Currently there are two drugs used in AIDS and cancer cachexia- one is
Megace which is a steroidal drug and the other is Serostim, which is a
version of human growth hormone. AVR118 would have to be equivalent or
better than these two drugs for the FDA to look favorably on it as a
valuable new anti-cachexia drug. The ASCO conference results will be
very telling in this regard.
Tells...I've been posting that for quite a while now. The supporters
response to your response will be "but it's non toxic".
rarboston- Megace is taken orally, and that is often seen as
advantageous for patient acceptance and compliance. AVR 118 has to be
injected daily. Serostim, like AVR118, is a peptide and has to be
injected subcutaneously. It is also quite expensive. So AVR118 may have
a cost advantage over Serostim. However, it would have to be superior to
Megace in its effects on weight gain and lean body mass in addition to
being free of toxic effects to gain physician and patient acceptance.
"it would have to be superior to Megace in its effects on weight gain
and lean body mass in addition to being free of toxic effects to gain
physician and patient acceptance."
I absolutely agree and have posted that several times.
domt, I have just recently got back myself but, I can tell you that the
only trial being run right now is the phase I/II salvage therapy for
AIDS trial in Israel. The other trials have been put on hold to conserve
money and apply it to the most promissing issue.
ADVR has recieved funding for 12 million. The second installment was just received the other day. They will receive four equal installments over this year, each quarter.
Dr. James D'Olimpio will be presenting an abstract at the ASCO conferance on the 6th of June. "Anti-cachectic effects of a novel peptide nucleic acid".
I don't expect us to see any sudden rise in the PPS, any time soon. Unless something unexpected happens. JMO
DOMT..we have a new BOSS! the pps is just flying!! actually just
throwing barbs at advr. just hold on hopefully you got in low and wait
and see. 2004 will be the year and if not ill wait 20 more years for
them to start trials in some other country!!! good luck
OT: Re: Naked Shorting
[This FinancialWire News Release appeared on the IMDS board earlier this week]
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StockGate: DTCC Chief Spokesperson Denies Existence of Lawsuit
May 11, 2004 (financialwire.net via COMTEX) -- (FinancialWire) FinancialWire received a confidential email between a reporter and Stuart Z. Goldstein, Managing Director of Corporate Communications for the Depository Trust and Clearing Corp. [DYCC] in which Goldstein was represented as denying that a lawsuit filed by Nanopierce Technologies (OTCBB: NPCT) exists.
The chief spokesperson for the DTCC, whose board of directors represent a who's who of financial entities, including Lehman Brothers (NYSE: LEH), Citigroup / Solomon Smith Barney's Corporate Investment Bank (NYSE: C), and Morgan Stanley (NYSE: MWD), was quoted as stating that the "lawsuit" did not exist and was simply "charges being leveled by internet crackpots."
FinancialWire sent Goldstein a scanned copy of the actual court filing, which occurred April 29 at 12:15 p.m., and asked Goldstein if he or the DTCC still denied its existence or had any comments. No response was received.
A complete copy of the lawsuit has been posted at http://www.investrend.com/Admin/Topics/Articles/Resources/206_1084219273.doc. The full story is at http://www.investrendinformation.com
The lawsuit alleges that the Depository Trust and Clearing Corp. has a lot of reasons, almost one billion of them a year, to keep illegal naked short selling in operation. It was the proverbial shot across the bow by the legendary Houston law firms of Christian, Smith, Wukoson and Jewell, and O'Quinn, Laminack and Pirtle, whose notches already include environmental targets, the breast implant industry and the tobacco industry, all brought to their knees.
In comments to the U.S. Securities and Exchange Commission, C. Austin Burrell, who is providing litigation support and research for the law firms, said that StockGate is more massive than anyone may have imagined. "Illegal Naked Short Selling has stripped hundreds of billions, if not TRILLIONS, of dollars from American investors," and have resulted in over 7,000 public companies having been "shorted out of existence over the past six years." Burrell said some experts believe as much as $3.5 trillion to $4 trillion has been lost to this practice.
He stated that the restrictions on short selling were deliberately put into the Securities Acts of 1933 and 1934 because of the first-hand evidence then available that the "sheer scale of the crashes was a direct result of intentional manipulation of US markets through abusive short selling by a massive conspiracy."
Burrell noted that the 65-lawyer team presided over by lead lawyers Wes Christian and John O'Quinn has uncovered more than 1,200 hedge fund and offshore accounts working through more than 150 broker-dealers and market makers in a joint cooperative effort to strip small and medium size public companies of their value.
Recently the NASD and U.S. Securities and Exchange Commission approved an interim naked short-selling band-aid, requiring U.S. brokers to make an "affirmative determination" that short-sellers, even foreign short-sellers, mostly Canadian, can find certificates to cover before processing the order.
The SEC is considering even more stringent rules under proposed "Regulation SHO," but even before the ink has dried on these orders and proposals, some three dozen of the most "shorted" small public companies listed in the FinancialWire "StockGate 100" were listed on the "wild west" Berlin Stock Exchange, whose executives admitted in an exclusive FinancialWire interview was without their permission or authorization. This allows market manipulators the benefit of the "arbitrage" loophole that none of the present regulations or proposals aim to fill. Among the most recent demanding "delisting" from the Berlin exchange include BGR Corp. (OTCBB: BGRR), Advanced ID Corporation (OTCBB: AIDO), Goldspring Inc. (OTCBB: GSPG), Whistler Investment (OTCBB: WHIS), and Datascension, Inc. (OTCBB: DTSN). Berliner Freiverkehr (Aktien) AG has been singled out as the broker and market maker that has been "listing" the companies. It is suspected that one broker, RA Angsar Limprecht, is involved in all if not most of the listings.
The SEC band-aid hasn't been entirely effective, either. As late as Sunday, May 9, one of the most outspoken thorns in the side of the NASD and SEC over the naked short-selling scandals, small investor Dave Patch, was still demanding shares of Datascension a month after Al Laubenstein, Compliance Director for Computer Clearing Services had emailed him that it had "issued a buy-in notice." On April 21, Laubenstein wrote Patch that it's buy-in notice "was not accepted by the seller, as they reportedly have certificates in transfer. As you are no doubt aware, all of the issuers in question have unusual registration policies which impede the settlement process between firms. While we regret these delays, given the circumstances, they are not unexpected." Patch has complained to the SEC and NASD that he has lost 50% of his value while his shares are in limbo, although the money for the shares had been extracted from his account and are being used by the broker.
Last year, many besieged public companies sought refuge from the manipulation by seeking to exit the DTC, but on June 4, 2003, the SEC stated "the issues surrounding naked short selling are not germane to the manner in which DTC operates as a depository registered as a clearing agency. Decisions to engage in such transactions are made by parties other than DTC. DTC does not allow its participants to establish short positions resulting from their failure to deliver securities at settlement. While the Commission appreciates commenters' concerns about manipulative activity, those concerns must be addressed by other means."
The Nanopierce lawsuit, said to be the first of many out of the box, emphatically suggests otherwise. According to lawyer Christian, et.al., the DTC is at the very heart of the problem, and has almost a billion dollars a year at stake in keeping the problem.
The Depository Trust Company (DTC) is a member of the U.S. Federal Reserve System, a limited-purpose trust company under New York State banking law and a registered clearing agency with the SEC. The depository supposedly brings efficiency to the securities industry by retaining custody of some 2 million securities issues, effectively "dematerializing" most of them so that they exist only as electronic files rather than as countless pieces of paper. The depository also provides the services necessary for the maintenance of the securities it has in "custody."
The largely unregulated DTC has become something of a defacto Czar presiding over the entire U.S. markets system, wielding more day-to-day influence and control than the SEC, the NASD and NASDAQ combined. And, as the SEC's June 4 ruling indicates, its monopoly over the electronic trading system appears even to be protected.
How entrenched is the Depository Trust and Clearing Corp.? It's two preferred shareholders are the New York Stock Exchange and the NASD, a regulatory agency that also owns the NASDAQ (OTCBB: NDAQ) and the embattled American Stock Exchange! Regulators, regulate thyself?
In an era when corporate governance is the primary interest for the SEC and state regulators, the DTCC is hardly a role model. Its 21 directors represent a virtual litany of conflict:
They include Bradley Abelow, Managing Director, Goldman Sachs (NYSE: GS); Jonathan E. Beyman, Chief Information Officer, Lehman Brothers (NYSE: LEH); Frank J. Bisignano, Chief Administrative Officer and Senior Executive Vice President, Citigroup / Solomon Smith Barney's Corporate Investment Bank (NYSE: C); Michael C. Bodson, Managing Director, Morgan Stanley (NYSE: MWD); Gary Bullock, Global Head of Logistics, Infrastructure, UBS Investment Bank (NYSE: UBS); Stephen P. Casper, Managing Director and Chief Operating Officer, Fischer Francis Trees & Watts, Inc.; Jill M. Considine,Chairman, President & Chief Executive Officer, The Depository Trust & Clearing Corporation (DTCC);
Also, Paul F. Costello, President, Business Services Group, Wachovia Securities (NYSE: WB); John W. Cummings, Senior Vice President & Head of Global Technology & Services, Merrill Lynch & Co. (NYSE: MER); Donald F. Donahue, Chief Operating Officer, The Depository Trust & Clearing Corporation (DTCC); Norman Eaker, General Partner, Edward Jones; George Hrabovsky, President, Alliance Global Investors Service; Catherine R. Kinney, President and Co-Chief Operating Officer, New York Stock Exchange; Thomas J. McCrossan, Executive Vice President, State Street Corporation (NYSE: STT); Eileen K. Murray, Managing Director, Credit Suisse First Boston (NYSE: CSR); James P. Palermo, Vice Chairman, Mellon Financial Corporation (NYSE: MEL); Thomas J. Perna, Senior Executive Vice President, Financial Companies Services Sector of The Bank of New York (NYSE: BNY); Ronald Purpora, Chief Executive Officer, Garban LLC; Douglas Shulman, President, Regulatory Services and Operations, NASD; and Thompson M. Swayne, Executive Vice President, JPMorgan Chase (NYSE: JPM).
In their comments to the SEC regarding Regulation SHO in January, the 50 state regulators, through their association, the North American Association of Securities Administrators (NASAA) issued what many consider to be a strong warning that if the DTC is not dealt with in the final regulations, state regulators such as New York State Attorney General Eliot Spitzer may step to the plate.
In what many considered to have been explosive comments, Ralph Lambiase, NASAA president and Director of the Connecticut Division of Securities, warned "NASAA urges the Commission to reconsider its stance regarding the role of the Depository Trust and Clearing Corporation (the DTC). As a threshold matter, NASAA believes that the Commission should explicitly prohibit the DTC from lending more shares of a security than it actually holds. The ability of the overall proposed rule would be severely impared unless the Commission undertakes to implement such a prohibition."
As the Nanopierce lawsuit reveals, those were indeed strong words, meddling as it did, in a substantial revenues base for the DTCC.
According to the suit, the DTCC has an enormous pecuniary and conflicted interest in the entire short selling scandal through the huge income stream they were realizing from it every day. They have made literally billions of dollars lending individual real shares, in most cases over and over, getting a fee each time they made a journal entry in the "Stock Borrow Program."
The Stock Borrow Program was purportedly set up to facilitate expedited clearance of stock trades. Somewhere along the line, the DTCC became aware that if it could lend a single share an unlimited number of times, it could collect a fee each time, according to Burrell. "There are numerous cases of a single share being lent ten or many more times," giving rise to the complaint that the DTCC has been electronically counterfeiting just as was done via printed certificates before the Crash.
"Such re-hypothecation has in effect made the potential 'float' in a single company's shares virtually unlimited and the term 'float' meaningless. Shares could be electronically created/counterfeited/kited without a registration statement being filed, and without the underlying company having any knowledge such shares are being sold or even in existence." Burrell said the Christian/O'Quinn lawsuits will seek to show that the "counterfeiting/creation of unregistered shares is a specific violation of the Securities Act of 1933, barring the 'Sale of Unregistered Securities'."
While the Nanopierce lawsuit has been filed at the state level, another companion lawsuit just heading to the courts on behalf of Exotics.com (OTC: EXII) will be argued at the Federal level.
Nanopierce's suit in the 2nd Judicial District Court in Nevada, is Case No. CV04-01079, alleges that the DTC's "stock borrow program" was "purportedly created to address SHORT TERM delivery failures," but that the "end result of the program has been to create tens of millions of unissued and unregistered shares to be traded in the public market," and in some instances resulting in "two or more shareholders who purchase shares in separate transactions to own the same shares."
The complaint alleges that the DTC has a colossal disincentive to stop the "stock borrow" program, booking revenues from services of $425,416,000 and similarly, the NSCC deriving revenues of $293,133,000.
Further, the suit alleges that "open positions" resulting from this activity at the close of business on December 31, 2003, "approximated $3,025,467,000" due to NSCC, and $2,303,717,000 due by NSCC, and unsettled positions of $721,750,000 for securities borrowed through the NSCC's "Stock Borrow Program."
Nanopierce claims that DTCC and NSCC have joined in a "scheme" to "manipulate downward the price of the affected securities, thereby reducing the market value of the open fail to deliver positions." The suit also claims that the defendants have permitted sellers to maintain open fail to deliver positions of tens of millions of shares for periods of a year and even longer.
It quotes the National Association of Security Dealers as admitting that "concerns have been raised by members, issuers, investors and other interested parties about potentially abusive short selling activities occurring in the marketplace. In particular, naked short selling, or selling short without borrowing securities to make delivery, can result in long term failures to deliver, including aggregate failures to deliver that exceed the total float of a security. NASD believes such extended failures to deliver can have a negative effect on the market. Among other things, by not having to deliver securities, naked short sellers can take on larger short positions than would otherwise be permissible, which can facilitate manipulative activity."
Nanopierce claims that it had "relied on material misrepresentations and omissions by DTC and NSCC in trading its shares in the stock market "without knowledge of Defendants' fraud-on-the market through statements they made about the clearing and settlement services they provided." Further, it claims that the Defendants acted with "scienter" since they had a major financial financial motivation to falsely represent their services, which Nanopierce claims are also anticompetitive.
Greed, power, dishonesty. It's amazing what money can do to people.
Maybe it's just the lack of compassion. I don't know Shaggy, makes me
feel a bit ill.
"Such re-hypothecation has in effect made the potential 'float' in a single company's shares virtually unlimited and the term 'float' meaningless. Shares could be electronically created/counterfeited/kited without a registration statement being filed, and without the underlying company having any knowledge such shares are being sold or even in existence."
Shaggy. Thats who the paid bashers work for.
Bashers & Pumpers easy answer.
Bashers, Top Management in the last 20 years. Actions speak louder than words.
Pumpers, those who bought shares in that timeframe. Actions speak louder than words.
Saying gooooooooooooo ADVR does not make one a pumper just the same as questioning management decisions doesn't make one a basher.
Smarties. Those that stayed away, traded, or got out and put their money to work elsewhere. Mostly I belong to none of those groups. Unfortunately so far!
Of course that is jmo.
(Voluntary Disclosure: Position- Long)
Bregman. You are as much an idiot as your boy Mark. You must be insane.
Hirschman? Wasn't he your Golden Boy. Wasn't he your Hope? Keep pipin
you old fart. You must be stupid!
Zenna: Sure Bios are the place to be if anything is.
During this decade the baby boomers are moving from their 50s into their 60s. Anti-aging along with wellness technology will grow to a trillion dollars industry by the end of the decade.
My only worry is the stock market in general.
Fender had an excellent 3-part article on this today entitled: "Market Bound By Fear".
This is the problem. Rising interest rates, soaring gas prices, the War in Iraq, the growing quagmire that we're in, etc., etc., etc..
There's so much uncertainty in today's times that THIS is what I'm concerned with.
More than a little frightening!
5/15/04 10-Q has been filed:
STATUS OF CLINICAL TRIALS IN ISRAEL
The Company is currently testing injectable AVR118 in a Phase I/II study in Israel involving cachectic AIDS patients who may or may not be receiving anti-retroviral therapy or highly active anti-retroviral therapy (HAART). The Company’s objective for this study is to determine the safety and tolerability of AVR118. Although there can be no assurances, the Company anticipates that the clinical trials in Israel will help facilitate the planned investigational new drug (IND) application process for injectable AVR118 with the FDA.
In August 2003, the Company decided to defer the continuation of, and re-examine the procedures, protocol and objectives of, two other clinical trials in Israel using AVR118, a Phase I study for cachectic patients with leukemia and lymphoma and a Phase I study for cachectic patients with solid tumors. There can be no assurances as to when these two studies will be completed, if at all.
Because of the Company’s limited personnel, the Company believed it to be in its best interests to focus its clinical efforts on its one ongoing Phase I/II open-label dose-escalation clinical trial being conducted at The Kaplan Medical Center in Rehovot, Israel of AVR118 for cachectic patients with AIDS. Out of 30 total patients contemplated under the protocol for this study, 23 patients are enrolled, all of whom have completed the full course of treatment of AVR118. Interim results from the first 15 patients showed improvement in appetite, weight gain or stability, and enhanced quality of life. None of the first 15 patients reported any serious side effects associated with AVR118 therapy.
The Company estimates that enrollment of patients in this study will be completed during the second quarter of 2004. The study requires a two-week pre-treatment period, a four-week treatment period and a four-week follow-up period. It is estimated that all patients will have completed treatment and follow-up by the third quarter 2004. The completion of the study is dependent upon the availability of patients meeting the prescribed protocol and the ability of the hospitals to meet the requirements of the protocol. From inception of all the clinical studies in Israel through March 31, 2004, the Company has expensed approximately $2,029,000. The cost to complete the Phase I/II study in Israel of AVR118 for cachectic patients with AIDS is estimated to be $261,000. In addition, the Company believes it will incur an additional $150,000 for consulting expenses in the U.S. related to the analysis of data from this Phase I/II study as well as strategic consulting.
In April 2001, the Company formalized a 12-month agreement with Selikoff Center in Israel to develop clinical trials in Israel using AVR118, which arrangement has concluded. As of March 31, 2004, the Company had paid $242,000 for such research.
In September 2002, the Company entered into a contract with EnviroGene LLC, an affiliate of the Selikoff Center, to conduct, evaluate and maintain the scientific quality for the three clinical studies listed above. Under the terms of this agreement, EnviroGene will (1) finalize all Israeli government and hospital approval documents, (2) complete and organize the three clinical trials including establishing a network of scientists to perform said study/trial and initiate recruitment of patients and (3) perform the studies/trials and evaluate the results. Total costs for EnviroGene LLC in connection with these three clinical trials are $1,551,000, of which approximately $1,323,000 has been expensed and approximately $875,000 has been paid through March 31, 2004.
In October 2002, the Company entered into an agreement with Quintiles Israel Ltd. to act as the auditor and monitor of the clinical studies. The agreement terminates upon completion of the services unless terminated earlier by either party upon prior written notice or upon a material breach and a failure to cure, and upon such termination, the Company retain all rights to the research performed under the agreement. The Company has expensed $166,000 since inception of the contract through March 31, 2004. If all three clinical studies in Israel were concluded, the additional cost under this contract would be $87,000. The Company cannot at this time determine the financial impact of reducing the number of trials under this contract.
In November 2002, the Company entered into an agreement with Kaplan Medical Center in Israel to act as the center for the Phase I/II study using AVR118 for cachectic patients with AIDS. The agreement terminates upon conclusion of the study, or upon prior written notice, and upon such termination, the Company retains all rights to the research performed under the agreement. To date, 23 patients have been enrolled in the study out of 30 patients contemplated under the study protocol, and the estimated completion date for the study is the third quarter of 2004. The Company has expensed $133,000 since inception of the contract through March 31, 2004.
Conducting the clinical trials of AVR118 will require significant cash expenditures. AVR118 may never be approved for commercial distribution by any country. Because the Company’s research and development expenses and clinical trial expenses will be charged against earnings for financial reporting purposes, we expect that losses from operations will continue to be incurred for the foreseeable future. We currently do not have sufficient funds to complete all phases of clinical trials of AVR118. We are attempting to secure funds through the sale of the Company’s securities.
The studies being conducted in Israel are subject to risks associated with the political, economic and military conditions affecting Israel and the Middle East, and recent world events, including terrorism and war, have made it difficult to predict whether or in what manner these problems will be resolved.
The Company’s studies detailing the results of the research and testing being conducted in Israel may not positively impact the FDA’s decision to approve a new IND for injectable AVR118 or approve the marketing, sales or distribution of AVR118 within the United States, and as a result may not improve the Company’s chances of gaining approval for the marketing, sales or distribution of AVR118 anywhere in the world. The Company cannot provide assurances that it will acquire additional financial resources to complete all phases of the clinical trials, or, if it acquires such resources, that it will do so on favorable terms.
OTHER RESEARCH AND DEVELOPMENT ACTIVITIES
In March 2004, the Company retained the services of MediVector, Inc. (a biopharmaceutical consulting firm) to perform data management, statistical analysis and report writing for the Israeli clinical trials and patient experiences in Argentina.
In April 2004, the Company appointed Carol Epstein, MD, a co-founder of MediVector, Inc. as acting Medical Director. In this newly appointed position, Dr. Epstein will help guide the Company in the clinical development of AVR118, including choice of clinical indications, design and preparation of protocols for clinical trials, analysis of compiled data, the processing of adverse events in clinical trials, writing clinical sections of the IND and meeting with the FDA.
HAWKINS EMPLOYMENT AGREEMENT
Pursuant to an Employment Agreement dated February 10, 2004, the Company engaged Elma S. Hawkins, Ph.D., MBA to be its President and Chief Executive Officer on a full time basis commencing February 18, 2004 until February 2006 unless terminated earlier as provided in the agreement. The initial term may be extended for successive one (1) year periods unless either party gives the other thirty (30) days prior written notice of its intent not to renew prior to the expiration of the then current term. Dr. Hawkins shall receive a base salary of $350,000 per year, and is eligible to receive an annual cash bonus of up to 50% of her then base salary based on certain performance objectives in the sole discretion of the Board of Directors. In addition, the Company paid Dr. Hawkins a signing bonus of $50,000. The agreement also entitles Dr. Hawkins and her dependents to participate in all incentive, savings and retirement plans, practices, policies and programs applicable generally to other executives of the Company and their dependents. The agreement further provides that:
• The Company shall pay the dues of such professional associations and societies of which Dr. Hawkins is a member in furtherance of her duties.
• The Company shall reimburse Dr. Hawkins for reasonable expenses relating to professional licenses, entertainment, travel and similar items in accordance with the policies, practices and procedures of The Company.
• The Company shall furnish Dr. Hawkins with an automobile and pay all expenses related to such automobile for use in the performance of her duties, or, at the Company’s discretion provide, at its expense, car transportation between New York City and the Yonkers, New York headquarters.
• Dr. Hawkins will be entitled to four (4) weeks paid vacation annually or such other time as authorized by the Board of Directors during which time her compensation shall be paid in full. Vacation Days unused in any calendar year may not be accumulated and carried forward and used in future years.
If the agreement is terminated by the Company for cause, or Dr. Hawkins voluntarily resigns, becomes disabled or dies, then Dr. Hawkins or her estate shall be entitled to her base salary earned through the date of termination, accrued vacation and all applicable reimbursements due. If the agreement is terminated for other reasons by either party, Dr. Hawkins shall be entitled to, in one lump sum payment, that amount which is equivalent to her base salary paid for the fiscal year immediately prior to her termination, and all applicable reimbursements due. Payment of the lump sum severance benefit is conditioned upon the release by Dr. Hawkins of the Company, to the maximum extent permitted by law, from any and all claims she may have against the Company that relate to or arise out of her employment or termination of employment.
Pursuant to the agreement, Dr. Hawkins received an option to purchase 40 million shares of common stock through February 2009. The option vests in increments of 666,667 on a monthly basis, and is exercisable at five different prices, as follows: (i) $0.12 for the first 8 million option shares; (ii) $0.129 for the next 8 million option shares; (iii) $0.139 for the next 8 million option shares; (iv) $0.149 for the next 8 million shares and (v) $0.160 for the last 8 million option shares. If Dr. Hawkins is terminated for cause or if she voluntarily resigns without cause, the option shall expire for all option shares which have as of such date not become exercisable but shall survive with respect to option shares that have become exercisable as of such date, (the “Surviving Options”), provided, she shall have 90 days to exercise the Surviving Options. Upon the termination of Dr. Hawkins’ employment for other reasons, the option shall immediately become exercisable for that number of option shares equal to the number of option shares which would have been subject to exercise by Dr. Hawkins during the then current term of the employment agreement (without giving effect to any extensions thereof).