A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

开始日期2006-10-01

申办/合作机构

Vical, Inc.

NCT00044356

/ Completed临床2期

A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma

The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

开始日期2001-02-01

申办/合作机构

Vical, Inc.

NCT00003646

/ Completed临床2期

Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

开始日期1998-08-01

申办/合作机构

Vical, Inc.

100 项与 Velimogene aliplasmid 相关的临床结果

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100 项与 Velimogene aliplasmid 相关的转化医学

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100 项与 Velimogene aliplasmid 相关的专利（医药）

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项与 Velimogene aliplasmid 相关的文献（医药）

2017-08-01·Melanoma research4区 · 医学

Successful treatment with imatinib after nilotinib and ipilimumab in a c-kit-mutated advanced melanoma patient: a case report

4区 · 医学

Article

作者: Simone M. Goldinger ; Reinhard Dummer ; Lars E. French ; Pascale Kränzlin-Stieger ; Carla Murer

Treatment of melanoma remains a challenge in advanced disease. Recently, the molecular differentiation in BRAF-mutated, NRAS-mutated and c-kit-mutated melanomas led to new treatment strategies. Different trials show that imatinib or nilotinib lead to meaningful responses in c-kit-mutated melanoma patients. There are little published data on sequential inhibition using these two drugs in melanoma. We describe the sequential use of imatinib after nilotinib in a c-kit-mutated melanoma patient, who progressed on interferon, Allovectin, dacarbazine, nilotinib and ipilimumab, and was finally treated with the c-kit inhibitor imatinib. From July 2011 to September 2011, the patient received ipilimumab (four doses with 3 mg/kg). Clinical assessment after immunotherapy showed disease progression. Therefore, a treatment change to imatinib 800 mg daily was made from February 2012 to May 2013. Under this treatment, the patient showed a partial response as per the RECIST criteria. The present lesions continued responding (computed tomography scans: May 2012–March 2013). Unfortunately, in October 2012, new brain metastases developed. Nevertheless, the use of c-kit inhibitors in c-kit-mutated melanoma patients seems to be a promising treatment option. Furthermore, a delayed response to ipilimumab after 6 months could also have led to or supported the partial response in this case. However, when two biologically similar compounds are administered in a melanoma patient and the tumour mass shows progressive disease upon administration of the first agent, an additional progression with no effect may be expected when the second one is used. This case shows, in contrast, that the use of imatinib after progression upon nilotinib can be beneficial.

2015-03-01·Current opinion in oncology3区 · 医学

Intralesional therapy for advanced melanoma

3区 · 医学

Review

作者: Agarwala, Sanjiv S

PURPOSE OF REVIEW:

Patients with unresectable, multiple or advanced locally/regionally metastatic stage IIIB/C or stage IV M1a melanoma have a high risk for recurrence, progression and metastasis. The article reviews treatment advances for this population.

RECENT FINDINGS:

After promising phase 2 results with Allovectin-7 (velimogene aliplasmid), overall survival in a phase 3 study was shorter for Allovectin-7 than for dacarbazine/temozolomide (median 18.8 versus 24.1 months).In a phase 2 trial of intratumoral electroporation of plasmid interleukin-12 among 28 patients with advanced melanoma, the primary endpoint of best overall response rate within 24 weeks of first treatment was 32.2% for objective response and 10.7% for complete response.In the phase 3 OPTiM trial of talimogene laherparepvec, the intralesional agent that is furthest along in clinical testing, the primary endpoint of durable response rate was 16% for talimogene laherparepvec and 2% for granulocyte macrophage colony-stimulating factor.In the PV-10 phase 2 trial among 80 patients with stage III-IV melanoma, the overall response rate was 51%, with a 26% complete response rate.

SUMMARY:

Despite advances, many patients will need several lines of therapy. Some will not be eligible for systemic therapy. Their low toxicity, easy administration and likely systemic immune effects make intralesional therapies an attractive option.

2013-10-01·Clinical cancer research : an official journal of the American Association for Cancer Research

A Sea Change in Melanoma

Article

作者: Bates, Susan E.

As this issue of Clinical Cancer Research goes to press, Vical, Inc., a pharmaceutical company developing an intralesional gene therapy for melanoma, Allovectin-7, announced its decision to discontinue development following negative results in a phase III trial (1). This story highlights the sea change that has occurred in therapy for metastatic melanoma. The phase III pivotal trial, which launched in 2006 (NCT00395070), compared Allovectin-7 to standard therapy—dacarbazine or temozolomide (2). The pivotal trial followed a phase II study in which an 11.8% response rate was observed, with durability for responding patients, yet a median time to progression of 1.6 months (3). These results, which were at that time sufficient to launch a pivotal trial in an era defined by negative phase III trials, contrast sharply with the 48% response rate for vemurafenib and 52% for dabrafenib in pivotal trials, with progression-free survivals of 5.3 and 5.1 months, respectively (4). Allovectin-7 represented a novel therapy with modest activity that might have received U.S. Food and Drug Administration approval a decade ago on the basis of durable responses alone, but in the wake of new drug approvals, expectations about therapy for melanoma have changed dramatically. We can only hope for such a sea change in other solid tumors. This edition of CCR Focus highlights the progress in our molecular understanding of melanoma, discusses the new agents that have raised the bar on efficacy, and reviews the challenges facing the field in combining the new strategies. With Guest Editors Keith Flaherty and Patricia LoRusso, the articles in this CCR Focus section discuss new molecular targets in melanoma, targeted therapy, the new immune checkpoint inhibitors, and adoptive cell transfer immunotherapy. As with every edition of CCR Focus, we hope to inform those interested but not expert in the field and to challenge those working in the field.Susan E. BatesDeputy Editor, CCR FocusNational Cancer Institute

项与 Velimogene aliplasmid 相关的新闻（医药）

2017-01-20

·BioSpace

New FDA Report Cites 22 Drugs That Passed Phase II But Crashed and Burned in Phase III

January 20, 2017 By Mark Terry , BioSpace.com Breaking News Staff The Trump administration has indicated plans to reform the U.S. Food and Drug Administration (FDA) “to put greater focus on the need of patients for new and innovative medical products.” So far, it hasn’t selected a commissioner for the FDA, although some of the names suggested, such as Jim O’Neil , a venture capitalist, and Balaji Srinivasan , co-founder of genetics testing company Counsyl , have showed indications that they want to focus on drug safety rather than efficacy, perhaps even cutting the need for in-depth Phase III clinical trials. The FDA just published a study titled, “22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results .” Below are the so-called Hall of Shame drugs that showed promise in Phase II, but failed in Phase III. 1. Bitopertin ( Roche , . For schizophrenia. Failed to improve the negative symptoms of schizophrenia. 2. Bitopertin ( Bristol-Myers Squibb , . For hepatocellular cancer. Failed to improve overall patient survival compared to approved treatment and had unexpected toxicities. 3. Capsaicin Topical Patch, Qutenza ( NeurogesX , ). To treat HIV-associated nerve pain, with previous approval for treatment of shingles-associated nerve pain. Lack of efficacy compared to control groups. 4. Darapladib ( GlaxoSmithKline , .) As an add-on to statins for cardiovascular disease in patients with a prior heart attack. Failed for lack of efficacy, despite promising biomarker evidence in Phase II. 5. Dexmecamylamine ( Targacept , / AstraZeneca , . For add-on treatment of depression. No more effective than placebo in Phase III trials for treatment of depression. 6. Exhale Drug-Eluting Stent ( Broncus Technologies ). For reduction of shortness of breath in emphysema patients. Statistically significant results in Phase II, but failed to improve lung function or symptoms in Phase III. 7. Experimental HSV-2 Vaccine ( Chiron , now Novartis Vaccines & Diagnostics ). To prevent genital herpes. Positive biomarker results in Phase II, did not prevent genital herpes in Phase III. 8. Gluatmic Acid Decarboxylase Vaccine ( Diamyd Medical ). For the preservation of insulin secretion for patients with recent-onset type 1 diabetes. Promising results in Phase II, but in the Phase III trial, did not improve pancreatic function or clinical outcomes. 9. Imiquimod, Aldara 5% Cream ( 3M , . To treat molluscum contagiosum (MC) lesions in children. Was approved to treat external anogenital warts. Showed promising Phase II results, but in Phase III did no better than placebo. 10. Iniparib ( Sanofi , . As an add-on treatment of triple negative breast cancers. Showed promising tumor response and survival in Phase II, but in Phase III did not improve survival. 11. Lithium ( King’s College London , UK). Already a treatment for bipolar disorders, was being tested as an add-on treatment to delay disease progression of amyotrophic lateral sclerosis. Showed positive effects on disease progression and survival in Phase II, but in Phase III did not improve survival, health status or quality of life. 12. MAGE-A3 Vaccine ( GlaxoSmithKline , . For non-small cell lung cancer (NSCLC). Proof of concept trial was promising, but showed no clinical benefit compared to placebo in Phase III. 13. NicVAX Vaccine ( Nabi Biopharmaceuticals , . For smoking cessation. Promising Phase II, but in Phase III the abstinence rate was similar to placebo. 14. Velimogene Aliplasmid, Allovectin-7 ( Vical , . For metastatic melanoma. In Phase II, showed evidence of tumor shrinkage. In Phase III, reduced tumor size in significantly fewer patients than two other marketed drugs. 15. Olanzapine Pamoate, Zyprexa Relprevv ( Eli Lilly , . Evaluated for long-acting injection treatment for schizophrenia. Already approved as an oral short-acting treatment for schizophrenia. In Phase III, identified serious safety risks. 16. Aliskiren, Rasilez, Tekturna ( Novartis , . Evaluated as an add-on treatment for prevention of congestive heart failure (CHF) complications. Previously approved for hypertension. Positive results in an proof of concept study, but in the Phase III trial adding aliskirin to standard therapy, did not cut cardiovascular-related death or CHF re-hospitalization, and showed an increase in kidney failure and low blood pressure. 17. CoStar Drug-Eluting Stent ( Conor Medsystems ). To cut heart attack risk in patients with coronary artery disease. Although approved in Europe and had positive results in a small trial, patients who received it in Phase III trials had worse outcomes than those receiving different stents. 18. Figitumumab ( Pfizer , . Evaluated as an add-on treatment of advanced non-small cell lung cancer (NSCLC). Showed promise in Phase II, but in Phase III failed to improve survival. Also, in one combination with another regimen, increased serious adverse events and deaths. 19. Recombinant Factor VIIa, NovoSeven ( Novo Nordisk , . Evaluated for decrease of intracerebral bleeding and hematoma size in stroke patients. Already approved for hemophilia. Showed positive Phase II results, but in Phase III, patients didn’t show clinical benefits, but did have an increase incidence of serious events compared to patients receiving the placebo. 20. Semagacestat ( Eli Lilly , . For Alzheimer’s disease. Showed promising biomarker results in Phase II, but the Phase III trial was ended early because patients receiving the drug had worsened cognition, worse functional status, and an increased risk of skin cancer. 21. Torcetrapib ( Pfizer , . For the prevention of cardiovascular events in patients with a history of cardiovascular disease or type 2 diabetes. Showed improved cholesterol levels in Phase II trials, but in Phase III it increased mortality and cardiac events compared with placebo. 22. V710 Vaccine (Intercell--now Valneva / Merck , . V710 Vaccine (Intercell (now Valneva)/Merck, MRK). Evaluated as a vaccine to prevent Staphylococcus aureus infection. Showed promise in Phase II, but the Phase III clinical trial was ended early because of lack of efficacy and the potential risk for serious adverse events and death. John Carroll , writing for Endpoints News, writes , “Some on the libertarian side have said they want to simply toss out the gold standard on efficacy and safety altogether, excoriating the old rules of market engagement. That toxic argument raises some important questions about each stage of drug development. And there’s a new report out from the FDA that covers just what you can miss if you cut Phase III out altogether.”

临床结果临床3期临床2期疫苗上市批准

2015-06-23

·BioSpace

Vical Herpes Vaccine Clinical Trial Disappoints with “Confounding Results”

June 23, 2015 By Mark Terry , BioSpace.com Breaking News Staff The NASDAQ temporarily halted sale of San Diego-based Vical stock yesterday in anticipation of news regarding its Phase I/II clinical trial for a genital herpes vaccine. Unfortunately, the trial did not meet either of its primary endpoints and trading resumed with a major drop in share prices. The trial was conducted across seven sites in the U.S. and had two goals, to test a monovalent (gD) vaccine and a bivalent (gD + UL46) vaccine utilizing Vical ’s proprietary Vaxfectin adjuvant. An adjuvant is a molecule added to a drug or therapy or vaccine that is designed to enhance the body’s immune response. The study’s primary endpoint was a change in viral shedding rate and genital herpes lesions in herpes simplex virus type 2 (HSV-2) patients. Neither of the study’s primary endpoints were met. “We just received the top-line study data and we are disappointed that the vaccines did not meet the primary endpoint,” said Vijay Samant , president and chief executive officer of Vical in a statement. “The trial is ongoing and all patients are being followed for safety for 12 months and efficacy for nine months after their final vaccine dose. During that nine-month period, we will collect additional clinical efficacy data including recurrence rate and lesion rate, which will enable us to determine the appropriate next steps for this program. We greatly appreciate the ongoing support of the patients and investigators who are taking part in this trial.” Not surprisingly, Vical stock took a hit. Prior to the news, shares traded for $1.42 per share. After the news, shares sold for $0.73. Only recently had the shares been selling that high. For the last year stock was trading somewhat unevenly, but on a slightly downward trend. Shares traded for $1.30 on July 29, 2014, dropped to $1.00 on Jan. 7, 2015, rose to $1.17 on Jan. 14, 2015, dropped again to $0.85 on Mar. 26, 2015 and traded for $0.98 on June 6, 2015. The company is not new to failed vaccine trials. On Aug. 12, 2013, Vical announced top-line results from a Phase III trial of Allovectin, an intratumoral cancer immunotherapy in patients with metastatic melanoma. In that 390-patient trial, primary endpoints were not met in a study that examined the vaccine’s effectiveness compared to first-line chemotherapy. It failed, as well, to meet secondary efficacy endpoints. As a result, the company shifted its focus to infectious disease vaccines. In response to its failed herpes vaccine trial, the company indicated it would continue its focus on its CMV (cytomegalovirus) vaccine candidate in partnership with Astrellas . “Enrollment is complete in the Phase II solid organ transplant trial, placing us on track for data during the second half of 2016, and the Phase III pivotal trial is underway in hematopoietic stem cell transplant recipients,” said Samant in a statement. “We are also moving our in-licensed antifungal compound toward a Phase I trial initiation during the first half of 2016. Because Astellas funds the CMV program and given the other operational efficiencies we have put in place, we anticipate that our current cash flow position will fund us through these milestones and into 2017.” Further complicating the herpes study was the unexpected evidence of greater viral shedding in the placebo group, evidence that the company admits they don’t yet understand. “The placebo group offered confounding results,” said Astrellas Mammen “ Anza ” Mammen , vice president of Vical clinical vaccines in yesterday’s conference call “The placebo used in this trial is a phosphate buffered saline, PBS, which should not have any biological activity. This group was primarily included as a safety comparison and therefore was designed to be small, with just 21 patients. The study was not designed to compare the placebo and vaccine arm. But the fact is, the placebo group had a higher shedding rate of 18.4 percen compared to less than 15 percent in each of the vaccine arms.” Further analysis as more data comes in will be necessary. As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be? Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo. Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo , a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK) . So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "as-rumors-swirl-about-glaxo-bid-who-could-suitors-be", placeholder: "pd_1434950261" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));

疫苗临床2期临床结果临床3期免疫疗法

2007-12-05

·BioSpace

John Wayne Cancer Institute: Allovectin-7® May Offer Patients a New Option for Advanced Melanoma

SANTA MONICA, Calif.--(BUSINESS WIRE)--Skin cancer specialists at The John Wayne Cancer Institute at Saint John’s Health Center are recruiting patients into a large Phase 3 study to evaluate the safety and effectiveness of Allovectin-7®, an investigational product for advanced melanoma. If Allovectin-7® is found to be safe and effective in clinical trials, it may offer patients a new option for fighting advanced melanoma (stage 3 or stage 4). Safety and efficacy data from a Phase 2 clinical trial of Allovectin-7® were presented at the 2006 American Society of Clinical Oncology (ASCO) meeting. The ongoing Phase 3 study is designed to determine whether more patients with advanced melanoma respond favorably to Allovectin-7® alone than to current standard chemotherapy alone. To find out whether you or someone you know qualifies for the study, please visit

ASCO会议

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外链

KEGG	Wiki	ATC	Drug Bank
D09030	-	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
头颈部鳞状细胞癌	临床3期	美国	Vical, Inc.	2002-12-09
口咽部鳞状细胞癌	临床3期	美国	Vical, Inc.	2002-12-09
复发性黑色素瘤	临床3期	美国	Vical, Inc.	1998-07-01
转移性黑色素瘤	临床3期	美国	Vical, Inc.	1998-07-01

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2012	临床2期	转移性黑色素瘤	127	velimogene aliplasmid (Clinical Benefit (CB))	範鬱願壓膚願齋遞窪淵(顧顧繭製鏇築衊網觸顧) = 獵憲獵積窪鬱構願獵鑰窪遞鹽鏇鹹壓構選糧構 (醖鏇廠襯獵簾壓鹽鑰蓋, 6.2 ~ 17.4) 更多	-	2012-05-20
ASCO2012	临床2期	转移性黑色素瘤	127	velimogene aliplasmid (Progressive Disease (PD))	選夢鏇願獵鹹齋鑰鹹鑰(繭觸壓糧鏇夢鹽齋壓醖) = 顧選壓觸鬱鏇鏇構鑰願窪遞醖糧構鹹積鏇鏇遞 (鏇顧醖觸選鏇遞積繭齋 )	-	2012-05-20
ASCO2011	临床2/3期	黑色素瘤	-	Allovectin 2 mg	衊繭艱襯齋遞構醖壓鹽(淵構淵艱顧積餘願鬱繭) = 構鏇艱願糧積衊憲鏇糧糧構壓齋餘鬱鑰築顧獵 (憲淵簾餘願築顧製壓繭 ) 更多	积极	2011-05-20
ASCO2005	临床2期	转移性黑色素瘤	133	Allovectin-7	夢鑰鹹構壓選觸鹹衊網(糧製積壓鹹網醖繭廠襯) = 蓋醖繭簾醖製鑰製鏇鏇醖淵鏇網窪構築膚襯夢 (艱築淵衊艱糧積顧鏇艱, 8.3 ~ ongoing) 更多	-	2005-06-01
ASCO2004	临床2期	转移性黑色素瘤	133	Allovectin-7	範網淵範夢積窪簾積簾(艱繭齋獵積衊鹽製積鑰) = One Grade 3 adverse event associated with A-7 have been reported 廠憲繭衊鹽製簾鹹願蓋 (鏇鑰淵構衊顧選膚範網 ) 更多	-	2004-07-15