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Resolvyx Initiates Phase I Clinical Trial Of Novel Resolvin, RX-10001, For Asthma And Inflammatory Diseases
Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced that it has initiated the first human clinical trial evaluating an oral resolvin therapeutic, RX-10001, in a Phase I clinical trial in healthy volunteers. RX-10001 is a synthetic form of RvE1, a naturally occurring resolvin, which in animal studies has been shown to activate the body"s own off-switch mechanisms for inflammation and to promote healing for normal tissue function. In preclinical testing, RX-10001 and analogs have shown high potency across a range of inflammatory disease models, including asthma, colitis, rheumatoid arthritis, and atherosclerosis.
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The United Nations To Launch "Texting4Health" In Uganda
The UN is launching, on Wednesday the 1st of July 2009, a ten-day initiative intended to reach out to 10,000
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Denver Post Examines Efforts To Establish Needle-Exchange Programs In Colorado
The Denver Post on Friday examined efforts to establish needle-exchange programs in Colorado to reduce the risk of HIV and hepatitis C among injection drug users. According to the Post, 185 cities in Colorado have needle-exchange programs, but legislation that would have legalized needle exchanges statewide did not advance in the Legislature this year. "The issue is more complex than it perhaps first appears," Evan Dreyer, a spokesperson for Gov. Bill Ritter (D), said, adding that "law enforcement and the Colorado Department of Public Health and Environment both expressed serious reservations" about a proposal that would have legalized needle-exchanges statewide. A coalition of public health officials, treatment providers and advocates are increasing efforts to establish a needle-exchange program in Denver, the Post reports. The Denver Drug Strategy Commission in February recommended that Mayor John Hickenlooper consider a pilot needle-exchange program, DDSC Director Karla Maraccini said. The commission is looking at different programs to develop a model following Hickenlooper"s request for additional research. However, Denver District Attorney Mitch Morrissey has concerns that a local needle-exchange program would violate state law, according to Morrissey"s spokesperson Lynn Kimbrough. Eric Brown, a spokesperson for Hickenlooper, added, "Anything in contradiction to city or state law would have to be carefully considered." Proponents of needle-exchange programs say they prevent HIV and hepatitis C, but opponents say they condone injection drug use. Mark Thrun, director of HIV prevention for Denver Public Health, said, adding that needle-exchange programs prevent IDUs from "getting these chronic, potentially fatal diseases" and give public health workers "an opportunity to link them into treatment; and it lessens the economic burden on the already overburdened health care system." Thrun noted that several studies have found that needle-exchange programs do not encourage or prolong injection drug use and make IDUs more likely to seek treatment. In addition, a 2005 CDC study found that 86% of exchange programs make treatment referrals and that more than 80% offer counseling and testing for HIV/AIDS and hepatitis C.Nancy Steinfurth, executive director of the Hep C Connection, noted that an estimated 10% of HIV cases and 70% of hepatitis C cases are transmitted through needles (Auge, Denver Post, 5/15).
Medical Devices

Cimzia(R), The Only PEGylated Anti-TNF, Recommended For Approval In The EU For Rheumatoid Arthritis

UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Cimzia® (certolizumab pegol), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate. In these patients, Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX. The recommendation has been granted for Cimzia® to be administered as a subcutaneous injection using the pre-filled syringe. "The CHMP positive opinion is a significant milestone for UCB, but especially for people suffering from rheumatoid arthritis," said Roch Doliveux, Chief Executive Officer of UCB. "Cimzia® can provide an additional effective treatment option for patients with this debilitating condition, helping them to lead fuller lives." The European Commission usually delivers a European marketing authorisation subsequent to a positive CHMP opinion within three months. Following European marketing authorisation the first launches of Cimzia®, in the European Union, are anticipated before the end of 2009. The CHMP decision is supported by data from a comprehensive clinical development programme, involving more than 2 300 patients with RA and over 4 000 patient-years experience. In the pivotal clinical trials, reported serious adverse reactions, as with other anti-TNF"s, included infections (including tuberculosis) and malignancies (including lymphoma), and the most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data showed a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Cimzia® demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure. On 14 May, the U.S. Food and Drug Administration (FDA) approved Cimzia® for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Cimzia UCB


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