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New Update
From the Investors village board:
Real Insider Buying:
Insider Buying is what actually took place by the actions of ACEL's CEO ... when she converted 122,000 of her options into ACEL stock for an average conversion price of .79 on 2-1-08 ... which cost her approximately $100,000 cash out of pocket. This is the definition of "Insider Buying".
After much research and DD on this issue ... I stand grossly corrected and I apologize ... for my completely erroneous and wrong initial opinion of the CEO's actions during the week ending 2-1-08. In my initial surprise and anger to see " an intent to sell shares/ rule 144 filing " by the CEO on 2-1-08 ... I wrongly leaped to the erroneous conclusion ... that she had in fact sold shares. In my haste ... lack of DD and anger ... my initial post on the matter was factually wrong in opining that the CEO had engaged in harmful "Insider Selling". In fact ... she clearly engaged in real " Insider Buying " by investing over $100,000 to convert options into 122,000 shares of ACEL.
This real " Insider Buying " should actually have been seen and perceived by investors such as myself as the positive news ... that " Insider Buying " is always percived as in the marketplace. My hasteful and erroneous post helped to prevent this positive development being accurately seen as the positve reality that it actually is. For my haste and anger and cluelessness in posting completely erroneous opinions and conclusions here in my initial post on the matter ... I apologize to the CEO and all good readers of this board. My cluelessness angrily described a positive development as a negative concern ... and helped to wrongfully cause much confusion and anxiety among good investors and readers here.
At this point in time ... all that I can do ... is to admit my gross mistake and apologize for my previous hasteful, angry and clueless post on the matter.
In spite of my initial, clueless post on the issue ... the fact of the matter was and still remains ... that the CEO engaged in over $100,000 of " Insider Buying " on 2-1-08.
That was and is a positive reality that my hasteful cluelessness helped to obscure. I am sorry.
Update ACEL
The candles would have us believe a bottom is being put in.
MFI and Momentum indicators haven't seen it yet, and as a result it's still on watch as opposed to jump in and start rowing.
Last week's CEO Form144 sent it reeling.
Please link back one post for the chart.
fringe
fringe ... what is your current TA showing on ACEL here?
Phase III clinical trials latest recording
recording dated 2-6-2008
Estimated Completion Date: February 2008
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
This study is ongoing, but not recruiting participants.
Sponsored by: Alfacell
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003034
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
Condition Intervention Phase
Malignant Mesothelioma
Drug: doxorubicin hydrochloride
Drug: ranpirnase
Procedure: chemotherapy
Phase III
Genetics Home Reference related topics: Cancer
MedlinePlus related topics: Cancer Mesothelioma
ChemIDplus related topics: Doxorubicin Doxorubicin hydrochloride Ranpirnase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
Survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
Objective response [ Designated as safety issue: No ]
Time to best response [ Designated as safety issue: No ]
Response duration [ Designated as safety issue: No ]
Estimated Enrollment: 300
Study Start Date: May 1997
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:
Compare the efficacy of doxorubicin with or without Onconase in patients with malignant pleural or peritoneal mesothelioma.
Compare the safety profile of these regimens in these patients.
Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive Onconase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with Onconase as a single agent until disease progression.
Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 21 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma
Measurable or evaluable disease
CALGB groups 1-4
No CNS metastases
PATIENT CHARACTERISTICS:
Age:
21 and over
Performance status:
ECOG 0-1
Life expectancy:
Not specified
Hematopoietic:
WBC greater than 3,500/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
SGOT no greater than 2 times upper limit of normal
Bilirubin no greater than 2 mg/dL
PT and PTT normal
Renal:
Creatinine normal
Cardiovascular:
No symptomatic New York Heart Association class II-IV cardiovascular disease
No congestive heart failure
No angina pectoris
No cardiac arrhythmias
No uncontrolled hypertension
No cerebrovascular disease
Metabolic:
No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No serious infection
No uncontrolled psychosis or neurologic disease (e.g., seizure disorders)
No uncontrolled diabetes mellitus
No other primary malignancy within the past 5 years except nonmelanoma skin cancer
No senility or emotional instability
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
No more than one prior systemic chemotherapy regimen
No prior doxorubicin
At least 6 weeks since prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy
Surgery:
Prior surgical resection allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003034
Locations
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Michigan
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805-1983
United States, Missouri
Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
St. Charles, Missouri, United States, 63301
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114-4199
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany, D-82131
Asklepios Klinik Harburg
Hamburg, Germany, D-21075
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Hospital Grosshansdorf
Grosshansdorf, Germany, D-22927
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Ospedale San Martino
Genoa, Italy, 16132
Poland
Klinika Chrorob Pluc I Gruzlicy
Zabrze, Poland, 41-803
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
Medical University of Gdansk
Gdansk, Poland, 80-211
University School of Medical Sciences
Poznan, Poland, PL-60 569
Sponsors and Collaborators
Alfacell
Investigators
Study Chair: Diane Scudiery Alfacell
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000065639, ALFACELL-P30-302, NCI-V97-1273
First Received: November 1, 1999
Last Updated: December 25, 2007
ClinicalTrials.gov Identifier: NCT00003034
Health Authority: United States: Federal Government
Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Study placed in the following topic categories:
Ranpirnase
Mesothelioma
Adenoma
Doxorubicin
Recurrence
Neoplasms, Glandular and Epithelial
Additional relevant MeSH terms:
Doxorubicin
Protein Synthesis Inhibitors
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Mesothelial
Therapeutic Uses
Enzyme Inhibitors
Antibiotics, Antineoplastic
Molecular Mechanisms of Action
Pharmacologic Actions
ClinicalTrials.gov processed this record on February 06, 2008
U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act
Here is a direct link to the FDA's latest PIII Clinical Trials:
http://clinicaltrials.gov/ct2/show/NCT00...
ACEL Putting In a Nice Show Today
The turn is in.
Please link back for the chart.
Have a good weekend all.
fringe
fringe ... current upward channel is holding up real nice.
It looks like the bottom of this up/channel since the move/up from $1.45 four weeks ago is around $2.40 right now. The top of the current channel seems to be around $3.10 right now. Looks like about a 70 degree upward -sloping channel we are in now. One week from today ... bottom of channel will be around $2.80 ...and top of this channel will be around $3.50
If we just keep bouncing along the bottom of the current channel ... ACEL should be around $2.80 a week from now. If we spike up ... we can be around $3.50 by next Friday ... and still be in this channel. We have nice growing volume too. Looks like more players are becoming aware of the potential here ... day by day.
What is your TA showing here now?
It's Holding Support
... and the Bollinger configuration remains very bullish.
Looks to me like it's being managed, given the volume and lack of PPS movement in either direction.
fringe
Bankthis------thank you. sure Investvillage has more ,but i'm on ihub. Chart is healthy ,fringe knows all about that.
fringe ... what is your current technical update on ACEL?
Volume has been picking up since positive annual shareholders meeting yesterday.
ACEL CURRENT REPORT - FORM 8-K
Sorry for the link, file too large to paste.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5416063
NOTES FROM TODAY'S ACEL ANNUAL STOCKHOLDERS MEETING
Copied and edited from another post:
The official part of the meeting began at 1:05 pm, with Sidransky serving as meeting chair, Kenyon as secretary. Shogen was, of course, also present, but a non-participant. 4 of the remaining 5 board members were there (Carter was not), as was a representative from PAR pharmaceutical, the company with which ACEL recently completed the US partnership deal. Anyway, by the time all directors were (re)elected and JH Cohn (re)appointed as auditor, it was all of 1:12 pm, and the official part of the meeting ended. (By the way: like last year, no vote totals for directors were announced; these will allegedly be included in the official minutes of the meeting at some later date.)
Sidransky then began a brief informal presentation. He said he views the company today as "fundamentally different" from last year, mainly due to the deal with PAR that gives ACEL a "strategic partner" to fully develop the value of Onconase. He said the recent move to split the jobs of Board Chair and CEO was good for 2 reasons: it is consistent with sound corporate governance principles; and it will allow Shogen to focus on what she does best, which is concluding the clinical trial, submitting the NDA, and getting it approved. [I have my own theories about why the change was made, and made now, but they are not material to this report.]
Finally, Sidransky said that the whole company now is "invigorated" and "focused like a laser" on the success of the P3b and NDA processes. He said that he understands as Board chair that his top priority is fulfilling his fiduciary duty to shareholders by maximizing the value of their investment.
That presentation lasted 3 minutes, and Sidransky looked perfectly at ease, sounded confident, and did not appear to be reading from a script. At 1:16 pm, Larry Kenyon took over to conclude the presentation and handle Q&A. He said that at last year's meeting, the big questions were (1) will additional capital be needed; (2) will we ever have a US partner; (3) when will the P3b trial end; and (4) when will the NDA be submitted? Today, he said, the company's financial position is "adequate," mainly due to the $6.9M cash received in the first half of (fiscal) '08: $5M from PAR, 0.1M from the BL&H (Asia) deal; and $1.8M in sales of NJ tax losses. The company has approx. $10M cash on hand, and top priority for spending is on the NDA. Other spending (i.e., on other clinical trials, etc.) will be contingent on maintaining a sufficient reserve to fund the NDA, and later on receipt of milestone payments from PAR and others (after FDA approval). In general, he seemed pretty comfortable that current $$ are enough to carry out the plan. Now we do have a US partner, and Kenyon stated that the partnership with PAR will enhance development and commercialization. As for the P3b trial, he reiterated the news about 311 evaluable events, and said "all non-clinical material" needed for the NDA has "already been submitted" under the rolling NDA procedure at the FDA. The clear implication is that everything left on the NDA has to await the conclusion of the trial. The company is also now "planning" (but apparently not yet executing on) the follow-on submissions needed for drug approvals in Europe (all of which will be largely based on the FDA submission in any case).
Kenyon also said that, under the PAR relationship, any other Phase 2 Onc trials will be "subject to discussion" with PAR; and any other Phase 3 trials will depend on the milestone payments from PAR for funding. At some point, he indicated that ACEL has final say on "development" of Onc, but PAR now has final say on "commercialization" matters.
Kenyon reafirmed the plan to announce event #316 within 72 hours of occurrence -- said this will trigger the "locking of the database," statistical analysis, and a pre-NDA meeting with FDA staff, under usual FDA procedures.
Kenyon ended his presentation by listing ACEL's 2008 objectives: submit the NDA, begin work on European approval filings for Onc, do a licensing deal for Western Europe (which may not occur this year, he said), begin Phase 2 trials of Onc vs. other cancers (in consultation with PAR), and begin identifying possible new drug applications for Amphinase. Kenyon's presentation eded at 1:30, followed by Q&A, the significant portions of which are as follows.
Ray Meyers of EGE asked how long it would take to file the NDA after event #316, and when/whether a "top line summary" of trial data would be released beforehand. Kenyon said the goal is still to submit the NDA within 4 months after #316, but this will depend on the data and on the pre-filing meetings with the FDA. Meyers also asked whether the "delay" in reaching 316 is good news because it means people are living longer on Onc. Sidransky said that he is an optimist, and that would be the optimist's view (he called it "seeing a durability of patient response") -- but that until all the data were in and studied, no conclusions could be drawn.
A question was asked about the milestone payments under the PAR deal. Kenyon clarified that $30M will be due upon NDA APPROVAL. The other $190M in potential milestone payments turn on subsequent sales of Onc and subsequent use of Onc vs. other indications.
There was a fair amount of Q&A over "evaluable events" and when #316 will occur. The gist of the answers: the "unevaluable events" are comprised of patients who turned out not to meet the initial trial criteria and/or who did not end up receiving the appropriate amount of the drug being tested. As of September, there were 290 "evaluable" events out of 316 total events (i.e., 26 nonevaluables); the proportion hasn't changed dramatically and is not unusual in this kind of trial. There are still enough people in the trial to make 316 evaluable events inevitable -- but no one would hazard a specific guess as to when. Kenyon said the company is "completely satisfied" with the interim data, but still need to await 316 for statistical reasons. Finally, Kenyon said that although he always "waffles" on this and leaves options open, he doesn't seem to foresee the need for any major dilutive new financings to get the NDA done, even though the bulk of NDA expense is still to come (Kenyon estimated this as a "couple of million").
One last thing: several shareholders asked questions indicating great disappointment and frustration about the quality of ACEL investor relations/shareholder communications, etc. Kenyon handled these with grace and promised that these areas are being addressed.
The Q&A session (and the meeting) ended at 2:02 pm. Less than an hour stem to stern. FWIW, Shogen, Sidransky and Kenyon all seemed way more relaxed and genuinely accessible and warm than at past meetings. I do not recall Shogen saying a single word from the dais, nor were there the usual torrents of slides devoted to financial results, other real or imagined future clinical programs, etc. In short, a decidedly different and positive change from prior meetings. The refreshments, however, are still not worth the trip (insipidly-sweet cookies).
Update ACEL
Notwithstanding that the immediate Chart trend continues to weaken, I like the overall picture very much, especially from a Bollinger viewpoint. As manysevens said to me the other day, "the PPS just got out ahead of itself a little bit."
Watch Fast Aroon on the Daily Chart, PPS is sitting right on pSAR support.
ACEL Updates Phase IIIb trials...
http://biz.yahoo.com/prnews/080130/nyw032.html?.v=101
Interesting message from the iv board: hope you like it.
Anyone out there who is not delusional and is interested in an apples-to-apples comparison of Alimta and Onconase, look at the report of Alimta as a single agent for treatment of mesothelioma in the Expanded Access Program that made Alimta available to meso patients even before it was approved for marketing: ASCO 2007 abstract #7709: Median Survival Time 14.1 months. Then have a look at ASCO 2000 abstract #2274 for the info on Onconase as a single agent from the first meso trial that FAILED: MST for the Intent To Treat group of patients was a pathetic 7.7 months. That Treatment Target Group hocus-pocus was the result of retrospective data-mining, and was not part of the trial's protocol. But it is central to the so-called IIIb. What it amounts to is cherry-picking of patients who are good candidates for extended survival going into the trial. It is an admission that Onconase does not work for a large segment of the general patient population. The Alimta trials did not employ that kind of hocus-pocus. See July 2003 editorial in the Journal of Clinical for their description of LLY's Alimta trial as a model for phase III trials. Then look for a similar editorial on any of of ACEL's three FAILED phase III trials, or on the current sloppy phase IIIb that has been going on, and on, and on, since the turn-of-the-century.
fringe ...
What's your take on ACEL here now.
Stock is moving up on growing volume.
How do the technicals look now?
Intraday SnapShot
Daily pennant forming
Here is a brand new article on ACEL ... with strong BUY recommendation:
http://seekingalpha.com/article/62032-alfacell-gets-my-vote-of-confidence
Alfacell (ACEL) and Dendreon (DNDN) were identified by participants in a survey that I conducted earlier in the year which asked for readers’ top emerging healthcare stock pick for 2008 with market caps below $500 million and share prices greater than 50 cents. As a follow-up to one of my first Seeking Alpha articles last June on the Company, I believe that Alfacell will be the top performing stock of those mentioned in my investor survey. In just the last few weeks, the Company has received additional votes of confidence in the form of upfront cash from multiple licensing partners for its experimental cancer drug Onconase.
In mid-January, a Par Pharma (PRX) subsidiary, Strativa Pharma, announced an exclusive licensing deal for exclusive marketing, sales, and distribution rights to Onconase for the treatment of cancer in the domestic market. Alfacell retains all rights and obligations for product manufacturing, clinical development, and obtaining regulatory approvals, as well as all rights for non-US markets. Alfacell received $5 million in upfront cash with another $30 million due at FDA approval and provides the Company with up to $225 million in non-dilutive funds in the form of future development milestone payments, royalties on sales, and an option for a co-promotion effort in the future. As a follow-up deal one week later, Alfacell announced a distribution agreement with BL&H Co. Ltd. for the commercialization of Onconase in South Korea, Taiwan, and Hong Kong. Alfacell received an up-front fee of $100,000 and is eligible for milestone payments based on the regulatory and net sales milestones with a generous 50% royalty payable to the Company. Alfacell will manufacture and supply the product to BL&H, but unlike the earlier agreement BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.
Alfacell investors are eagerly awaiting the pivotal Phase 3b results for Onconase to support the FDA filing and approval process for an Orphan Drug indication in the treatment of inoperable, malignant mesothelioma – a $300 million global market opportunity versus a current market cap just over $100 million. The drug is also being evaluated in earlier stage studies for non-small cell lung cancer and other solid tumors, which represent even larger market opportunities. Previously announced interim results based on one-third of the required events (deaths) of the study — which evaluates the efficacy, safety and tolerability of the combination of Onconase plus doxorubicin as compared to doxorubicin alone — have been reported and were sufficient to continue the trial as planned. The overall median survival time demonstrated a trend favoring the Onconase plus doxorubicin treatment group (12 months) over the doxorubicin group (10 months).
Alfacell has guided for the following timeline to complete its rolling NDA submission: (1) report occurrence of 316 events (deaths) via press release within 72 hours of confirmation and (2) if data are positive, submit the final clinical section of the Company’s rolling New Drug Application within four months of reporting the 316 events. The timeline for reaching 316 deaths in the Phase 3b trial has been delayed several times already, which may be a good sign for investors if Onconase is responsible for prolonging the patients’ lives in the study and thereby delaying the occurrence of 316 deaths in the trial. I believe the survival benefit trends observed in the interim analyses for Onconase plus doxorubicin will lead to a statistically significant survival benefit for the drug, and the recently announced licensing deals including over $5 million in upfront cash provide me with additional confidence on the pending results and the near-term explosive upside potential for the stock.
ACEL must be a winner!...Fringe, I know you pick the good ones; ACEL has got my attention!
Company Release - 01/22/2008 08:30
Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement With BL&H for South Korea, Taiwan and Hong Kong
SOMERSET, N.J., Jan. 22 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that it has entered into a distribution agreement with BL&H Co. Ltd., a leading pharmaceutical company in Southeast Asia, for the commercialization of ONCONASE(R) (ranpirnase) in South Korea, Taiwan and Hong Kong. ONCONASE, the company's lead drug candidate, is currently being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a confirmatory Phase IIIb clinical trial.
Under the agreement, Alfacell has granted BL&H exclusive rights in the defined territory for the marketing, sales and distribution of ONCONASE. Alfacell has received an up-front fee of $100,000 and is eligible for milestone payments based on the achievement of certain regulatory approvals and net sales levels. Alfacell will also receive 50% of all net sales in the territory. In addition, Alfacell will manufacture and supply the product to BL&H, while BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.
"This partnership represents another important step forward in the execution of our global commercialization strategy for ONCONASE," said Kuslima Shogen, chief executive officer of Alfacell. "BL&H's extensive market knowledge, commercial capabilities, established oncology franchise and successful track record in the marketing and sales of several leading cancer therapeutics provide Alfacell with an ideal partner to maximize the potential of ONCONASE in this region. We look forward to a successful collaboration with BL&H."
D.C. Roh, president of BL&H, said, "We are pleased to enter into this agreement with Alfacell. We believe that ONCONASE will prove to be a promising new treatment option for patients suffering from mesothelioma. We look forward to working with Alfacell on a successful product launch."
About ONCONASE(R)
ONCONASE is a first-in-class product candidate from Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis (natural death of cells) via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
About BL&H
BL&H is a privately owned pharmaceutical company based in South Korea. BL&H was established in 1999 with the aim of becoming a leader in the delivery of pharmaceuticals and services that fulfill unmet medical needs in the Korean market. BL&H specializes in hospital-based products in hematology, oncology, rheumatology and respiratory medicines. The BL&H management team has extensive experience in the pharmaceutical and healthcare sectors and in bringing specialty products to market.
Safe Harbor
This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in the outcome of clinical trials for ONCONASE, the company's ability to secure necessary marketing approvals of ONCONASE from regulatory agencies, transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Media and Investor Contact:
David Schull or Wendy LauRusso Partners
212-845-4271
david.schull@russopartnersllc.comwendy.lau@russopartnersllc.com
SOURCE Alfacell Corporation
FRINGE - CAN YOU PUT THIS IN THE IBOX?
Company Release - 01/18/2008 08:30
Alfacell Announces ONCONASE(R) Purchase and Supply Agreement with Scientific Protein Laboratories
SOMERSET, N.J., Jan. 18 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that it has entered into a purchase and supply agreement with Scientific Protein Laboratories LLC (SPL) for the commercial production of ONCONASE(R) (ranpirnase). ONCONASE, the company's lead drug candidate, is currently being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a confirmatory Phase IIIb clinical trial.
"SPL has been involved in the production of ONCONASE from the very first batches," said Kuslima Shogen, chief executive officer of Alfacell. "We have been pleased with the superb performance of the extremely well qualified team at SPL for many years and are confident that the commercial production of ONCONASE is in the right hands. This agreement is another step forward for Alfacell as we plan for the commercialization of ONCONASE."
"We have been very enthusiastic about the Alfacell project from the very beginning," said David Strunce, president and chief executive officer of SPL. "We are impressed by the way that Alfacell has successfully guided their novel product through the development phases, and we are pleased to have the opportunity to continue the collaboration with the Alfacell team into the commercial stage."
About Scientific Protein Labs LLC
For over three decades, Scientific Protein Laboratories (SPL) has been a leading global supplier of high quality active pharmaceutical ingredients (APIs) from natural sources. The company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP and Pancrelipase USP in serving the pharmaceutical, veterinary and food industries globally. Beyond supplying high quality proprietary APIs, SPL provides contract process development and cGMP manufacturing services, including heparin derivatives, natural products extraction, fermentation and purification. SPL is among a small number of companies that have successful track records in efficient process development, analytical testing, quality assurance and regulatory support required to provide customers with cGMP compliant APIs at all phases of clinical development and straight through to commercial launch.
About ONCONASE(R)
ONCONASE is a first-in-class product candidate from Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis (natural death of cells) via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
Safe Harbor
This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in the outcome of clinical trials for ONCONASE, the company's ability to secure necessary marketing approvals of ONCONASE from regulatory agencies, transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Media and Investor Contact:
David Schull or Wendy LauRusso Partners
212-845-4271
david.schull@russopartnersllc.comwendy.lau@russopartnersllc.com
SOURCE Alfacell Corporation
FRINGE – CAN YOU PUT THIS IN THE IBOX?
Company Release - 01/17/2008 08:30
Alfacell Appoints David Sidransky Chairman of the Board of Directors
SOMERSET, N.J., Jan. 17 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that its board of directors has appointed David Sidransky, M.D., chairman. Dr. Sidransky, 47, has served as Alfacell's vice chairman since January 2007 and as a director since May 2004. He succeeds Kuslima Shogen, Alfacell's chairman since 1996. Ms. Shogen continues to serve as Alfacell's chief executive officer and a director.
Separating the roles of chairman and chief executive officer is considered a best practice of corporate governance and will allow the company to focus on the completion of its rolling new drug application for ONCONASE(R) and pursue new business relationships and opportunities. The change in responsibilities is consistent with the recent and ongoing efforts of the board of directors to develop a succession plan that allows for a smooth leadership transition upon the potential marketing approval of ONCONASE.
"Dr. Sidransky is an asset to our company and our board," said Ms. Shogen. "David and I have worked closely together over the past four years, and his appointment to the chairman's post is a positive step forward as we progress toward our goal of completing Alfacell's transformation into a successful commercial-stage biotechnology company."
About David Sidransky, M.D.
Dr. Sidransky joined the Alfacell board of directors in May 2004 and serves as Chairman of Alfacell's scientific advisory board. The founder of several private biotechnology companies, he has served as a scientific advisory board member for many private and public biotechnology companies, including MedImmune, Telik, Roche and Amgen. In addition, he is a director of ImClone Systems, Champions Biotechnology Inc. and Xenomics Inc. Previously, he was a member of the board of scientific counselors at the NIDCR and a member of the Recombinant DNA advisory committee at the National Institute of Health NIH (RAC).
Currently, Dr. Sidransky is the director of the Head and Neck Cancer Research Division at Johns Hopkins University School of Medicine. In addition, he is a professor of Oncology, Otolaryngology-Head and Neck Surgery, Cellular & Molecular Medicine, Urology, Genetics and Pathology at John Hopkins University and Hospital. Dr. Sidransky is certified in Internal Medicine and Medical Oncology by the American Board of Medicine.
More than 350 articles written by Dr. Sidransky have been published in peer-reviewed journals. Furthermore, he has contributed more than 60 cancer reviews and chapters to industry publications and has secured numerous biotechnology patents. He has been the recipient of many awards and honors, including the 1997 Sarstedt International prize from the German Society of Clinical Chemistry, 1998 Alton Ochsner Award Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda Rosenthal Award presented by the American Association of Cancer Research. Dr. Sidransky received his bachelor's degree from Brandeis University and his medical degree from the Baylor College of Medicine.
About ONCONASE(R)
ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
Safe Harbor
This press release includes statements that may constitute "forward- looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in the outcome of the company's ongoing Phase IIIb clinical trial for its lead product, the company's ability to secure necessary approvals from regulatory agencies, uncertainties involving the ability of the company to finance research and development activities and its ongoing operations, potential challenges to or violations of patents, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Media and Investor Contact:
David Schull or Wendy LauRusso Partners
212-845-4271
David.Schull@russopartnersllc.comWendy.Lau@russopartnersllc.com
SOURCE Alfacell Corporation
FRINGE – CAN YOU PUT THIS IN THE IBOX?
Company Release - 01/15/2008 08:30
Alfacell Corporation Licenses ONCONASE(R) U.S. Commercial Rights to Strativa Pharmaceuticals
SOMERSET, N.J., Jan. 15 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that it has entered into a license agreement with Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), for the commercialization of ONCONASE (ranpirnase) in the United States. ONCONASE is currently being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a confirmatory Phase IIIb clinical trial.
Under the terms of the agreement, Strativa will have exclusive marketing, sales and distribution rights to ONCONASE for the treatment of cancer in the U.S. and its territories. Alfacell will retain all rights and obligations for product manufacturing, clinical development and obtaining regulatory approvals, as well as all rights for non-U.S. jurisdictions where Alfacell does not currently have ONCONASE partnerships. Joint oversight committees with members from Alfacell and Strativa will manage the alliance.
This agreement could provide Alfacell with up to $225 million in cash milestones plus additional non-dilutive funding, including:
-- An initial payment upon signing of $5 million in cash and up to $30
million in cash upon FDA approval of ONCONASE for UMM.
-- Additional milestone payments pursuant to the achievement of
development and regulatory milestones for new ONCONASE cancer
indications as well as net sales milestones.
-- An option, at Alfacell's discretion, to co-promote ONCONASE in the
future, with support from Strativa. Strativa will provide technical
expertise for a future Alfacell oncology sales force, as well as
funding for certain associated costs.
In addition, Alfacell will receive double-digit royalties on net sales of ONCONASE.
"From the beginning of our discussions, we were impressed with the capabilities, resources and commitment to success at Strativa," said Kuslima Shogen, Chairman and CEO at Alfacell. "These factors were critical for us in choosing the right partner for ONCONASE in the United States. We look forward to collaborating with Strativa as we develop ONCONASE in additional oncology indications, and are confident that this partnership will pave the way for future success for both companies."
John A. MacPhee, president of Strativa, said, "We are very excited to be partnering with Alfacell, an innovative biopharmaceutical company, to meet the treatment needs of mesothelioma patients. Adding ONCONASE to Strativa's product portfolio as our first oncology therapeutic advances our goal of becoming a leading specialty pharmaceutical company. We look forward to collaborating on future projects with Alfacell."
About ONCONASE(R)
ONCONASE is a first-in-class product candidate from Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis (natural death of cells) via multiple molecular mechanisms of action.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in non-small cell lung cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
About Strativa
Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Supported by Par's financial and organizational capabilities including substantial cash resources, Strativa Pharmaceuticals is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for introduction and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
Safe Harbor
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainties involved in the outcome of clinical trials for ONCONASE, the company's ability to secure necessary marketing approvals of ONCONASE from regulatory agencies, transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, dependence upon third-party vendors, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
Media Contact: Investor Contact:
David Schull or Wendy Lau Andreas Marathovouniotis
Russo PartnersRusso Partners
212-845-4271 212-845-4253
david.schull@russopartnersllc.comandreas.marathis@russopartnersllc.comwendy.lau@russopartnersllc.com
SOURCE Alfacell Corporation
FRINGE – CAN YOU PUT THIS IN THE IBOX?
fringe ...
Thanks for your assessment.
This Wednesday is ACEL's annual shareholder meeting. Should be lot's of action there. They have a history of releasing PR's the morning of their annual meeting. Could be a lot of info coming out of that meeting.
Anyone here attending ... please report back here.
Technical Assessment
It appears as if the stock wants to revisit recently crossed MA's hovering below before it moves off, allowing the Bollingers to close up again. I think that the Weekly Chart gives excellent guidance as regards the potential for movement out of the descending triangle pattern, a longer, more rational view perhaps.
I think we find out tomorrow what the stock will do near term.
The stock is also being manipulated with many hundred share trades, so calling TA will be difficult. The MM can turn this around any time, walking it up and down at will.
fringe
yup should get real interesting very soon
Onconase PIII Details link:
http://www1.investorvillage.com/smbd.asp?mb=470&mn=9167&pt=msg&mid=3970888
Fringe...It's great having you running ACEL's board...Wow!!
Here is a direct link to the FDA's latest PIII Clinical Trials:
http://clinicaltrials.gov/ct2/show/NCT00003034?term=doxil&rank=30
fringe_remnant ... It is great to have you serving as The Moderator of ACEL's message board at ihub! Your track record of success ... speaks for itself. Your record of picking winners at ihub brings real excitement to this board. Your confidence in ACEL's enormous potential speaks volumes. Congratulations and best wishes on your new endeavor here.
With apologies to " Casablanca " ... Welcome to the fight. Now I know that our side will win!
Spread the word ... " fringe_remnant is moderating the ACEL ihub board!!!!!
Let us know how we can be of assistance to you and this board.
Spread the word ... ACEL's message board at ihub is alive and thriving! This will become ... ACEL's premier and most-active stock message board. ACEL is now on the radar screen ... ready for take-off!
The time to start posting questions ... DD ... TA
and research begins now. Start your engines!
BTW fringe ... what is your current TA on ACEL showing now?
nice posts /info
fda should approve later in the year ,i will guesstimate aug-sept area... hard to say but for sure this year.
Thanks for the good DD.
Please keep us updated here.
If you are in ACEL this is some good reading : Note this is info from 26 Jun 2007
Public release date: 26-Jun-2007
[ Print Article | E-mail Article | Close Window ]
Contact: Andrew McLaughlin
a.mclaughlin@bath.ac.uk
44-012-253-86883
University of Bath
Frog molecule could provide drug treatment for brain tumors
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Amphinase molecule
Click here for more information.
--------------------------------------------------------------------------------
A synthetic version of a molecule found in the egg cells of the Northern Leopard frog (Rana pipiens) could provide the world with the first drug treatment for brain tumours.
Known as Amphinase, the molecule recognises the sugary coating found on a tumour cell and binds to its surface before invading the cell and inactivating the RNA it contains, causing the tumour to die.
In new research published in the Journal of Molecular Biology, scientists from the University of Bath (UK) and Alfacell Corporation (USA) describe the first complete analysis of the structural and chemical properties of the molecule.
Although it could potentially be used as a treatment for many forms of cancer, Amphinase offers greatest hope in the treatment of brain tumours, for which complex surgery and chemotherapy are the only current treatments.
“This is a very exciting molecule,” said Professor Ravi Acharya, from the Department of Biology & Biochemistry at the University of Bath.
“It is rather like Mother Nature’s very own magic bullet for recognising and destroying cancer cells.
“It is highly specific at hunting and destroying tumour cells, is easily synthesised in the laboratory and offers great hope as a therapeutic treatment of the future.”
Amphinase is a version of a ribonuclease enzyme that has been isolated from the oocytes (egg cells) of the Northern Leopard frog.
Ribonucleases are a common type of enzyme found in all organisms. They are responsible for tidying up free-floating strands of RNA cells by latching on to the molecule and cutting it into smaller sections.
In areas of the cell where the RNA is needed for essential functions, ribonucleases are prevented from working by inhibitor molecules. But because Amphinase is an amphibian ribonuclease, it can evade the mammalian inhibitor molecules to attack the cancer cells.
As a treatment, it is most likely to be injected into the area where it is needed. It will have no effect on other cells because it is only capable of recognising and binding to the sugar coating of tumour cells.
“Amphinase is in the very early stages of development, so it is likely to be several years and many trials before it could be developed into a treatment for patients,” said Professor Acharya and his colleagues Drs Umesh Singh and Daniel Holloway.
“Having said that, the early data is promising and through this study we have provided the kind of information needed if approval for use is requested in the future.”
Amphinase is the second anti-tumour ribonuclease to be isolated by Alfacell Corporation from Rana pipiens oocytes.
The other, ONCONASE(R) (ranpirnase), is currently in late-stage clinical trials as a treatment for unresectable malignant mesothelioma, a rare and fatal form of lung cancer, and in Phase I/II clinical trials in non-small cell lung cancer and other solid tumours.
“We are pleased with the superb work performed by Professor Acharya and his talented team at the University of Bath,” commented Kuslima Shogen, Alfacell’s chairman and chief executive officer.
“Their work is critical to the continued development and understanding of our family of novel ribonuclease based therapeutics with the potential to help patients suffering from cancer and other dismal diseases.”
The company is now working on pre-clinical trials of Amphinase with a view to beginning clinical trials in the future.
###
For further information please contact Andrew McLaughlin in the University of Bath Press Office on +44 (0)1225 386 883 or a.mclaughlin@bath.ac.uk.
Notes
The University of Bath is one of the UK’s leading universities, with an international reputation for quality research and teaching In 20 subject areas the University of Bath is rated in the top ten in the country. View a full list of the University’s press releases: http://www.bath.ac.uk/pr/releases
Links
Department of Biology & Biochemistry http://www.bath.ac.uk/bio-sci
Alfacell Corporation http://www.alfacell.com/
very interesting stock here...any idea when the FDA will make their announcement? tia
should be a winner. motely fool has news on our prince frog.
fda i believe will approve since theres no real side effects.
down the road over 10.00 or perhaps buy out? who knows
I Did
Very strong MA development underway, and just starting to get noticed. Next bit of news should do it.
Please scroll down for both images.
back up the truck
all the info on inv. vil. tells me so
I agree.
This board should become more active with the massive upside stock price potential of ACEL.
It's a bonafide upside breakout now! IMO ...$3.75 within 4 weeks and $10+ by EOY.
GLTA
technically its looking healthy as she can get. approval and we attack 10.00's
each day by day .... thats right
looking healthier each day
we are getting closer , patience was indeed needed here.
echo -echo
no ones here?
shorts came into this taking it down from 2.00 since it tax loss selling season etc
i believe 1.60 may come ,,, safe entry
60% chance of approval
and if approved a big pharma partner to come
so we move to about 5-8 next yr
so you like dkgr? how did you find it,wheres it going
acel is selling down recently,short interest increase
are you in acel or?
thanks Veritas
i wonder about acel since trials have taken so long.yet they have legitamate ceos etc ,perhaps they have a bit of the legend of Thisafis ,the greek god who had to keep pushing rocks up a hill ,over and over . They claim the stock will rocket if approved Watchlist Portfolio Toplists DKGR: Quote - Charts - News - Financials Forex Commodities
Hi lordwinmore,
Welcome to IHUB!
It is a great place to learn AND share with others.
I sold ACEL a while back when I noticed it peaked.
I sold in the $3's.
http://stockcharts.com/charts/candleglance.php?ACEL,ISCR|B|B14
Right now im in another healthcare type stock (ISCR).
http://quotes.barchart.com/quote.asp?sym=iscr
Will be interesting to see what comes of it. Its been highly volatile lately.
With any stock....if your not sure, and are holding shares- reduce your position by half. This will limited your risk.
Its much easier to buy in momentum than to sell in a downward stock. ACEL's last pr said they had a large loss, so I would be cautious. I havent really looked at it myself in a while.
Hope you are well.
Have a nice day. =)
If you want to get back in, consider above $2.18/share.
That CURRENTLY would be OVER 3 MAJOR TRENDLINES. =)
are you still long acel?
insiders havn't sold yet, but i wonder if a few or one of them loans shares out to shorts? just a thought
anyhow, the volumes low and not many bio stock investor forums list acel , seems its been forgotten or just collectin dust on the back burner ,sorta senerio.
any insight would be outofsight(an old phrase)
Hi all, lol!
In today.
See what happens from here on out!
=============================================
ACEL.
http://www.fool.com/investing/small-cap/2007/04/19/5-top-microcap-stocks.aspx
Alright, lastnight/this morning I picked it from merely a chart play.
I just did some DD on it.http://quote.barchart.com/texsnap.asp?sym=ACEL (have a 100% buy)
Turns out it has a (5 star)rating, and insiders hold 50% shares. So, thats good.
Take care. =]
what a chart!!! i'm in at 2.33. Let the good times roll
Looks interesting now - not much volume, but decent gain.
hopefully soon on a run - I prefer selling opportunities to buying opportunities!
one thing to be alert to, especially if you are trading rather than buying and forgetting about it: quick spikes in both directions happen. a GTC sell well above market (or a GTC buy well below) could be rewarding. but stock is thinly traded; recently I had an order for 800 shares at 1.54, got 50 of them - ouch!
Steve thanks, sure looks like a bottom. The question is when is the next run?
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