Cervical Intraepithelial Neoplasia News and Research

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Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL in males were published in the February 3 issue of the New England Journal of Medicine.

3 Feb 2011

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Program reduces cervical cancer deaths among HIV-infected women in Zambia

A new study undertaken in Zambia shows that, using setting-appropriate human resources and technology, morbidity and mortality from cervical cancer among HIV-infected women can be reduced. The study’s lead author is Dr Groesbeck Parham, Professor of Gynecologic Oncology and Infectious Diseases, University of Alabama at Birmingham, and Director of the Centre for Infectious Disease Research in Zambia’s Cervical Cancer Prevention Program. The research was published in the December issue of HIV Therapy.

14 Dec 2010

Gen-Probe's APTIMA HPV assay effective for cervical cancer screening: FASE study

In a study published today in the International Journal of Cancer, Gen-Probe's APTIMA HPV Assay provided a better combination of sensitivity and specificity than HPV DNA- or cytology-based tests for cervical cancer screening.

18 Nov 2010

Merck announces FDA Advisory Committee approval of GARDASIL for anal cancer and AIN treatment

Merck announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.

18 Nov 2010

Annual conventional Pap smear is cost effective to reduce cancer incidence and mortality

A study of the options for reducing cancer incidence and mortality among women who have been treated for precancerous cervical lesions found that an annual conventional Pap smear is a cost effective strategy.

21 Oct 2010

Inovio Pharmaceuticals achieves promising results in VGX-3100 Phase I study

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, its DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18.

13 Sep 2010

Advaxis completes enrollment of vanguard patient group in phase II clinical trial for cervical intraepithelial neoplasia

Advaxis, Inc.,, the live, attenuated Listeria monocytogenes (Lm) biotechnology company, enrolled and has administered its initial dose to its third patient in its US Food and Drug Administration (FDA)-approved, phase II clinical trial in cervical intraepithelial neoplasia (CIN), commonly known as cervical dysplasia.

24 Jun 2010

Advaxis doses first patient in FDA-approved phase II CIN trial

Advaxis, Inc., the live, attenuated Listeria monocytogenes biotechnology company, has dosed the first patient in its US Food and Drug Administration -approved, phase II clinical trial in cervical intraepithelial neoplasia, commonly known as cervical dysplasia.

28 May 2010

Advaxis initiates Phase 2 clinical trial of ADXS11-001 for treatment of CIN

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, initiated the Company's first clinical trial site in its randomized, single blind, placebo-controlled, Phase 2 clinical trial of ADXS11-001 for the treatment of cervical intraepithelial neoplasia.

16 Apr 2010

Enrollment completes for Inovio Biomedical's dose escalation phase I trial of cervical cancer vaccine

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that the company has completed enrollment of all subjects for its therapeutic cervical cancer vaccine (VGX-3100) phase I trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18, and is delivered via in vivo electroporation.

8 Apr 2010

Health Canada approves GARDASIL for prevention of genital warts in males

Today, Merck announced that Health Canada has approved GARDASIL(R) (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine) for boys and men nine through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.

23 Feb 2010

HPV DNA testing vital in identification of cervical cancer

Roche Molecular Systems, Inc. announced today that preliminary data from its ATHENA (Addressing THE Need for Advanced HPV Diagnostics) trial support the importance of screening for human papillomavirus (HPV) genotypes that put women at highest risk for developing cervical cancer. ATHENA is a prospective, double-blind, multi-centered, 47,000-patient, U.S.-registration trial designed to demonstrate the effectiveness of HPV detection as part of a cervical cancer screening program.

18 Feb 2010

Phase III data reveals potential of Merck’s GARDASIL in preventing HPV and HPV-related cancers

Merck & Co., Inc. announced today that in new Phase III data, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] was 77.5 percent (95 percent CI: 39.6, 93.3) efficacious against anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in 16-to-26 year-old men who have sex with men. The data were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) conference in Monte Carlo, Monaco.

18 Feb 2010

Overall benefits of HPV vaccination or frequent screening are low for women over 41

The overall potential benefits of human papillomavirus (HPV) vaccinations or frequent HPV screenings for women over the age of 41 are low, concludes a new study published online February 15 in the Journal of the National Cancer Institute. The study found that the rate of new infections preventable by vaccination declines with age. Furthermore, new infections among women at any age typically do not progress to cervical intraepithelial neoplasia grade 2 (CIN 2) or CIN 3, the precursors for cervical cancer.

16 Feb 2010

Positive interim results from Helix BioPharma's Topical Interferon Alpha-2b Phase II pharmacokinetic study

Helix BioPharma Corp. today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.

14 Feb 2010

Advaxi to receive fund from CRUK for clinical trial of ADXS11-001

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.

10 Feb 2010

Inovio Biomedical announces additional immunogenicity data from therapeutic cervical cancer vaccine trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today additional interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

8 Feb 2010

HPV vaccination programs may reduce genital diseases

High-coverage human papillomavirus (HPV) vaccinations among adolescents and young women may result in a rapid reduction of genital warts, cervical cell abnormalities, and diagnostic and therapeutic procedures, researchers report in a new study published online February 5 in the Journal of the National Cancer Institute. Some of these genital abnormalities are precursors of cervical, vulvar, and vaginal cancers.

6 Feb 2010

USPTO issues new patent for Advaxis' intellectual property portfolio

The U.S. Patent and Trademark Office (USPTO) issued today patent 7,635,479, "Compositions and Methods for Enhancing the Immunogenicity of Antigens,” by Dr. Yvonne Paterson, et al, which is assigned to the Trustees of the University of Pennsylvania and licensed to Advaxis, Incorporated (OTCBB: ADXS).

22 Jan 2010