Mr. Dee, how about releasing some information on the BG trials! The lack of substantial information is causing the stock to drop. Thanks.
Here is an excellent sample of a recent press release:
RPI And Chiron Report First Human Results On New
Cancer Drug Designed to Cut Off Blood Supply to
Tumors
Two Phase I Angiozyme Human Clinical Trials Successfully Completed
Please read letter from CEO Ralph Christoffersen, Ph.D., which follows
BOULDER, Colo.--(BW HealthWire)--July 14, 1999-- Ribozyme Pharmaceuticals Inc. (RPI) (Nasdaq: RZYM - news) and
Chiron Corporation (Nasdaq: CHIR - news) today announced successful completion of Phase Ia and Ib human clinical trials of
the anti-angiogenesis cancer compound, ANGIOZYME(TM).
This ribozyme-based therapeutic has been moving rapidly through development since encouraging results in preclinical
toxicology and efficacy studies supported the initiation of clinical trials in healthy volunteers as well as cancer patients.
The Phase Ia trial demonstrated excellent tolerability of low single doses of ANGIOZYME(TM) administered either
intravenously or subcutaneously to healthy volunteers. The subsequent Phase Ib trial, performed with cancer patients, extended
to higher single doses of ANGIOZYME(TM) up to 300 mg/m2 to help define appropriate dosing for future Phase II and III
trials. Unlike many standard chemotherapies and other cancer drug regimens, no clinically significant drug-related side effects
were observed at any dose in the Phase Ia and Ib studies in normal volunteers or cancer patients.
In addition to studying tolerability, the Phase I trials were designed to compare the pharmacokinetics (PK) of
ANGIOZYME(TM) when administered either intravenously or by subcutaneous injection. PK data showed that
ANGIOZYME(TM) was detectable in patient serum up to 24 hours after subcutaneous injection, and at levels exceeding those
predicted to be necessary to achieve an anti-angiogenesis effect based on preclinical studies.
''These results further suggest ribozymes will be safe when given on therapeutic schedules,'' said Dr. Ernest Borden of the
Center for Cancer Drug Discovery and Development at The Cleveland Clinic Foundation. ''Because of its antitumor effects in
mouse models and targeted, selective mechanism of action, we look forward to initiation of more extended clinical trials in
cancer patients of this novel molecule.''
ANGIOZYME(TM) is the first chemically synthesized ribozyme to be studied in human clinical trials. This compound
specifically inhibits angiogenesis and resulting cancer tumor growth and metastases by inhibiting production of the Vascular
Endothelial Growth Factor receptor (VEGF-r), a key component that regulates the growth of new blood vessels that nourish
malignant tumors. By minimizing the new blood supply to tumors, ANGIOZYME(TM) was shown in preclinical studies to halt
tumor growth and prevent the growth and spread of metastases.
''We are very pleased with the results of our initial ANGIOZYME(TM) clinical trials,'' said Ralph Christoffersen, CEO and
President of RPI. ''We now know that single doses as high as 300 mg/m2 can be given intravenously or subcutaneously to
patients without any clinically significant side effects. If subsequent clinical studies confirm the results observed in preclinical
models, the persistence of ANGIOZYME(TM) seen in the blood after subcutaneous administration may ultimately permit home
treatment of cancer by self-administration, in a manner similar to current outpatient treatment of diabetes with insulin.''
''Chiron is pleased by the rapid progress in the ANGIOZYME(TM) clinical development program,'' said Bruce Scharschmidt,
MD, Vice President of Clinical Research and Development at Chiron. ''Tolerability -- both systemic and at the injection site --
has been excellent, and the blood levels of ANGIOZYME(TM) have exceeded the concentrations that have shown activity in a
variety of tumor models,'' he added.
The next round of clinical studies is slated to begin within six to nine months, and includes multiple dose schedules to study the
effects of chronic administration of ANGIOZYME(TM).
Ribozymes are the product of Nobel Prize winning science and are synthetically engineered to act as ''molecular scissors''
capable of cleaving target RNA in a highly specific manner.
RPI, located in Boulder, is the acknowledged leader in ribozyme therapeutic development. In addition to its Chiron
collaboration on ANGIOZYME(TM), it is partnered with Eli Lilly for development of HEPTAZYME(TM) for treatment of
Hepatitis C.
Chiron Corporation, with headquartered in Emeryville, Calif., is a leading biotechnology company that participates in three
global healthcare markets: biopharmaceuticals, vaccines and blood testing. The company is applying a broad and integrated
scientific approach to the development of innovative products for preventing and treating cancer, infectious diseases and
cardiovascular disease. This approach is supported by research strengths in recombinant proteins, genomics, small molecules,
gene therapy and vaccines.
This release may contain forward-looking statements that reflect management's current views of future events and operations.
The information is based on management's current expectations but actual results may differ materially due to various factors,
including those mentioned in this release, risks and uncertainties, including market conditions, competitive pricing, the successful
outcome of clinical trials, the timely receipt of regulatory approvals and those outlined in Chiron and RPI filings with the SEC.
Letter from the CEO
The attached press release has particular significance for RPI and
millions of cancer victims and their families. It is our belief that
ANGIOZYME(TM) and its ribozyme-based therapeutic approach hold
significant promise. The clinical explanations are outlined in the
press release and in other ANGIOZYME(TM) communications
materials...but...for the sake of clarity let me briefly summarize
what our scientists, researchers and medical staffs have accomplished
thus far.
The recent completion of the first set of ANGIOZYME(TM) human trials,
the first such tests for any ribozyme compound, indicates low toxicity
and high patient tolerability. What that means to a cancer victim is a
welcome alternative to toxic chemotherapies and other arduous cancer
treatments.
Now, we are a long way from actual patient use. But, the
information already confirmed by our valued development partner,
Chiron Pharmaceuticals, and independent researchers bodes well for the
future. Our Nobel prize-inspired work has shown that ANGIOZYME(TM) has
the ability to curtail tumor growth by turning off production of the
VEGF-receptor in blood vessel cells, thereby closing the door on tumor
growth and the spread of deadly cancers. As ribozyme technology is
somewhat eclectic, I wanted to make certain that you understood the
fundamental importance of today's announcement and other ribozyme work
now in progress here in Boulder. Lastly, I want to congratulate our
fine staff of biotech professionals for achieving this important
milestone.
Ralph E. Christoffersen, Ph.D.
CEO and President |
