evaluate the safety and clinical activity of the R2PD of imetelstat in combination with ruxolitinib in participants with MF in Part 2.

Start Date04 May 2022

Sponsor / Collaborator

Geron Corp.

100 Clinical Results associated with Imetelstat

100 Translational Medicine associated with Imetelstat

100 Patents (Medical) associated with Imetelstat

127

Literatures (Medical) associated with Imetelstat

01 Jan 2024·Lancet (London, England)Q1 · MEDICINE

Q1 · MEDICINE

Article

Author: Wan, Ying ; Valcárcel, David ; Illmer, Thomas ; Platzbecker, Uwe ; Shah, Sheetal ; Fenaux, Pierre ; Zeidan, Amer M ; Díez-Campelo, Maria ; Jonášová, Anna ; Santini, Valeria ; Dougherty, Souria ; Savona, Michael R ; Sun, Libo ; Bělohlávková, Petra ; Ikin, Annat ; Madanat, Yazan F ; Navada, Shyamala ; Feller, Faye ; Huang, Fei ; Komrokji, Rami S ; Sherman, Laurie J ; Berry, Tymara ; Xia, Qi ; Sekeres, Mikkael A

BACKGROUND:

Unmet medical needs remain in patients with red blood cell transfusion-dependent (RBC-TD) lower-risk myelodysplastic syndromes (LR-MDS) who are not responding to or are ineligible for erythropoiesis-stimulating agents (ESAs). Imetelstat, a competitive telomerase inhibitor, showed promising results in a phase 2 trial. We aimed to compare the RBC transfusion independence (RBC-TI) rate with imetelstat versus placebo in patients with RBC-TD LR-MDS.

METHODS:

In phase 3 of IMerge, a double-blind, placebo-controlled trial conducted in 118 sites including university hospitals, cancer centres, and outpatient clinics in 17 countries, patients (aged ≥18 years) with ESA-relapsed, ESA-refractory, or ESA-ineligible LR-MDS (low or intermediate-1 risk disease as per International Prognostic Scoring System [IPSS] criteria) were randomly assigned via a computer-generated schedule (2:1) to receive imetelstat 7·5 mg/kg or placebo, administered as a 2-h intravenous infusion, every 4 weeks until disease progression, unacceptable toxic effects, or withdrawal of consent. Randomisation was stratified by previous RBC transfusion burden and IPSS risk group. Patients, investigators, and those analysing the data were masked to group assignment. The primary endpoint was 8-week RBC-TI, defined as the proportion of patients without RBC transfusions for at least 8 consecutive weeks starting on the day of randomisation until subsequent anti-cancer therapy, if any. Primary efficacy analyses were performed in the intention-to-treat population, and safety analyses were conducted in patients who received at least one dose of trial medication or placebo. This trial is registered with ClinicalTrials.gov (NCT02598661; substudy active and recruiting).

FINDINGS:

Between Sept 11, 2019, and Oct 13, 2021, 178 patients were enrolled and randomly assigned (118 to imetelstat and 60 to placebo). 111 (62%) were male and 67 (38%) were female. 91 (77%) of 118 patients had discontinued treatment by data cutoff in the imetelstat group versus 45 (75%) in the placebo group; a further one patient in the placebo group did not receive treatment. Median follow-up was 19·5 months (IQR 12·0-23·4) in the imetelstat group and 17·5 months (12·1-22·7) in the placebo group. In the imetelstat group, 47 (40% [95% CI 30·9-49·3]) patients had an RBC-TI of at least 8 weeks versus nine (15% [7·1-26·6]) in the placebo group (rate difference 25% [9·9 to 36·9]; p=0·0008). Overall, 107 (91%) of 118 patients receiving imetelstat and 28 (47%) of 59 patients receiving placebo had grade 3-4 treatment-emergent adverse events. The most common treatment-emergent grade 3-4 adverse events in patients taking imetelstat were neutropenia (80 [68%] patients who received imetelstat vs two [3%] who received placebo) and thrombocytopenia (73 [62%] vs five [8%]). No treatment-related deaths were reported.

INTERPRETATION:

Imetelstat offers a novel mechanism of action with durable transfusion independence (approximately 1 year) and disease-modifying activity for heavily transfused patients with LR-MDS who are not responding to or are ineligible for ESAs.

FUNDING:

Janssen Research & Development before April 18, 2019, and Geron Corporation thereafter.

01 Nov 2023·Bulletin du cancer

Traitement des syndromes myélodysplasiques de bas risque

Review

Author: Park, Sophie

For low-risk myelodysplastic syndromes, the goal of treatment is to correct cytopenias or their consequences. Erythropoiesis-stimulating agents have an important role in the management of anemia. In this chapter, we will detail the response to ESAs, the factors predictive of response to ESAs. However, the search for new therapeutic options for low-risk, ESA-resistant MDS remains necessary as the incidence of AML transformation of the patients is higher. We can retain luspatercept for MDS with excess ring of sideroblasts, lenalidomide, and some molecules currently being tested such as imetelstat or roxedustat. However, the search for new therapeutic options for ESA-resistant low-risk MDS remains necessary. We can use androgenotherapy or TPO agonists in limited access for symptomatic thrombocytopenia.

01 Sep 2023·Future oncology (London, England)

Review

Author: Badar, Talha ; Madanat, Yazan F ; Zeidan, Amer M

The majority of lower-risk myelodysplastic syndromes/neoplasms patients present with anemia. Historically, these patients were treated with erythropoiesis-stimulating agents (ESA), with modest responses. A subset of these patients with del(5q) may do better with lenalidomide. Recently, in randomized trials, luspatercept has shown better responses compared with ESAs in treatment-naive patients and imetelstat in patients refractory to ESAs. Other evaluated novel compounds (fostamatinib, H3B-880, roxadustat, pyruvate kinase receptor activator) have not yet shown meaningful efficacy. More needs to be done to improve outcomes; in pursuance of this, participation in clinical trials evaluating novel therapies should be encouraged. While lower-risk myelodysplastic syndromes/neoplasms tend to have an indolent course, a subset of them has a dismal prognosis. Improving prognostication and serial monitoring will help in identifying high-risk patients for appropriate management.

104

News (Medical) associated with Imetelstat

26 Jun 2024

·www.biopharmadive.com

After 33 years, Geron’s first approval marks a turn in Nobel-winning science

Faye Feller, executive vice president and chief medical officer of the biotechnology company Geron, was giving her child a bath when her husband ran into the bathroom with her cellphone.Somethings going on at work, he said. Gerons blood cancer drug, a first-of-its-kind treatment called imetelstat, had just been approved by the Food and Drug Administration.Feller was immediately thrilled, but the news really hit home when she logged onto her companys website following the announcement.I saw the popup that said, Now approved. Rytelo in the U.S., she said, referring to the drugs new brand name. That brought tears to my eyes.In the biopharmaceutical industry, success is measured in decades. The lobbying group PhRMA estimates it takes an average of 10 to 15 years and $2.6 billion to develop one new medicine. Even by this standard, Rytelo had a long path to approval. The drug had been in the works for 33 years, including about 20 years of development in patients, Feller said.We've had a strong belief in bringing this mechanism to patients that has really persisted, Feller said.That mechanism is based on the Nobel Prize-winning science of telomeres, specialized DNA sequences at the ends of chromosomes that dictate the lifespan of a cell, and telomerase, an enzyme that lengthens telomeres and keeps the cell alive.Cancer cells upregulate telomerase in order to maintain immortality, Feller said. By targeting cancer cells that have this abnormally excessive expression of telomerase, we're getting down to treat an underlying cause of disease.After initial studies in other cancers, investigators saw signals in blood malignancies, Feller said. Now, Rytelo is approved in adult patients with lower-risk myelodysplastic syndromes who have transfusion-dependent anemia. Because of their anemia, these patients become dependent on frequent red blood cell transfusions, which can reduce quality of life and shorten survival. Moreover, these patients need transfusions at least twice a month and monitoring in between.I believed in the team and I believed in the drug. I thought, as a drug developer, this was the most de-risked risk I could take.Faye FellerExecutive vice president, chief medical officer, GeronRytelo has the potential to allow patients to replace frequent and often unpredictable transfusions with a single monthly dose of the drug.We anticipate that this can ease some of the sociological [and] psychological burden of transfusions, in addition to the clinical benefits, Feller said.A winding pathRytelos long journey to approval began when two scientists,Elizabeth Blackburn and Carol Greider, discovered telomerase in 1984. Eventually, that discovery led to breakthroughs for telomerases role in cancer; the formation of Geron, for which Blackburn and Greider were scientific advisors; and eventually, the Nobel Prize for the duo.The drug had several stops and starts over the years as Geron looked for the appropriate cancer to target. Even after identifying hematologic myeloid malignancies, Geron experienced another bump in the road when, after four years, Johnson & Johnson, Janssen Pharmaceuticals division chose to end an alliancewith the company to help develop and commercialize imetelstat.The ill-fated deal was what brought Feller to Geron. Janssen had recruited her from Memorial Sloan Kettering Cancer Center in New York to work on imetelstat. After Janssen terminated the partnership, Feller and others moved to Geron to continue working on the drug. She called moving to a small biotech scary but definitely worth it.I believed in the team and I believed in the drug, she said. I thought, as a drug developer, this was the most de-risked risk I could take.In addition, Feller credits a large investor community and financial institutions that also have this belief in the science and in the data and in the potential and have supported us along the way.Now, the company is commercializing Rytelo and advancing the rest of its pipeline, which includes a number of programs in the discovery, preclinical and clinical stages. Geron is also investigating telomerase inhibition across several myeloid hematologic malignancies.Among them is a phase 3 trial of imetelstat in patients with myelofibrosis.We're pretty proud that we're the first study in this patient space to look at overall survival as a primary endpoint, Feller said. Once that study reads out successfully, that hopefully will be our next indication.Meanwhile, Geron is planning a targeted launch of Rytelo to a concentrated prescriber base of approximately 8,000 [healthcare providers]. This covers approximately 2,200 targeted accounts, where we expect around 70% of patients to be treated in the community hematology setting, a company spokesperson told PharmaVoice via email. Geron expects Rytelo to be available in the distribution channel by the end of this month.The company believes Rytelo can become part of the standard of care, since theres a need for additional therapies in lower-risk myelodysplastic syndrome and about 10% of those patients have very limited treatment options. Other subsections of the population also have poorer outcomes and a high transfusion burden, the spokesperson said.Updated forecasts show Rytelo sales could reach $791 million in 2028, higher than the $737 million predicted in April, and may surpass $1 billion in 2030, an Evaluate spokesperson told PharmaVoice.Now, Feller said theres huge enthusiasm and excitement among physicians to bring Rytelo to patients. After popping that initial bottle of champagne, shes turning back to drug research.With the approval, we're transitioning into a commercial company, she said. But it's really important to me and incumbent on me to maintain our strong development. '

Drug ApprovalPhase 3

07 Jun 2024

·firstwordpharma.com

Geron gets first approved drug, with FDA nod for Rytelo in MDS

The FDA approved Geron’s oligonucleotide telomerase inhibitor Rytelo (imetelstat) for the treatment of adults with transfusion-dependent lower-risk myelodysplastic syndromes (LR-MDS) who are ineligible for erythropoiesis-stimulating agents (ESA) or have inadequate response to them. The clearance marks the company’s first authorised product since it was founded in 1990, with imetelstat initially entering development in 2005.“With the approval…patients with lower-risk MDS can potentially experience…greater than 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anaemia,” commented Geron CEO John Scarlett. The FDA clearance, announced ahead of the planned PDUFA date of June 16, sent the company’s shares up as much as 23% on Friday.The approval is backed by the Phase III IMerge study, wherein nearly 40% of patients receiving Rytelo met the main goal of independence from red-blood-cell transfusions (RBC-TI) at eight weeks, compared with only 15% of placebo recipients. Furthermore, the drug demonstrated a response rate of 28% on RBC-TI at 24 weeks and 13.6% at one year compared with 3.3% and 1.7%, respectively, for placebo. On the safety front, thrombocytopenia and neutropenia emerged as the most common Grade 3 or 4 adverse events (AEs), which were transient and manageable.Regulatory apprehensionsAhead of an advisory committee (adcom) meeting on Rytelo, FDA staff questioned the clinical significance and impact of the results, indicating that the data are “not supportive of a disease-modifying treatment effect” on overall survival or remission. They also expressed concerns about the higher frequency of Grade 3 or 4 AEs in the Rytelo group (91%) compared with the placebo group (47%). Lastly, the regulator remained doubtful about the applicability of IMerge’s findings to the US population since most participants were enrolled outside the country. However, at the subsequent adcom, the FDA panel voted by a margin of 12-2 in favour of the telomerase inhibitor’s clinical benefit/risk profile. Those voting against the recommendation opined that only a minority of patients would truly benefit from the therapy and the risks from increased toxicity far outweighed the benefits.At the time, Stifel Nicolaus analysts anticipated a 50/50 chance of Rytelo’s label carrying a boxed warning for haematological toxicity, but they suggested it would not be warranted because patients typically returned to normal or near-normal neutrophil and platelet levels after around three months of therapy, and no sequelae associated with the reduced cell counts were noted.Stiff competitionWithin the transfusion-dependent LR-MDS arena, Rytelo is poised to take on Bristol Myers Squibb’s Reblozyl (luspatercept-aamt), which was approved by the FDA last August. An expert interviewed by Firstword in March said despite Rytelo’s impressive ability to reduce the transfusion burden, it was likely to be superseded by Reblozyl in the MDS algorithm, owing to the latter’s low cytopenia risk. Last month, the Institute for Clinical and Economic Review (ICER) suggested that Rytelo’s annual price would need to be around $119,000 in order to make the therapy cost-effective for patients with MDS.

Drug ApprovalClinical ResultPhase 3OligonucleotideAccelerated Approval

07 Jun 2024

·www.biospace.com

FDA Approves Geron’s First-in-Class Telomerase Inhibitor for Blood Disorder

Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto Geron Corporation announced Friday the FDA has approved Rytelo (imetelstat) for patients with lower- to intermediate-risk myelodysplastic syndromes, a group of blood cancers caused by blood cells that are poorly formed or don’t function properly. Rytelo’s approval sent Geron’s stock surging more than 30% in Friday morning trading. Rytelo is approved for myelodysplastic syndromes (MDS) patients with transfusion-dependent anemia who do not respond or are ineligible for the standard-of-care treatment, erythropoiesis-stimulating agents (ESA). In addition to being first-in-its class, the treatment is also Geron’s first approved drug after 34 years in business. “For patients with lower-risk MDS and anemia who are transfusion dependent, we have very few options today and often cycle through available therapies, making the approval of Rytelo potentially practice changing for us,” Rami Komrokji, vice chair of the Malignant Hematology Department at Moffitt Cancer Center and an investigator in the pivotal IMerge trial, said in a statement. MDS is a group of blood cancers in which blood cells in the bone marrow do not mature or become healthy blood cells. In lower-risk MDS, it often progresses to require intense management of its key symptoms like anemia and can eventually cause organ dysfunction and heart complications. In the Phase III IMerge trial, patients on Rytelo had significantly higher rates of red blood cell transfusion independence (RBC-TI) over placebo for at least 24 weeks—28% in the treatment arm versus 3% on placebo. In these responders, RBC-TI was sustained for a median of 1.5 years. Administered every four weeks intravenously, Geron described the most common side effects of the drug as “manageable and short-lived" with Grade 3/4 adverse reactions of neutropenia (72%) and thrombocytopenia (65%) lasting a median of less than two weeks. In August 2023, Bristol Myers Squibb’s Reblozyl snagged a label expansion to position it as a first line treatment for anemia in patients with low-risk MDS with no prior ESA treatment. BMS’ molecule is an erythroid maturation agent that drives the production of red blood cells, minimizing the need for transfusion. When pitted against ESA treatments in a Phase III trial, 58.5% of patients on Reblozyl achieved RBC-TI that lasted at least 12 weeks, versus 31.2% for ESA-treated patients. GlobalData analysts project Reblozyl sales to reach $3.2 billion by 2029, while BMS has set its sights on $4 billion-plus aspirations for the drug. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Imetelstat

External Link

KEGG	Wiki	ATC	Drug Bank
D09629	Imetelstat	-	DB14909

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
myelodysplastic anemia	US	Geron Corp.	06 Jun 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Transfusion dependent anaemia	NDA/BLA	US	Geron Corp.	21 Jun 2023
Myelofibrosis	Phase 3	US	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	AR	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	AU	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	AT	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	BE	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	BR	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	BG	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	CO	Geron Corp.	12 Apr 2021
Myelofibrosis	Phase 3	DK	Geron Corp.	12 Apr 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02598661 (IMerge, ASCO2024)	Phase 2/3	-	-	Imetelstat 7.5 mg/kg	bviokbtfsc(fhueqtgdmv) = drxnrucrbn yzbllkfrwg (djvafxnzko ) View more	Positive	24 May 2024
				Placebo	bviokbtfsc(fhueqtgdmv) = gvykglnngp yzbllkfrwg (djvafxnzko )
NCT02598661 (IMERGE \| MDS3001, EHA2024) Manual	Phase 2/3	Myelodysplastic Syndromes	178	Imetelstat	rnjolcfkwx(oubamqfvhy) = gaydnnynem aztimapuoi (cpjbigeabc ) View more	Positive	14 May 2024
NCT02598661 (IMerge, Pubmed \| Lancet)	Phase 3	Myelodysplastic Syndromes ESA-relapsed \| ESA-refractory \| ESA-ineligible	178	Imetelstat 7.5 mg/kg	eakmkwkmbm(ixkpuhpcnl) = nolsnskjxr wmbsubjwxx (kstrgogseu, 30.9 - 49.3)	Positive	01 Jan 2024
				Placebo	eakmkwkmbm(ixkpuhpcnl) = zrpmxsrgcw wmbsubjwxx (kstrgogseu, 7.1 - 26.6)
NCT02598661 (IMerge, ASH2023)	Phase 3	Myelodysplastic Syndromes	178	Imetelstat	bxpekfxhhc(yiiamehdlz) = qumqchbiux fmrsgtheht (qqueapaoll ) View more	Positive	11 Dec 2023
				Placebo	bxpekfxhhc(yiiamehdlz) = lmikziyier fmrsgtheht (qqueapaoll ) View more
NCT02598661 (IMerge, ASH2023)	Phase 2/3	Refractory Myelodysplastic Syndrome \| Recurrent Myelodysplastic Syndrome	289	Imetelstat	hrarhrmjic(udxqmxmpnx) = lrymojndnf ejzawxviue (ycezfkqsfs ) View more	-	09 Dec 2023
				Placebo	hrarhrmjic(udxqmxmpnx) = eixrnxxkxv ejzawxviue (ycezfkqsfs ) View more
IMbark (Biospace) Manual	Phase 2	Refractory Myelofibrosis \| Recurrent Myelofibrosis	-	Imetelstat 9.4 mg/kg	cfwypnqbwh(mjugjkwzho) = sbawdbcuhg jmalwijpnb (rggllnxuba )	Positive	06 Dec 2023
NCT02598661 (MDS3001, EHA2023) Manual	Phase 3	Myelodysplastic Syndromes	178	imetelstat	vsaywovloj(etuqfityii) = hjkgxagnvw ryusloibvb (wqumdkqrbj, 30.93 - 49.25) Met View more	Positive	08 Jun 2023
				placebo	vsaywovloj(etuqfityii) = fpmbsxkfnc ryusloibvb (wqumdkqrbj, 7.10 - 26.57) Met View more
NCT02598661 (IMerge, ASCO2023) Manual	Phase 3	Myelodysplastic Syndromes	178	Imetelstat 7.5 mg/kg	ansebvhoqh(tjueljxyqf) = mmlqxwvwoa dqpoyrotaa (dqthvypuni ) View more	Positive	31 May 2023
				Placebo	ansebvhoqh(tjueljxyqf) = ukzbdzlrvi dqpoyrotaa (dqthvypuni ) View more
NCT02598661 (IMerge, Corporate Publications) Manual	Phase 3	Myelodysplastic Syndromes	178	imetelstat	yqitznfmdq(sshkmybvrx) = icppcwgfji gwzvtutqtl (jqcbdyvraq, 30.9 - 49.3) View more	Positive	04 Jan 2023
				Placebo	yqitznfmdq(sshkmybvrx) = acftgknhvy gwzvtutqtl (jqcbdyvraq, 7.1 - 26.6) View more
NCT02598661 (MDS3001, ASH2022) Manual	Phase 2/3	Myelodysplastic Syndromes	11	Imetelstat	zzyplehmhh(mvnwohvacc) = zixanudtig vkmhrnkcyd (cxytvrhtvi, 25.1 - 39.2) View more	Positive	15 Nov 2022

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