Here are some highlights from current pharma and clinical research news, views and data-
Gonorrhea Becoming Increasingly Resistant To Many Antibiotics.
"Gonorrhea may soon reach superbug status, thanks to growing antibiotic resistance," researchers in the UK say. "Choosing an effective antibiotic can be a challenge, because the organism that causes gonorrhea is very versatile and develops resistance to antibiotics very quickly," according to a presentation given at the Society for General Microbiology Spring Meeting this week. Prof. Catherine Ison, of the Health Protection Agency Centre for Infections, added, "The current drugs of choice, ceftriaxone and cefixime, are still very effective, but there are signs that resistance, particularly to cefixime, is emerging, and soon these drugs may not be a good choice."
Guidelines Call For Pediatric Drug Studies To Focus On Safety. Drug studies involving children must have a strong emphasis on safety, according to new guidelines issued by the American Academy of Pediatrics.The guidelines call for a "robust plan to monitor safety" and suggest "that a data- and safety-monitoring committee should be in place for all phase III trials, as well as for some phase I and II trials, especially if they involve blinding." In addition, the guideline authors maintain that "investigators should often defer pediatric studies until a drug is in the phase III stage in adults."
Glaxo To Offer Free Vaccines To Uninsured Americans.
GlaxoSmithKline PLC said Monday it is launching a program in the US to provide free vaccines to adults who don't have health insurance." The vaccines will include "shots for hepatitis A and B, tetanus, diphtheria and whooping cough," and its cervical cancer vaccine Cervarix "also will be included for women between the ages of 19 and 25." The GSK Vaccine Access program "is open to adults ages 19 and up whose income totals no more than $27,075 for a single person or $36,425 for a couple."
Pharmaceutical Company To Collaborate With NCI On Nanotechnology Research. Cranbury-based Cornerstone Pharmaceuticals said it has entered into an agreement with the National Cancer Institute to collaborate on research involving the company's proprietary nanotechnology." Notably, "as part of the collaboration, Cornerstone will apply its novel lipid oil nanoemulsion to a class of anti-cancer agents developed by the NCI's Center for Cancer Research Nanobiology Program."
Basal Insulin Requirements May Be Less On Day After Dialysis In Type 2 Diabetes Patients With ESRD. According to a study published March 9 in the journal Diabetes Care, "basal insulin requirements may be less on the day after maintenance hemodialysis in type 2 diabetic patients with end-stage renal disease (ESRD)." After studying 10 such type 2 diabetic patients in whom "intravenous insulin was adjusted every 30 minutes to achieve 5.5 ± 1.1-mmol/L glycemia during the 24-hour period preceding hemodialysis, during the hemodialysis session, and during the 24-hour period after hemodialysis," researchers found "a significant 25% reduction in basal insulin requirements the day after dialysis compared to the day before."
Carboplatin May Be Better-Tolerated Alternative For Treating Advanced Ovarian Cancer.
Intraperitoneal (IP) carboplatin might offer a better-tolerated alternative to intraperitoneal cisplatin for treatment of advanced ovarian cancer, results of a preliminary clinical study suggest." Administered "to an AUC of 6 over multiple cycles, IP carboplatin plus intravenous paclitaxel was well tolerated, and three-fourths of patients completed six cycles of therapy, researchers reported at the Society of Gynecologic Oncologists meeting." A second study "reported at the meeting demonstrated the feasibility of combining IP carboplatin with IV carboplatin and IP paclitaxel."
Vitamin B6 Appears To Play Role In Preventing Colon Cancer.
Vitamin B6 appears to play a beneficial role in preventing colon cancer," according to a paper in the Journal of American Medical Association. After reviewing data from 13 studies, researchers in Sweden "traced the beneficial effects to pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6." Although "taking vitamin B6 supplements did not appear to reduce the risk of colorectal cancer, increases in the level of PLP in the bloodstream were associated with an inversely lower risk of colorectal cancer."
Once-Daily Treatment Of Itraconazole May Help Treat Onychomycosis.
According to a poster presentation at the American Academy of Dermatology meeting, "once-daily treatment with a single 200-mg tablet of the oral antifungal itraconazole (Sporanox) demonstrated noninferiority to conventional treatment with two 100-mg tablets daily" in treating patients with onychomycosis, but "both active therapies resulted in significantly higher rates of complete cure and clinical improvement compared with placebo." Researchers reached this conclusion after randomizing "1,381 patients with culture-proven onychomycosis at a ratio of 3:3:1 to a single 200-mg tablet of itraconazole, two 100-mg tablets, or a single placebo tablet" for 12 weeks of daily treatment, followed by 40 weeks of additional follow-up.
Gonorrhea Becoming Increasingly Resistant To Many Antibiotics.
"Gonorrhea may soon reach superbug status, thanks to growing antibiotic resistance," researchers in the UK say. "Choosing an effective antibiotic can be a challenge, because the organism that causes gonorrhea is very versatile and develops resistance to antibiotics very quickly," according to a presentation given at the Society for General Microbiology Spring Meeting this week. Prof. Catherine Ison, of the Health Protection Agency Centre for Infections, added, "The current drugs of choice, ceftriaxone and cefixime, are still very effective, but there are signs that resistance, particularly to cefixime, is emerging, and soon these drugs may not be a good choice."
Guidelines Call For Pediatric Drug Studies To Focus On Safety. Drug studies involving children must have a strong emphasis on safety, according to new guidelines issued by the American Academy of Pediatrics.The guidelines call for a "robust plan to monitor safety" and suggest "that a data- and safety-monitoring committee should be in place for all phase III trials, as well as for some phase I and II trials, especially if they involve blinding." In addition, the guideline authors maintain that "investigators should often defer pediatric studies until a drug is in the phase III stage in adults."
Glaxo To Offer Free Vaccines To Uninsured Americans.
GlaxoSmithKline PLC said Monday it is launching a program in the US to provide free vaccines to adults who don't have health insurance." The vaccines will include "shots for hepatitis A and B, tetanus, diphtheria and whooping cough," and its cervical cancer vaccine Cervarix "also will be included for women between the ages of 19 and 25." The GSK Vaccine Access program "is open to adults ages 19 and up whose income totals no more than $27,075 for a single person or $36,425 for a couple."
Pharmaceutical Company To Collaborate With NCI On Nanotechnology Research. Cranbury-based Cornerstone Pharmaceuticals said it has entered into an agreement with the National Cancer Institute to collaborate on research involving the company's proprietary nanotechnology." Notably, "as part of the collaboration, Cornerstone will apply its novel lipid oil nanoemulsion to a class of anti-cancer agents developed by the NCI's Center for Cancer Research Nanobiology Program."
Basal Insulin Requirements May Be Less On Day After Dialysis In Type 2 Diabetes Patients With ESRD. According to a study published March 9 in the journal Diabetes Care, "basal insulin requirements may be less on the day after maintenance hemodialysis in type 2 diabetic patients with end-stage renal disease (ESRD)." After studying 10 such type 2 diabetic patients in whom "intravenous insulin was adjusted every 30 minutes to achieve 5.5 ± 1.1-mmol/L glycemia during the 24-hour period preceding hemodialysis, during the hemodialysis session, and during the 24-hour period after hemodialysis," researchers found "a significant 25% reduction in basal insulin requirements the day after dialysis compared to the day before."
Carboplatin May Be Better-Tolerated Alternative For Treating Advanced Ovarian Cancer.
Intraperitoneal (IP) carboplatin might offer a better-tolerated alternative to intraperitoneal cisplatin for treatment of advanced ovarian cancer, results of a preliminary clinical study suggest." Administered "to an AUC of 6 over multiple cycles, IP carboplatin plus intravenous paclitaxel was well tolerated, and three-fourths of patients completed six cycles of therapy, researchers reported at the Society of Gynecologic Oncologists meeting." A second study "reported at the meeting demonstrated the feasibility of combining IP carboplatin with IV carboplatin and IP paclitaxel."
Vitamin B6 Appears To Play Role In Preventing Colon Cancer.
Vitamin B6 appears to play a beneficial role in preventing colon cancer," according to a paper in the Journal of American Medical Association. After reviewing data from 13 studies, researchers in Sweden "traced the beneficial effects to pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6." Although "taking vitamin B6 supplements did not appear to reduce the risk of colorectal cancer, increases in the level of PLP in the bloodstream were associated with an inversely lower risk of colorectal cancer."
Once-Daily Treatment Of Itraconazole May Help Treat Onychomycosis.
According to a poster presentation at the American Academy of Dermatology meeting, "once-daily treatment with a single 200-mg tablet of the oral antifungal itraconazole (Sporanox) demonstrated noninferiority to conventional treatment with two 100-mg tablets daily" in treating patients with onychomycosis, but "both active therapies resulted in significantly higher rates of complete cure and clinical improvement compared with placebo." Researchers reached this conclusion after randomizing "1,381 patients with culture-proven onychomycosis at a ratio of 3:3:1 to a single 200-mg tablet of itraconazole, two 100-mg tablets, or a single placebo tablet" for 12 weeks of daily treatment, followed by 40 weeks of additional follow-up.
