The Burzynski Research Institute, Inc. (BRI) announced that it made three presentations of the results of phase II trials and mechanism of action data on it’s antineoplaston A10 and antineoplaston AS2-1 therapy (ANP). These findings were discussed at the 3rd Quadrennial Meeting of the World Federation of Neuro-Oncology in Yokohama, Japan.

In phase II studies, a total of eighty evaluable patients with advanced non-operable brainstem glioma (BSG) have been treated with ANP administered intravenously through an ambulatory infusion pump. Most of the patients (79%) were children, and 63% of all patients failed prior radiation therapy and/or chemotherapy. Due to low performance status, 52 patients were treated under Special Exception. The median duration of treatment was 5 ½ months. ANP was well-tolerated with easy manageable side effects of fatigue, skin rash and electrolyte abnormalities and no chronic toxicities. In the study group, 32% of patients have complete and partial responses, 43% have stable disease and 25% developed progression. Overall survival is 36% at 2 years and 25% at 5 years. These results compared favorably to radiation therapy and chemotherapy (Mandell, et al. 1999, 7% overall survival at 2 years and 0% at 5 years), but should be confirmed in phase III trials scheduled to begin in 2009.

The remarkable response of one of the patients who was treated on the study protocol was the subject of the second presentation. The patient is currently a 10 ½ year-old female who, as a six-week-old infant was diagnosed with BSG on August 12, 1998. The tumor was inoperable and the pediatric oncology service felt that chemotherapy as well as radiation therapy would not be an option. On October 14, 1998, she began intravenous infusions of ANP, which were discontinued on June 8, 2000. She achieved complete response in February 1999 and continues to be tumor free and lives a normal life since then.

The third presentation described new data on the molecular mechanism of action of ANP and concentrated on the most important findings from the study of the effect of active ingredients of ANP on the entire genome of malignant glioma (glioblastoma). Gene expression study and pathway analysis revealed the effect of ANP on 94 genes vital for the growth of malignant brain tumors. The study indicated that major metabolic pathways such as glycolysis were down-regulated. Many pro-apoptotic genes such as CASP3, CASP4, several TNFRs, TRF3 were up-regulated. The cell cycle was disrupted, and major checkpoint proteins were suppressed leading to apoptosis of glioblastoma cells. The Minichromosome Maintenance Complex (MCM) proteins are highly expressed in malignant cells and are promising targets for anticancer drugs. All six genes of the MCM were markedly suppressed by ANP. In conclusion, ANP inhibited MCM complex in malignant glioma, which may play an important role in control of tumor growth.

“These preclinical and clinical results are very encouraging, since they describe a positive ANP effect on one of the worst malignancies in the entire oncology field; they strongly support phase III trials scheduled to start later this year,” said Stanislaw R. Burzynski, M.D., Ph.D., Chairman and CEO of BRI.

Burzynski Research Institute, Inc. (BZYR) is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are focused on basic research and Phase III clinical trials.

Source
Burzynski Research Institute, Inc.

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) provided an update on the progress of two early clinical programs from its obesity R&D operations. Phase I clinical trial data on both PSN821 and PSN602 showed positive evidence of clinical activity, and both candidates are now progressing to the next stage of clinical development. PSN821 completed a single dose Phase I trial in healthy volunteers and diabetes patients, where evidence of glucose lowering was seen in response to a standard nutrient challenge. PSN602 completed a Phase I trial, where indications of activity in the form of significant reductions in food intake in standardized meal intake assessments were seen after 14 days of dosing in overweight/obese subjects. PSN821, an oral GPR119 agonist being developed for the treatment of type 2 diabetes and PSN602, an oral dual monoamine reuptake inhibitor and 5-HT1A agonist being developed for the treatment of obesity, were discovered by OSI’s diabetes and obesity R&D team and are wholly owned by OSI. Full data from the PSN602 Phase I trial will be presented at a scientific meeting in the second half of 2009.

“We are pleased with the progress we have made in the first-in-human studies of PSN821 and PSN602,” stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. “In keeping with our view that we should focus on establishing differentiation early in development programs, the follow-on studies for both PSN821 and PSN602 will include active comparator arms.”

PSN821 has progressed to a 14-day Phase I trial which may allow a preliminary assessment of impacts on gastric emptying and glucose data in addition to safety. Presuming continued success in this program, OSI will initiate a follow-on 28-day dosing Phase IIa study or a 3-month dosing Phase IIb study in 2010. The Phase II study will include sitagliptin as a comparator. PSN602 is now progressing with a 28-day dosing Phase IIa study, which includes sibutramine as a comparator.

PSN821-101: Phase I Data

In the double-blind, placebo-controlled, ascending single dose first-in-human study, PSN821 was generally well tolerated at doses up to 3000mg in healthy volunteers and 1000mg (the top dose tested) in patients with type 2 diabetes, with no clinically important adverse effects on laboratory tests, 12-lead ECGs or vital signs. Pharmacokinetics showed a profile consistent with once or twice daily dosing. In patients with type 2 diabetes, PSN821 showed substantial and statistically significant reductions in glucose responses to a standard nutrient challenge of approximately 30% at 250mg and 500mg. The data from this study was supportive of progression of PSN821 into a 14-day dosing ascending multiple dose study in healthy subjects and patients with type 2 diabetes and will be submitted for presentation at a scientific meeting together with the data from the multiple ascending dose study.

PSN602-101: Phase I Data

In the double-blind, placebo-controlled, ascending single and multiple dose first-in-human study, PSN602 was generally well tolerated at doses up to 20mg daily for 14 days. At 30mg daily for 14 days, the incidence of adverse events increased and one subject experienced syncope. There were no clinically important adverse effects on laboratory tests, 12-lead ECGs or vital signs apart from post-dose postural tachycardia. Pharmacokinetics showed a profile consistent with once daily dosing. In multiple dosing over 14 days in overweight/obese subjects, PSN602 showed substantial and statistically significant reductions from baseline in test meal intake of 36% and 25% at 20mg and 30mg respectively, comparing favourably with literature values for sibutramine of 15-25%. The data from this study is supportive of progression of PSN602 into a 28-day dosing clinical study, at a top dose of 20mg daily, with weight loss as the primary endpoint and sibutramine as a comparator, and will be presented at a scientific meeting.

About OSI Pharmaceuticals

OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality, novel and differentiated personalized medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity. For additional information about OSI, please visit http://www.osip.com.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, OSI’s and its collaborators’ abilities to effectively market and sell Tarceva and to expand the approved indications for Tarceva, OSI’s ability to protect its intellectual property rights, safety concerns regarding Tarceva, competition to Tarceva and OSI’s drug candidates from other biotechnology and pharmaceutical companies, the completion of clinical trials, the effects of FDA and other governmental regulation, including pricing controls, OSI’s ability to successfully develop and commercialize drug candidates, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.

Source
OSI Pharmaceuticals

View drug information on Tarceva.

WHEELING, W.Va., May 14 — Average drug costs rose sharply in 2008 despite increased use of generics, the prescription drug manager Medco reported in its annual database analysis.

“The unit cost increase of 4.4% observed in 2008 was substantially higher than the 0.4% increase seen in 2007,” according to the report. Medco attributed the spike to price inflation of branded drugs and increased prescriptions for specialty drugs — especially new, expensive brands introduced in 2007 and 2008.

Costs of branded pharmaceuticals jumped more than 8% in 2008, more than double the consumer price index inflation rate.

And the cost increases came even as generics increased their overall market share among Medco clients. Generics accounted for 64.1% of prescriptions filled in 2008, up from 59.7% the year before.

The increase in costs also came despite — or perhaps because of — a 1.1% drop in drug utilization, the first decline in 10 years, Medco said.

Utilization in this context is the number of days of therapy per plan member. Medco identified several causes for the drop:

• Conversion of cetirizine (Zyrtec) and the Miralax brand of polyethylene glycol from prescription to over-the-counter
• New safety concerns about blockbuster drugs for osteoporosis and anemia as well as hormone replacement therapies
• A dip in major drug launches, as many new drugs approved in 2008 were for uncommon conditions

The report noted that specialty pharmaceuticals — those not targeted to major chronic diseases such as hypercholesterolemia and diabetes — accounted for a growing share of drug spending.

Specialty products accounted for 12.8% of total pharmacy spending among Medco clients in 2008, up from 11.4% in 2007.

The rate of growth in specialty spending is increasing as well: 15.8% in 2008 versus 12.4% in 2007, each relative to the preceding year.

Overall, drug spending by Medco clients in 2008 rose 3.3%, the report said.

The company forecast accelerating growth in most components of drug spending over the next three years. The report writers expect utilization to resume its upward trend, with growth of 1% to 2% in 2011, as well as increases of up to 5% annually in price and drug mix.

Plan sponsors can expect overall drug spending to grow by 3% to 5% this year and 5% to 7% in 2011, Medco said.

“Over the next three years, more than 85% of drug trend [plan spending on pharmaceuticals] will be driven by drugs in six categories: cardiovascular, endocrine/diabetes, central nervous system, musculoskeletal/rheumatology, respiratory, and oncology,” according to the report.

The firm also estimated that 30% to 40% of late-stage investigational drugs are specialty pharmaceuticals, with nearly one-quarter of these for so-called orphan diseases.

Because orphan drugs are entitled to a period of market exclusivity, makers can charge very high prices for them.

Medco also identified some trends that could tame runaway drug spending.

Drugs that now account for a total of $34 billion in 2008 sales are scheduled to go off-patent and become eligible for generic production in the next three years.

The company also calculated that 16% of drug spending is for biologic drugs, which could also face competition for quasi-generic “biosimilar” drugs if Congress creates a pathway for such products with new legislation. Bills for that purpose were recently filed. (See Fight Looms Over Competing Biogeneric Bills)

Medco said biosimilar products could reach the market in a year or two after such legislation takes effect.

Also notable in the report was a pronounced age trend in 2008 plan spending patterns. Patients older than 65 showed a drop in spending of slightly more than 1% from 2007, which Medco attributed to strong use of generic statins.

On the other hand, spending for patients 19 and younger rose more than 4.5%. Increases of about 3.5% and 2.9% were seen among those 20 to 34 and 35 to 49, respectively.

But the opposite trend was seen for absolute plan spending, with the oldest patients accounting for the largest share. Mean spending per patient in the 65-plus range was about $1,700 in 2008, versus $200 for those 19 and younger.

The Medco database included 586 million prescriptions in 2008. The company serves health plans covering some 60 million people, including Medicare Part D participants.

Related source:

Medco’s 2009 Drug Trend Report

Related Article(s):

• Fight Looms Over Competing Biogeneric Bills