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I thought the herpes IND submission was supposed to be in August.
The new timeline indicates 4th Q '04 or 1st Q '05. Any comments?
(no trash from LO, however).
Historians out there, What was Cryogenix into before they became Cytogenix? Freeze-dried people?
Will someone write a book on these goings-on when we're all rich & retired? Having only followed this company since last July, I've got no idea what you're all talking about!
Are all markets closed tomorrow?
Great work, arnold. I'm sure it won't shut up LO, but it exposes him once again as a fabricator.
I also e-mailed them asking the same question.
It was basically a give-back. $25K is pocket change and would probably just cover the legal fees.
Such an arrangement would have had to be disclosed, and no suggestion of that was in the last 10K.
Just asking because posters other than LO are worrying that the Hunts might off-load a large block. It would also help shed more light on the motivation behind the Hemco return of their 10% interest in our patents. If the Hunts are still significant shareholders, then the return of the 10% at a low price cannot be construed as a negative, as LO is trying to do. Lastly, I look upon significant Hunt family ownership as being a positive, given their obvious influence in the financial world.
Our resident thespian, Sir L.O., claims the Hunts are no longer shareholders in CYGX (post #8305). Can anyone verify or disprove this?
I think you've hit on the reason in your speculation on the seemingly low price of $25K. If the Hunts own a large number of shares, and the share price is being held down by the lack of operating funds (cash on hand at end of 1st quarter was only $150K), and the investment banks won't throw in money until the 10% ownership issue is resolved, then the Hunts would be cutting off their nose to spite their face if they didn't fix the problem by letting CYGX off the hook cheaply. I would look now for a funding announcement in the near future, and a subsequent pop in SP.
As for ownership of future patents, I think Hemco is out of it. Look at the statement in the 10K:
The Company entered into an agreement with HEMCO Onshore, L.L.C. ("HEMCO") on
April 6, 2001 in order to obtain $250,000 of working capital. The note issued in
exchange for the $250,000 has been paid in full by the Company. Pursuant to this
agreement, the Company assigned to HEMCO an undivided 10% ownership interest in
(i) all of the US and international patents and patent applications owned by the
Company and (ii) any US or international patent obtained, or patent application
filed, after April 6, 2001 based on the intellectual property described in
clause (i) of this sentence. The Company has the right to acquire from HEMCO the
foregoing 10% interest for $1,000,000 until April 6, 2003.
Clause ii states ownership of patents arising out of intellectual property of the original patents at the time.
But I'm not a lawyer, and may be reading this wrong.
Possibly some additional competition coming from my area...I work 2 blocks from this company.
Company News
VICL
Vical Incorporated NASDAQ-NM
Back to Headlines / Previous Story / Next Story
NIH Supports Phase 1 Clinical Trial of Vical's DNA-Based Anthrax Vaccine
SAN DIEGO, June 1 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) announced today that National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH) has advised the company that it will support a Phase 1 clinical trial of the company's investigational plasmid DNA-based anthrax vaccine at two NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). Clinical trial materials are ready for shipment, and the trial is expected to begin within the next few weeks.
"This partnership with NIAID provides funding and advances our anthrax vaccine into human clinical testing," said David C. Kaslow, M.D., Vical's Chief Scientific Officer. "Our bivalent vaccine has the potential to provide broader protection against anthrax than the currently licensed vaccine and potentially superior stability for stockpiling. In addition, this trial provides an opportunity to confirm in humans the potent antibody responses that our vaccine elicited in animal studies."
The VTEUs, established in 1962, are a nationwide network of university-affiliated research hospitals that conduct Phase 1 and Phase 2 clinical trials for NIAID. Through these centers, candidate vaccines of potential public health significance are tested and evaluated for safety and efficacy. The VTEUs have conducted clinical trials of vaccines for numerous infectious diseases, including those that might be introduced through acts of bioterrorism.
About Vical
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has retained all rights to its internally developed product candidates. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about a commitment to funding by the NIAID, the scheduled commencement of clinical trials for the company's anthrax vaccine, the use of Vical's DNA delivery technology in the development of vaccines for anthrax and other infectious diseases, and the potential for Vical's DNA vaccine technology to be applied to anthrax and other infectious diseases, as well as the company's focus, collaborative partners, product candidates, and developmental status. Risks and uncertainties include whether human trials of the company's anthrax vaccine will confirm the antibody responses observed in animal studies, whether vaccines for anthrax or other infectious diseases will be developed and approved, whether use of Vical's technology in such vaccines will provide protective immune responses to such diseases and will result in products that are better than competing products, whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether use of the company's technology will extend to new product opportunities for humans and animals, whether Vical or its collaborative partners will seek or gain approval to market any product candidates, the dependence of the company on its collaborative partners, and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Atkins + Associates
(858) 646-1127 (858) 527-3486
Website: http://www.vical.com
SOURCE Vical Incorporated
-0- 06/01/2004
/CONTACT: Investors - Alan R. Engbring of Vical Incorporated,
+1-858-646-1127; or Media - Susan Neath of Atkins + Associates,
+1-858-527-3486, for Vical Incorporated/
/Web site: http://www.vical.com/
(VICL)
CO: Vical Incorporated
ST: California
IN: BIO MTC HEA
SU: SVY
KJ
-- NYTU032 --
2054 06/01/200408:30 EDThttp://www.prnewswire.com
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A third reason is that institutional investors as a rule can't touch OTCBB listed stocks. Retail buyers alone don't create enough demand.
Suky, do you live in San Diego? If so, give me a call sometime. 858-554-8252. John
Sounds like it's time to load some more on the truck...
If they've found a blood delivery system, that's HUGE news. I wish we'd get a PR about this. This opens up IV treatment and expands the realm of possible target diseases to everything viral and bacterial, not to mention reaching soft-tissue tumors.
Just glancing at his comb-over hair style, I bet he's hoping for a hair regrowth treatment!
VOIP was the cover story article in Barrons this weekend also.
Several companies discussed, no mention of GTEL, but I think they never cover OTCBB companies.
Don't think so, but I'll ask the infectious disease specialist at work. Staph epidermidis is on everyone's skin and nasal passage, where it's kept in check, but it can cause a serious infection internally.
On another topic, I read in an Indian newspaper today that India is rapidly becoming the world's dominant manufacturer of vaccines, including the hepatitis-B, DPT, and measles vaccines. With Phanuel's India division getting started, I could see them leading the way in producing CYGX's oligo's much more cheaply over there.
I too see no problem with knocking off all bacteria. The only part of us that is not supposed to be sterile anyway is the GI tract. The oligo's will go everywhere blood goes, and blood goes to all tissue, bones and teeth included. Restoring the GI flora is not difficult.
So neo, you're saying one formulation kills ALL bacteria? So for treating a systemic bacterial disease, such as sepsis, all pathogenic bacteria, as well as all beneficial bacteria, would be knocked out? Correct? If so, I guess this wouldn't be too harmful to the body as a whole, since our broad spectrum antibiotics pretty much do this anyway. This doesn't jive with Rick's response.
Rick, couple questions...Is CYGX's sepsis treatment specific to a particular organism, or is it effective against all bacteria? If it works against all, then TX could be initiated immediately. If it's organism specific, then a culture would have to be done first, or at least a gram-stain, to get the physician into the ballpark. Also, when human trials begin, will CYGX be forced to run the first trials on the sickest patients, as many new chemotherapy drugs are forced to do?
Thalio, any comments from you on this?
Maybe they'll come up with something to cure finger tremors!!!
If it happened after the end of the quarter, I guess it would appear in the next report. Sure would be nice to get something official, though. We need to hold the .55 level.
While we're in our recliner chairs, how 'bout something new on curing baldness or the common cold? A nasal spray against the rhinovirus would blow us sky-high. So would something topical for baldness. Neither should present much of a problem as far as delivery is concerned. For that matter, how 'bout something for the opposite of baldness, ie hair where people don't want hair? Lots of that out there too, like half the armpits in America. Anyone think it could have this sort of application?
Looks like we're at an important support point. Any TA opinions out there?
An orphan disease is defined in the U.S. as:
o A rare disease that affects fewer than 200,000 people; or
o A common disease that has been ignored because it is less prominent in
the U.S., compared with developing nations.
The U.S. Orphan Drug Act of 1983 offers tax incentives on clinical
trials and seven years' market exclusivity on orphan drugs. Since the Act, more
than 200 orphan drugs have been approved by the FDA and are on the market.
According to the NIH, more than 6,000 so-called orphan diseases exist in the
U.S. With a mere 300 of these diseases being directly addressed in a therapeutic
manner, there is a large need to undergo development programs to counter orphan
diseases like SCD.
Rick, I do think CYGX is at a point of development now in their technology where they could reapply to the Dept of Homeland Security for a grant to study Anthrax, or other biologic agents. It may also qualify for an orphan drug status grant. With their current prelim. success with sepsis, I think the powers that be would be remiss not to fund it. A half mil. or so could get us a couple more researchers and help cover the rent!
I think you will have a very difficult time researching this guy, because there are so many variations on the way Indians transliterate their names into English. There is an Indian Dr who works here with the same first name, but he does not put an "e" at the end. The last name could have multiple spellings also. Chaturvedi is a very common name in India, and is a possible variation.
I don't think any details of the arrangement with Phanuel have ever been made public, so making such an estimate would be impossible. Furthermore, guessing at sales would also be extremely difficult. Having lived in India for 6 years, I know that a majority of the population can't afford to buy medicine anyway, although the once miniscule middle class is expanding rapidly in the urban areas. I think there are now about 30 M cellphone owners now, so if you can afford a cellphone, you could probably affort to treat your herpes. Another factor is that STD's are not as openly acknowledged as they are here. Many sufferers would never admit there was even a problem. Would be great if the Govt. promoted it, like they do birth control.
What's the float on this company?
OT. Outta here for 9 days vacation. Hope to see several new PR's(and higher PPS) on my return. Best to all.
I wish they would focus on M.R.S.A. immediately. Its a huge problem in hospitals. Probably doesn't result in sepsis as much as the Gram neg's, but it is very widespread, and the cost of treatment is huge.
Rick, or anyone else, will the anti-sepsis treatment be effective against a variety of organisms, or only one specific bacterium? I'm wondering if it will work against methcillin-resistant staph-aureus? This is the germ that plagues hospitals, and has to be treated with the strongest available antibiotic, Vancomycin.
Sub-cutaneous injection makes it to the bloodstream, but just more slowly than intramusculary, and much more slowly than intravenously. Many meds in common use are given sub-Q. To me, this indicates they probably have solved the delivery issue. If so, it's a huge advance.
arnold, I read through their site too. Very elegant approach to stopping cancer cells, although it doesn't seem to act with the specificity that CYGX's does( I see a risk of stopping normal cell division too with this therapy). Bottom line though, IMO, most cancers will be curable in another 10 years, since science is learning to stop cellular replication selectively, instead of the medical equivalent of spraying weed killer, which is the approach of current chemotherapy. I know we(CYGX) have farmed out our various development programs to universities working under grants, but the whole process could progress more rapidly with a dozen or more PhD's on staff in Houston. Thalio could make some interesting comments on ArQule. He's been posting on RB's EXTI board. I'll see if I can get him to comment.
Seems like we would not be too far from this sort of deal. We could certainly use 15MM right now to hire some more techs and move things along faster. I wonder what ArQule had to give to Roche in exchange? Also, how does this approach differ from ssDNA?
Reading that makes you even happier you're invested in CYGX!
I'd like to see a quarterly report. None since Nov. 20.
I e-mailed them yesterday, no response yet.
OT...It's truly amazing. Don't think I've ever stayed in a nicer room. It took 10 minutes to walk from the new tower to the meeting room, and I'm told they're adding a third tower.
Also heard the city is running into a serious water shortage.
Eventually the desert will win.