Cobalis Corp, extrem interessanter Bio Tech Play mit Riesen Markt - 500 Beiträge pro Seite

[GoofMan]

Hallo,

hier erst mal die heutige News zu Cobalis:

Cobalis Completes Funding; Expects Top-Line Phase III Trial Results for PreHistin(TM) in April 2007
Thursday March 22, 6:36 am ET

IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corp. (OTC BB: CLSC - News) a pharmaceutical development company specializing in anti-allergy medications, announced today that it has completed its $3.85 million funding with the receipt of gross proceeds of $675,000 from the third and final closing under its Security Purchase Agreement dated December 20, 2006. The final closing was funded after the Securities and Exchange Commission declared the Company's related Registration Statement was effective.

A portion of the proceeds from the third closing will be utilized to complete data analysis required for reporting top-line efficacy results from the Company's twin pivotal Phase III Clinical Trials for its anti-allergy medication, PreHistin(TM). The twin trials are completed, and all of the data from the 23 sites has been collected and is being audited. Cobalis anticipates that the database will be "locked" shortly, with analysis of top line efficacy results to be completed and announced in April 2007.

Cobalis Corp. Chief Executive Officer Dr. Gerald Yakatan said, "We are pleased to have completed this financing and look forward to our next major corporate milestone, reporting top-line efficacy results from our allergy trials. After the results are known, the Company will be in a better position to decide its direction regarding our regulatory approval plan and our strategy with potential marketing partners."

Phase III Clinical Trial Overview:

The Phase III Clinical Trials involved 1,551 patients at 23 sites across the central, southern and eastern United States. The patients received either placebo or a 3.3 mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. The trials were designed to test the safety and efficacy of pre-seasonal treatment with PreHistin on moderate to moderately severe seasonal ragweed allergy patients. Symptom diaries were maintained for an additional four weeks following treatment to determine duration of effect. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US.

About Cobalis Corp.

Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy prevention medication in Phase III clinical development. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com


Das Antiallergiemittel von denen soll die Ursachen von Allergien angehen, nicht nur die Syptmome bekämpfen. Der Markt für Allergiemittel ist riesig. Mit diesem Trial können sie nun das FDA Approval in USA angehen.

Ich halte den wert für sehr interessant, wenn das durchgeht wie die das planen sind viele 100% drin.

Wie immer bei den kleinen Biorechs ist natürlich auch ein Totalverlust möglich, also seid vorsichtig.

[newzealaender]

[GoofMan]

Press Release Source: Cobalis Corp.

Cobalis Locks Database for Pivotal Twin Phase III Trials of PreHistin(TM) in Seasonal Allergic Rhinitis
Thursday March 29, 6:36 am ET

IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corp. (OTC BB: CLSC - News), a pharmaceutical development company specializing in anti-allergy medications, today announced that it has completed the locking of the database for its pivotal twin Phase III Clinical Trials of PreHistin(TM) in seasonal allergic rhinitis. An independent contract research organization (CRO) will now begin the process of implementing the statistical analysis plan designed to analyze the data from the pivotal trials.

"We are pleased to have reached this milestone in our PreHistin trials and look forward to reporting top-line results over the next month," commented Dr. Gerald J. Yakatan, Chief Executive Officer for Cobalis Corp. "These twin trials represent two of the largest clinical trials conducted utilizing this novel anti-allergy approach. Our goal is to be able to offer a new, over-the-counter anti-allergy treatment option for allergy sufferers that goes beyond currently available remedies."

The 1,551-patient pivotal Phase III trials investigated the efficacy and safety of treatment with Cobalis' PreHistin on moderate to moderately severe seasonal ragweed allergy patients. The twin trials were designed to support regulatory approval in the United States and key global markets. The studies' primary endpoint is the average improvement in total nasal symptom score (TNSS) in weeks four, five and six of treatment. To observe duration of effect after treatment, patients maintained diaries for symptomology over the final four weeks of the ten-week study.

About Seasonal Allergic Rhinitis

Seasonal allergic rhinitis is a condition that causes allergy symptoms such as sneezing, runny nose, and nasal congestion. It is believed that people with allergies produce too much IgE (immunoglobulin E). Elevated levels of IgE trigger a release of histamine, which causes common allergy symptoms. Lowering IgE levels helps to prevent the creation and release of histamine. We believe that past research has demonstrated that cyanocobalamin, the active ingredient in PreHistin, reduces IgE. It is estimated that in the United States alone, seasonal allergic rhinitis affects approximately 36 million people, with related healthcare costs exceeding $7 billion annually. Currently available OTC remedies relieve symptoms on a temporary basis and treat symptoms only after they appear, while also often creating significant adverse side effects including drowsiness and sedation. PreHistin is designed to be a non-drowsy, non-sedating pre-seasonal allergy treatment targeted for OTC distribution.

About Cobalis Corp.

Cobalis Corp. is a specialty pharmaceutical development company specializing in medications to prevent and treat atopic disease, including allergies, migraine headache, atopic asthma and dermatitis. Its flagship drug candidate PreHistin is an allergy medication in Phase III clinical development. Cobalis plans to seek FDA approval to market PreHistin over-the-counter in the US. For further information, visit www.cobalis.com

Safe Harbor

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cobalis disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company's clinical development of its drug candidates, the potential benefits of the Company's drug candidates and the size of the potential market for the Company's products. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to securing funding for ongoing operations including clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the development of competing products by our competitors; uncertainties related to the Company's dependence on third parties and partners; and those risks described in our quarterly report on Form 10-QSB filed with the SEC on February 20, 2007.


Contact:

Jaffoni & Collins Incorporated
David Collins or Steven Hecht, 212-835-8500
[e-mail]

[GoofMan]

Antwort auf Beitrag Nr.: 28.434.285 von newzealaender am 22.03.07 16:07:40

Hmm aktuell in USA +18% mit Volumen, immer noch am Lachen?

[GoofMan]

Ich korrigiere mich auf 30%....

[XIO]

RESPEKT

[Poppholz]

Kurssteigerungen sind ja leider schon lange her.

Ist hier noch eine Chance auf einen Kursanstieg?

Was meint Ihr?

[Poppholz]

Antwort auf Beitrag Nr.: 30.611.678 von Poppholz am 10.07.07 12:25:56

die aktuellen News:

Low pollen count disrupts Cobalis' hayfever trial
9th July 2007
By Sarah Routledge

Cobalis has reported that in two phase III trials for PreHistin in patients with hayfever, very low symptom levels were found in both the PreHistin and placebo-treated groups, leaving no room to demonstrate a meaningful drug effect.
In the randomized, six week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin did not achieve statistically significant differences from placebo in the primary measure of efficacy, the reduction in total nasal symptom score (TNSS). However, the TNSS data for placebo-treated patients was far lower than would be expected for the moderate to moderately severe patient population called for in the protocol.

Low pollen counts in many of the regions during the time PreHistin was being tested may have resulted in low mean placebo symptom scores for the overall study population, the company said. The trials showed that PreHistin was well tolerated, contributing positively to the safety record of PreHistin's active ingredient, cyanocobalamin.

A comparison of pre- and post-treatment blood levels of cobalamin demonstrated for the first time in a large study population that delivery of cyanocobalamin via sublingual lozenges resulted in significant increases in cobalamin blood levels.

Cobalis' chief scientific officer, Ernest Armstrong, said: "Showing a meaningful reduction in allergy symptoms when the symptoms never increased throughout the pollen season to the desired moderate to moderately severe level is next to impossible. It's like trying to prove that a pump can pump water out of a swimming pool when there is almost no water in the pool to begin with.

"Other pharmaceutical companies studying allergy drugs have reported problems with their clinical trials because of low symptom scores in an allergy season, with at least one report in an analogous situation occurring in the 2006 ragweed season when we conducted our trials."

http://www.pharmaceutical-business-review.com/article_news.a…