Treatment for HPV...?

[Bent_Bladi]

New HPV vaccine hits the shelves

By Shelley Shan
STAFF REPORTER
Wednesday, Dec 20, 2006

A new vaccine aimed at preventing cervical cancer and other diseases caused by the human papillomavirus (HPV) was launched yesterday and is now available in all medical institutions.

Individuals who want to be vaccinated must pay for it out of their own pocket, as the National Health Insurance does not cover the vaccine.

Lai Hung-Cheng, a doctor of obstetrics and gynecology at the Tri-Service General Hospital, said yesterday that the vaccine would not cure patients with cervical cancer nor replace the pap smear.

Rather, it is used to lower the risk for women of developing cervical cancer.

"In general, individuals who started having sexual intercourse at an early age and frequently are encouraged to get the vaccine as soon as possible," Lai said.

The vaccine can lower the chance of developing cervical cancer by 70 percent, he added.

The vaccine, named Gardasil, is a quadrivalent HPV recombinant vaccine.

Gardasil was developed by Merck, Sharp and Dohme to treat diseases induced by four different types of HPVs. These diseases include cervical cancer and genital warts.

The Department of Health has only approved the use of the vaccine for women between the ages of nine and 26.

Individuals who do not belong to this age category are advised to consult a doctor before receiving the vaccine, as it will be considered an "off-label use of vaccine."

The vaccine must be administered three times and the entire process must be completed within a period of three months.

No screening for HPV is necessary before the injection.

[Bent_Bladi]

Require HPV vaccine for students
December 21, 2006

In the wee hours of the Legislature's last day in session, a bill that would have helped protect girls and women from deadly disease died due to lack of information. A measure to make the HPV vaccine more readily available should be reconsidered early next year - and enacted.

The FDA this spring approved a vaccine against four strains of the human papillomavirus that cause up to 70% of cervical cancer cases. The vaccine is most effective when it's given to girls before they become sexually active and is generally recommended around age 11 or 12. The HPV vaccine doesn't give girls a license to go forth and fornicate, it just means that they shouldn't get cancer if they do have sex at any time before they are married - which 9 out of 10 people do, according to a new study.

Putting the vaccine on the required list for school - with parents able to opt in or out for their daughters - gets it to more people and gets it covered by insurance.

Some lawmakers balked at legislation they said would encourage sexual activity. But the biggest last-minute holdup was that too many of the decision-makers knew too little about the drug, and recent cases of FDA-approved medications turning out to be dangers made others uneasy. Solid answers were elusive as the session dragged on past midnight.

The Centers for Disease Control and Prevention, with a strong tradition of protecting the American public, deems the vaccination safe based on tests on thousands of women around the world. Lawmakers should get the information they need to ease their concerns and put this vaccination on the school list.

[Bent_Bladi]

Of course, for me, prevention is better than wasting mallayeen il dollaraat trying to find a cure (or vaccine).

[Al-khiyal]

Mardi 20 Mars 2007 -- Deuxième maladie répandue chez la femme, après le cancer du sein, celui du col de l’utérus enregistre 1 200 nouveaux cas chaque année en Algérie. Si la détection de la maladie intervient souvent à un stade avancé de la pathologie, la prévention contre le virus HPV doit cependant intervenir à un âge précoce chez la femme.

Lors d’un symposium organisé, hier, par les laboratoires GSK, des spécialistes en cancérologie et en pathologie ont débattu de l’âge auquel devrait avoir lieu la vaccination contre le virus HPV. Car, faut-il le préciser, la nécessité et l’obligation d’introduire ce vaccin ne sont plus à démontrer. Le ministère de la Santé, de la Population et de la Réforme hospitalière (MSPRH) a présenté, il y a dix mois, son programme national de lutte contre le cancer en annonçant l’ouverture de huit centres de lutte contre cette maladie. Des campagnes de sensibilisation et de prévention contre le cancer du col de l’utérus sont également inscrites en priorité de ce programme. Le dépistage par mammographie de cette maladie devrait être lancé à partir de cette année.

Premier laboratoire en Europe à avoir l’autorisation de fabrication du vaccin contre le HPV, le groupe GSK a présenté aux spécialistes ce produit, que l’Algérie doit, désormais, inscrire sur sa nomenclature. Le groupe français n’écarte pas d’ailleurs la possibilité d’ouvrir, dès les prochains mois, une unité de fabrication de ce vaccin en Algérie. Pour le moment, le MSPRH prévoit d’organiser un consensus pour définir l’âge à partir duquel sera appliquée la vaccination, qui doit être fixé pour les fillettes entre 11 et 15 ans. Selon les spécialistes rencontrés lors de ce séminaire, la vaccination reste le seul moyen pour prévenir contre le virus HPV, sachant que les facteurs de risque restent encore méconnus. Le cancer du col de l’utérus est considéré comme «maladie tranquille, qui se développe très lentement mais qui ne se manifeste qu’à un stade très avancé». D’où l’importance du dépistage et de la vaccination.

Cancer du col de l’utérus : La vaccination des fillettes entre 11 et 15 ans est obligatoire

[Al-khiyal]

A campaign fronted by doctors and celebrities to persuade European governments, including the UK, to vaccinate all young girls against cervical cancer is being entirely funded by the drug company that markets the vaccine.

Sanofi Pasteur MSD, which markets Gardasil in Europe on behalf of the drug giant Merck, spent millions on what was billed as the "first global summit against cervical cancer", held in Paris on Thursday with doctors and patient organisations from across Europe.

The revelation comes as public health experts express disquiet about the promotion of a vaccine that is only effective in young girls - possibly at the expense of screening programmes that are essential to protect adults. They also worry that the long-term effects of the vaccine are not known. The vaccine protects against the most common strains of the sexually-transmitted human papilloma virus (HPV) which causes cervical cancer.

Diane Harper, a professor at Dartmouth medical school in New Hampshire, who led two vaccine trials, said the vaccine would not protect against all strains of the virus, and that nobody knows whether vaccinated 10-year-old girls would still be protected in 10 years' time, when they are sexually active and at risk. Mass vaccination programmes, she said, would be "a great big public health experiment".

The Paris summit was believed to be the brainchild of Professor David Khayat, a Paris-based specialist in cancer treatment - not vaccines - who has in the past declared consultancy and lecture fees from Merck. The organisers were named as the Club Européen de la Santé, an institution that promotes public health, but its president, Dominique Dupont, told the Guardian she agreed to participate only on condition that Sanofi Pasteur paid.

Celebrities, doctors and journalists were shipped in from across Europe and the United States by PR agencies working for Sanofi. The summit, which resembled a political rally, called for country-wide vaccination programmes.

Vaccination campaign funded by drug firm

[NinaGucci]

Basel, 11 April 2007

Roche and Transgene enter partnership on therapeutic vaccines against HPV-mediated diseases
Roche to develop and commercialize products from Transgene’s programme

Roche and Transgene announced today that they have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene’s therapeutic vaccine program against Human Papilloma Virus-mediated diseases. The Human Papilloma Virus (HPV) is associated with the development of precancerous lesions and cancer of the cervix. The agreement includes Transgene’s lead therapeutic vaccine candidate TG 4001 (MVA-HPV-IL2), currently in clinical development to treat high grade cervical intraepithelial neoplasia (CIN2/3), a precancerous cervical abnormality which can lead to cervical cancer. Under the agreement, Roche will lead worldwide development and commercialization. TG 4001 has completed Phase II studies and is in planning for entry into Phase III studies.

‘Transgene is an ideal strategic fit for Roche, offering a differentiated approach to a precancerous condition with high unmet need,’ said Peter Hug, Roche’s Global Head of Pharma Partnering. ‘Transgene’s expertise in viral vaccine therapeutics complements our core capabilities in oncology and virology drug development. In addition, as Roche is a leader in in vitro diagnostics with strong capabilities in HPV detection, our collaboration with Transgene has the potential to expand and evolve into an integrated personalized medicine approach. We look forward to working with Transgene on this program.’

‘We are delighted by Roche’s commitment to further develop our promising vaccine TG 4001 in the field of HPV-mediated diseases,’ said Philippe Archinard, Chief Executive Officer of Transgene. ‘Roche has broad expertise and a leadership position in the development and marketing of first-in-class innovative therapies. This first strategic partnership is an acknowledgement of the validity of our technology and strategy. It is a considerable transforming event for Transgene that we anticipate will enable us to accelerate and broaden the development of our entire product portfolio.’

Terms of the Agreement
Roche will acquire an exclusive license for TG 4001 and further therapeutic vaccine development candidates resulting from the collaboration in HPV-mediated diseases, and will have exclusive worldwide commercialization rights. Roche will fund all future costs associated with the development of TG 4001 and will lead the Phase III studies.

Transgene will receive 13 million Euros as an upfront payment and 10 million Euros as a near-term regulatory milestone payment related to planning the Phase III studies. Roche may pay Transgene up to 195 million Euros, upon the achievement of certain further development and sales-based events in various HPV-related indications. Transgene is also entitled to double-digit escalating royalties on sales once a product is marketed.

Roche will hold all manufacturing rights but has agreed to allocate, on commercial terms, exclusive responsibility to Transgene for the clinical-trial supply of TG 4001 and additional HPV products, which may be developed in the future. This agreement will be extended to commercial-supply manufacturing for an initial period.

About TG 4001
TG 4001 therapeutic vaccine is designed to target HPV type 16 (HPV16), known to be a high risk factor for the development of precancerous cervical intraepithelial neoplasia and subsequently cervical cancer.

TG 4001 (MVA-HPV-IL2) is based on a non-propagative, highly attenuated vaccinia vector (MVA), which is engineered to express HPV16 antigens and an adjuvant. As an immunotherapy for women diagnosed with diseases caused by the HPV 16 infection, TG 4001 is designed to have a two-pronged anti-viral approach: to alert the immune system specifically to HPV16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through an adjuvant (interleukin 2).

In Phase II clinical trials, TG 4001 demonstrated safety and promising clinical responses and efficacy in women with HPV16 CIN2/3. Results of a trial in France, announced last year, of 21 women with HPV16 CIN 2/3, showed promise as 10 women no longer had detectable levels of CIN2/3 six months after vaccination (disappearance of the precancerous lesions and no detectable HPV16 E6 / E7 mRNA). No serious side effects were observed. Sustainability of the response was assessed by an examination at Month 12 of the patients who did not undergo surgical excision of CIN lesions at Month 6. No CIN2/3 relapse nor any HPV16 persistence or re-infection were observed in these women. A placebo-controlled Phase III program is in planning to enrol an estimated 500 patients with CIN2/3 caused by HPV16.

About HPV-mediated diseases
HPV infection is recognized as the necessary cause of precancerous cervical lesions and cervical cancers and is the most common sexually transmitted disease affecting about 400 million women worldwide. Most infections are spontaneously eliminated in less than one year. In the remaining cases, persistent HPV infection can lead, after several years or decades, to precancerous lesions of the cervix - called cervical intraepithelial neoplasia of grades 2 and 3 (CIN 2/3) - and eventually to cervical cancer. Worldwide, new cases are reported at a yearly rate of around 1.4 million for CIN 2/3 and 500,000 for cervical cancer, of which approximately 50% are linked to HPV16. The HPV16 genotype, along with HPV18, 31 and 33 genotypes, have the highest risk of transforming infected cervical cells into cancerous cells.

Due to the wider use of HPV testing, HPV infection is being diagnosed in an increasing number of women, but no anti-viral treatment is currently available. Surgical resection, currently the only therapeutic solution, is highly effective but presents medical complications and relapses. Therefore, a therapeutic vaccine to clear precancerous lesions and the associated HPV infection could be an effective, non-invasive approach for the prevention of cervical cancer.

Roche launched the Amplicor HPV Test and the Linear Array HPV Genotyping Test in Europe in 2004 and 2005 respectively. Both tests are currently under review by the US Food & Drug Administration (FDA) for approval to market the tests in the United States. The Amplicor HPV Test is designed to enable accurate detection of 13 high-risk HPV genotypes (including HPV16) in standard clinical samples. The Linear Array HPV Genotyping Test is designed to identify which of 13 high-risk HPV genotypes are present in a sample. Studies worldwide have used the research prototype of the Roche Diagnostics Linear Array HPV Test to better understand HPV.

About Transgene
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has three compounds in Phase II trials and one compound in Phase I studies. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at Transgene.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the global leader in biotechnology, Roche contributes on a broad range of fronts to improving people’s health and quality of life by supplying innovative products and services for the early detection, prevention, diagnosis and treatment of diseases. Roche is the world leader in in-vitro diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. It is also engaged in other important therapeutic areas including autoimmune, inflammatory and metabolic disease and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at Welcome to Roche.

Roche - Media News

[Bent_Bladi]

I love reading about how vaccines are made/how they work. I just went to a seminar today that talked about new developments for TB vaccinations -- the best hour of my life

thanks nina