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jackson...
thank you, i sensed a cleaning was a downdraft, but i like
to ask when i am guessing ( good guess or not). i took a position
based on the potential approval of paxene: baker norton pharmaceutical's version of bristol myers-squibbis paclitaxel. the trade name for the bm-s generic is taxol; ivax/baker norton has
presented a version under the name paxene. after a couple of days'
run-up, i passed on an 8 bagger ( i know, i know ) and opted to stick it out. god knows why...but i will say that your views on the drug
viability are not as sound as your knowledge of the company, and its trading. ( although i would hardly call your list of insider trading
"recent"; do you have an update? )
i agree there have been strides made, selling of assets, etc which seem to bode well: but what exactly is next? i have been trying to determine the current status of the fda application. on september 19
an advisory commitee recommended unanimously that this type of
treatment be approved as an alternative to the other version, based
on clinical trial evidence of its efficacy, safety, etc vs taxol.
there remains only the final step before production may be started.
that is, word on fda approval is either soon upon us, or not. it appears to the people at napro ( provider of the raw material as ivax's partner) that the failure to hear is more positive as time passes. in other words, why would the fda withhold for any length of time, an outright rejection. well, it remains to be seen. by the way,
paxene is also appropriate for treating breast cancer, and its cost is
far less prohibitive than taxol.
as to the financial reward...the whole reason on august 4, bm-s
applied to the fda for use of taxol in treating kaposi's sarcoma
stems from greed; THEY MAKE A BUNDLE ON TAXOL. the market is larger
than you realize, and i will post a link later to show you the numbers
involved.
anyway, should this happen, number 1 above, is not entirely an impossible scenario. number 2...is a good theory, however. and,
i have seen large block trading, buying that is, notwithsatnding
the selling, even on friday. i sense someone knows something...
randy
1
NLM CIT. ID: FDA/00912
TITLE: Paclitaxel in Advanced Refractory Kaposi's Sarcoma (AIDS-KS): A
Phase II Trial of Paclitaxel from Baker Norton Pharmaceuticals.
PROTOCOL ID NUMBERS:
FDA 273A
TRIAL CATAGORY:
AIDS-Related Malignancies
GENERAL DESCRIPTION: PURPOSE: To determine response rate, median time to tumor
progression, qualitative and quantitative toxicity and
reversibility of toxicity in patients with advanced refractory
AIDS-associated Kaposi's sarcoma (KS) administered a 3-hour
infusion of 100 mg/m2 of paclitaxel every 14 days. To evaluate
the clinical benefit of paclitaxel in this patient population by
evaluating self-reported responses to the Symptom Distress Scale
and by documenting and evaluating any changes in their
lymphedema, pain and disfiguring facial lesions. Methodology:
Patients are treated with paclitaxel 100mg/m2 intravenously every
2 weeks up to 10 courses. Patients who achieve a complete
response, receive 2 additional courses; those who achieve partial
response or stabilization, continue therapy until progression.
GENERAL DESCRIPTION:
METHODOLOGY: Patients are treated with paclitaxel 100mg/m2
intravenously every 2 weeks up to 10 courses. Patients who
achieve a complete response, receive 2 additional courses; those
who achieve partial response or stabilization, continue therapy
until progression.
PROTOCOL PHASE: Phase II
OPEN OR CLOSED INDICATOR: Open: Actively accruing patients (970714)
PROTOCOL DETAILS:
STUDY INTENT: Drug efficacy, Drug safety, Clinical Evaluation,
Adverse effects, Drug toxicity.
NUMBER OF PARTICIPATING AGENCIES: 1 unit.
DISEASE STUDIED: Kaposi's sarcoma.
OTHER PROTOCOL NUMBERS: IX-110-081. IND# 45,679
STUDY DESIGN: Multicenter; Open Label
PATIENT INCLUSION CRITERIA:
GENERAL INCLUSION CRITERIA: Patients must have: 1.
Microscopically confirmed diagnosis of KS associated with HIV for
which systematic therapy is medically indicated by the presence
of at least one of the following: A. >= 25 mucocutaneous (mouth
or skin) lesions. B. Symptomatic visceral involvement. C.
Symptomatic lymphedema (pain). 2. Minimum of 5 clearly measurably
cutaneous lesions by physical exam or measurable disease by
X-ray, CT or MRI. 3. Failed at least one systematic chemotherapy
regimen. [Refer to Laboratory values for additional
requirements.]
DISEASE STATUS: Patients must have the following conditions and
symptoms: 1. Microscopically confirmed diagnosis of KS associated
with HIV for which systematic therapy is medically indicated by
the presence of at least one of the following: A. >= 25
mucocutaneous (mouth or skin) lesions. B. Symptomatic visceral
involvement. C. Symptomatic lymphedema (pain). 2. Minimum of 5
clearly measurably cutaneous lesions by physical exam or
measurable disease by X-ray, CT or MRI.
HEMOGLOBIN: >= 6 g/dl. (Patients may be transfused)
GRANULOCYTES: >= 1000 cells/mm3.
PLATELET COUNT: >= 75000 platelets/mm3.
CD4 (T4 CELL) COUNT: Unspecified cells/mm3.
BILIRUBIN: <= 2.5 mg/dl.
SGOT(AST): <= 5 X ULN. (ULN = Upper Limit of Normal)
CREATININE: <= 1.5 X ULN.
KARNOFSKY: >= 60.
REPRODUCTIVE CRITERIA: Abstinence or effective method of birth
control / contraception including oral contraceptives during the
study. Not breast-feeding. Not pregnant.
PRIOR MEDICATION: Required: 1. At least one systemic chemotherapy
regimen that failed to maintain signficant benefit. NOTE:
Intralesional chemotherapy regimens are not considered as prior
chemotherapy. 2. At least 2 weeks since last dose of prior
systemic chemotherapy.
PATIENT AGE: 18 Years - 99 Years.
PAITENT GENDER:
MALE
FEMALE
PATIENT EXCLUSION CRITERIA:
GENERAL EXCLUSION CRITERIA: Patients with the following prior
conditions are excluded: 1. History of angina or myocardial
infarction within the past 6 months. 2. Second degree or third
degree atrioventricular block without a pacemaker. 3. Congestive
heart failure (poorly controlled). 4. History of prior malignancy
except: Completely excised in situ, carcinoma of the cervix or
nonmelanomatous skin cancer. Curatively treated other malignancy
with no evidence of disease for at least 5 years. [Refer to
Laboratory values for additional requirements.]
AGE: 01 Days - 17 Years.
REPRODUCTIVE CRITERIA: No abstinence or no agreement to use
effective method of birth control / contraception during the
study. Breast-feeding. Pregnant.
PRIOR MEDICATION: Excluded: Prior taxane therapy.
COMPLICATIONS: Patients with the following conditions and
symptoms are excluded: 1. Less than 2 weeks since major surgery.
2. Serious uncontrolled infection. NOTE: Must be ruled out by
thorough work up in patients with unexplained fevers, night
sweats, or involuntary weight loss of more than 10% normal
weight. 3. Leukopenia. 4. Thrombocytopenia.
SUBSTANCE IDENTIFICATION:
Drug 1 DRG-0190 Paclitaxel
OTHER TREATMENT INFORMATION:
DOSAGE SCHEDULE: Drug 1: 100 mg/m2 q 14 days
DELIVERY MODE: Drug 1: Intravenously, 100 mg/m2.
TREATMENT DURATION: Every 2 weeks up to 10 courses or if complete
response is achieved, patients are treated with 2 additional
courses. If a partial response or stabilization is achieved,
therapy may continue until progression.
END POINT: Response rate, time to tumor progression, and
toxicity.
SUPPORTING AGENCY:
Baker Norton Pharmaceuticals.
LATE REVISION DATE: 970714 |
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