By: pennyman4
01 Dec 2004, 12:18 AM EST
Msg. 177182 of 188686
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The news was awesome but totally expected.....better early than late. In the last and only recent conference call our CEO stated she would be filing a Phase 2 application. The pre-filing meeting stated late 2004 or early 2005.
After the 30 days is up I am looking for more info. I want to hear about the protocol for the study and that we have enough money to complete the study. If we make it know that we don't have to scramble for money then investors...large, institutional investors know they should tune in. Because if our drug works, and most of us multi-year maniacs believe it does, we will sign a partnership deal before phase 2 is complete.
We have millions in the bank.......don't sell us out for peanuts now...phase2 shows our worth..wait! JMHO!
 
By: ricka6548
01 Dec 2004, 07:18 AM EST
Msg. 177186 of 188686
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NEWS IS OUT!!!!!!!
 
By: SUE32073
01 Dec 2004, 10:13 AM EST
Msg. 177216 of 188686
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Hmmmmm....perhaps the PR concerning CANCER-something-or-other wasn't specific enough!...LOL. I have learned over the years as an ADVR shareholder, not to take "anything" for granted.....! "I Just Can't Get Nooooo, Satisfactshun"!!!

 
By: DIAMONDring
01 Dec 2004, 03:44 PM EST
Msg. 177300 of 188686
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NEWS advr to present on sesame street. elma states i cant wait to talk about avr 118 with big bird!
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By: cecilk
01 Dec 2004, 06:55 PM EST
Msg. 177340 of 188686
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ADVR to Present at the 2005 Annual Assembly of the AAHPM and HPNA
12/1/04


YONKERS, N.Y., Dec 1, 2004 (BUSINESS WIRE) --
ADVR will Report Results on its Phase I/II Clinical Trial of AVR118 in Patients with AIDS

Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) today announced that James T. D'Olimpio, M.D., has been invited to give an oral presentation at the 2005 Annual A
ssembly of the American Academy of Hospice and Palliative Medicine (AAHPM) and Hospice and Palliative Nurses Association (HPNA) to be held January 19-23, 2005, in New Orleans, LA.

Dr. D'Olimpio will deliver an oral presentation entitled, "Efficacious Reversal of AIDS Related Anorexia/Cachexia Syndrome: Final Results of a Phase I/II Study Using a Novel Peptide-Nucleic Acid Complex." The presentation is scheduled for 10:00 a.m. on January 22, 2005.

The presentation will report final results on the Phase I/II clinical trial of AVR118 in patients with AIDS. The 30-patient trial was conducted at the Kaplan Medical Center in Israel in cachetic AIDS patients.

"We are delighted that our abstract has been selected to be given as an oral presentation at such a prestigious conference," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "The joint meeting of the AAHPM and HPNA is the premier meeting of palliative medicine and all presentations given at the conference are selected based on peer review."

The American Academy of Hospice and Palliative Medicine (AAHPM) is the only organization in the United States for physicians dedicated to the advancement of hospice/palliative medicine, its practice, research and education. AAHPM members are physicians and other healthcare professionals from many medical specialties who are committed to furthering and fostering the practice of hospice/palliative care for the terminally ill and their families.

ADVR's AVR118 is a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which, to date, has demonstrated a very favorable safety profile, appears to stimulate the pro-inflammatory responses required to combat viral infections such as HIV and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Data presented at the American Society of Clinical Oncology's (ASCO) annual meeting in June, 2004, showed that AVR118 appears to have activity against fatigue, loss of appetite, and weight loss in patients with HIV.

For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com. ADVR, based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases.




(Voluntary Disclosure: Position- Long; ST Rating- Strong Buy; LT Rating- Strong Buy)

 
By: dirtysneakers0
02 Dec 2004, 02:28 PM EST
Msg. 177411 of 188686
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Phase II should begin on or about Dec 26, if all goes according to plan.
By: dirtysneakers0
02 Dec 2004, 02:39 PM EST
Msg. 177414 of 188686
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When the IND is accepted. We have money to get Phase II started. IMO if early result are promising we will get financing.

 
By: dirtysneakers0
02 Dec 2004, 03:10 PM EST
Msg. 177425 of 188686
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Hopefully Elma and AVR118 can take advantage of the following:

Promising Experimental Drugs


Eight years is a long time to review a drug. Some patients, especially terminally ill patients, don't particularly care if the drug meets high standards of safety. They don't have the time. Taking any drug, in their view, is better than the alternative. So today's policies also allow some investigational drugs even before they are approved for marketing.


These new policies called "expanded access" protocols include the Treatment Investigational New Drug (IND) application and the parallel track mechanism. Both tracks allow promising drugs, not yet approved for marketing, to be used in moderately unrestricted studies where the intent is not only to learn more about the drug, especially about its safety, but also to provide treatment for people with no real alternative. But these expanded access protocols still require clinical researchers to formally investigate the drug in well-controlled studies and to supply some evidence that the drug is likely to be helpful.



Final Actions


The FDA's decision whether to approve a new drug for marketing comes down to answering two questions:

1. Do the results of well-controlled studies provide substantial evidence of its effectiveness?

2. Do the results show that the product is safe under the explicit conditions of use in the proposed labeling? Here "safe" is a relative term; it means that the benefits of the drug appear to outweigh its risks.


When the review is complete, the FDA writes to the applicant to say the drug is either approved for marketing, is "approvable," provided minor changes are made, or is not approvable because of major problems. In the last case, the applicant can then amend or withdraw the NDA or ask for a hearing. Once its NDA is approved, a drug is on the market as soon as the firm gets its production and distribution systems going.

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By: pennyman4
02 Dec 2004, 11:36 PM EST
Msg. 177492 of 188686
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It would be a real show of confidence if our CEO and maybe some board members start purchasing some of their shares. At .10 she will be automatically up over 30%. If this starts.....small amounts is fine but starts in one to six months time frame I think it really helps us. JMHO
 
By: kevtod
03 Dec 2004, 02:38 PM EST
Msg. 177556 of 188686
(This msg. is a reply to 177547 by SUE32073.)
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This "Phase II"...2-3 Years...IMO...eom
By: kevtod
03 Dec 2004, 02:40 PM EST
Msg. 177558 of 188686
(This msg. is a reply to 177556 by kevtod.)
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Still 2010 for AVR118 to market....

IF all goes well....

IAG.....-kevtod

 
By: kevtod
03 Dec 2004, 02:43 PM EST
Msg. 177559 of 188686
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FDA Clears CoFactor to Begin Second Stage of Phase II Clinical Trial for Metastatic Colorectal Cancer



SAN DIEGO--(BUSINESS WIRE)--Nov. 2, 2004--ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that it has been granted allowance by the Food and Drug Administration (FDA) to begin recruiting patients for the second stage of its Phase II trial using CoFactor(TM) to modulate the effect of 5-fluorouracil (5-FU) for metastatic colorectal cancer. The Company reported available clinical data to the FDA related to the 23 initial patients recruited as part of the Simon Two-Stage trial design. Based on this submission, the FDA granted the Company authorization to proceed to the second stage of the study and enroll an additional 25 patients.

The Phase II trial of CoFactor is an open-label single arm study to evaluate safety, tumor response, time-to-tumor-progression and overall survival in patients treated with CoFactor and 5-FU. Eligible patients for this study have surgically incurable, metastatic colon or rectal adenocarcinoma, and no prior chemotherapy for metastatic disease.

"We are extremely pleased to receive the go-ahead from the FDA to advance CoFactor to the second stage of the Phase II clinical trial," said Cellia Habita, M.D., Ph.D., Vice President of Clinical and Medical Affairs for ADVENTRX. "At this rate, we currently anticipate completing total patient enrollment by the end of 2004 and reporting results in the spring."

The Company currently plans to file in 2004 in the European Union and in 2005 in the US for clearance to begin randomized controlled Phase II multicenter metastatic colorectal cancer trials. In addition, the Company currently intends to file with the FDA and the European Medicines Agency (EMEA) in the first quarter of 2005 to begin trials for treatment of patients with advanced pancreatic cancer in both the US and EU. In October 2004, the FDA and EMEA each granted the Company orphan drug status for CoFactor for the treatment of pancreatic cancer in the US and EU, respectively.

About CoFactor

CoFactor (5,10-methylenetetrahydrofolate) is a biomodulator designed for use with 5-FU, a commonly used cancer drug. CoFactor is the active metabolite of leucovorin that bypasses the chemical pathway required by leucovorin to deliver the correct form of folate to cancer cells, allowing 5-FU to work more effectively. In previous Phase II trials in Europe, CoFactor was administered to metastatic colorectal cancer patients 20 minutes before intravenous administration of 5-FU. In these European trials, CoFactor improved survival and time-to-tumor-progression while lowering toxicity in metastatic colorectal cancer patients.

About ADVENTRX

ADVENTRX Pharmaceuticals, Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company focuses on cancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. More information on ADVENTRX can be found on www.adventrx.com.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the United States Food and Drug Administration and other regulatory agencies. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.


CONTACT: ADVENTRX PharmaceuticalsAndrea Lynn, 858-552-0866
or
CEOcast, Inc.
Kevin Theiss, 212-732-4300

SOURCE: ADVENTRX Pharmaceuticals, Inc.

**********************************************************

FYI.....-kev

 
By: DIAMONDring
04 Dec 2004, 11:21 AM EST
Msg. 177671 of 188686
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FOX china has used avr 118 with great results but elma has it filed in the drawer marked ARGENTINA results. (if you no what i mean)
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